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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04223193
Registration number
NCT04223193
Ethics application status
Date submitted
7/01/2020
Date registered
10/01/2020
Date last updated
15/04/2024
Titles & IDs
Public title
Flexible-Dose Trial in Early Parkinson's Disease (PD)
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Scientific title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)
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Secondary ID [1]
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2019-002950-22
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Secondary ID [2]
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CVL-751-PD-002
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Universal Trial Number (UTN)
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Trial acronym
TEMPO-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease
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Condition category
Condition code
Neurological
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tavapadon
Treatment: Drugs - Placebo
Experimental: Tavapadon - Participants will receive tavapadon tablet titrated up to 15 milligram (mg) once daily (QD) orally for 27 weeks.
Placebo Comparator: Placebo - Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.
Treatment: Drugs: Tavapadon
Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks.
Treatment: Drugs: Placebo
Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
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Assessment method [1]
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The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscales. Part II contains 13 sub-scores for the motor experiences of daily living and Part III, 33 sub-scores based on 18 items, several with right, left or other body distribution scores for the motor examination. Each sub-score is anchored with 5 responses that are linked to the commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The sub-score for each is summed to calculate the total scores. The scale range for Part II+III Total Score is 0-184 (Part II maximum total score 52 + Part III maximum total score132). The higher the score the greater the severity. A negative change from baseline represents an improvement in motor function.
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Timepoint [1]
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27 Weeks
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Secondary outcome [1]
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Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II Score
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Assessment method [1]
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The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscales. Part II contains 13 sub-scores for the motor experiences of daily living. Each sub-score is anchored with 5 responses that are linked to the commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The sub-score for each is summed to calculate the total scores. The total score range is 0-52. The higher the score the greater the severity. A negative change from baseline represents an improvement in motor function.
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Timepoint [1]
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27 Weeks
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Secondary outcome [2]
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Percentage of Responders with "Much Improved" or "Very Much Improved" on Participant Global Impression of Change (PGIC )
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Assessment method [2]
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The PGIC is the participant-reported outcome. The qualitative assessment of meaningful change will be determined by the participant in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Percentage of responders with much improved and very much improved on PGIC scale will be assessed.
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Timepoint [2]
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27 Weeks
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Secondary outcome [3]
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Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Combined Score
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Assessment method [3]
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The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III combined score will be assessed.
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Timepoint [3]
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27 Weeks
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Secondary outcome [4]
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Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score
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Assessment method [4]
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The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III Individual score will be assessed.
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Timepoint [4]
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29 Weeks
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Secondary outcome [5]
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Change from Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score
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Assessment method [5]
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CGI-S scale is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of the assessment relative to the clinician's past experience with participants who have the same diagnosis. Raters select one response based on the following question: "Considering your total clinical experience with this particular population, how ill is the participant at this time?" Scores are: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score will be assessed.
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Timepoint [5]
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27 Weeks
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Secondary outcome [6]
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Clinical Global Impression - Improvement (CGI-I) Score
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Assessment method [6]
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CGI-I a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to the baseline state at the beginning of the intervention. Raters select one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Clinical Global Impression - Improvement (CGI-I) will be assessed.
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Timepoint [6]
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27 Weeks
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Secondary outcome [7]
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Patient Global Impression of Change (PGIC) Score
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Assessment method [7]
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The PGIC is the participant-reported outcome. The qualitative assessment of meaningful change will be determined by the participant in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.
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Timepoint [7]
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27 Weeks
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Secondary outcome [8]
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Epworth Sleepiness Scale (ESS)
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Assessment method [8]
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ESS is a scale that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated as 0=would never nod off, 1=slight chance of nodding off, 2=moderate chance of nodding off, or 3=high chance of nodding off. A score greater than or equal to (> =) 10 indicates that the patient may need to get more sleep, improve sleep practices, or seek medical attention to determine why he or she is sleepy.
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Timepoint [8]
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27 Weeks
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Secondary outcome [9]
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Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
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Assessment method [9]
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QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.
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Timepoint [9]
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27 Weeks
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Secondary outcome [10]
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Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [10]
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The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
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Timepoint [10]
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27 Weeks
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Secondary outcome [11]
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Number of Participants with Treatment Emergent Adverse Events (TEAEs)
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Assessment method [11]
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An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, Vital Signs, Physical and Neurological evaluations and ECGs will be reported as TEAEs.
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Timepoint [11]
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31 Weeks
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Eligibility
Key inclusion criteria
Key
- Male and female participants aged 40 to 80 years, inclusive, at the time of signing
the informed consent form (ICF).
- Sexually active men or women of childbearing potential must agree to use acceptable
(at minimum) or highly effective birth control, or remain abstinent during the trial
and for 4 weeks after the last dose of trial treatment.
- Participants who are capable of giving signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICF and in the
protocol.
- Participants with a diagnosis of PD that is consistent with the UK Parkinson's Disease
Society Brain Bank diagnostic criteria.
- Participants with modified Hoehn and Yahr stage 1, 1.5, or 2.
- Participants with disease duration (from time of diagnosis) of less than (<) 3 years
and disease progression in the 3 years before signing the ICF.
- Participants with an MDS-UPDRS Part II score >=2 and Part III score >=10 at the
Screening Visit and at the Baseline Visit.
- Participants with early PD who, in the opinion of the investigator, require
pharmacologic intervention for disease management.
- Participants who are treatment naive or have a history of prior incidental treatment
with dopaminergic agents (including L-Dopa and dopamine receptor agonist medications)
for <3 months in total but not within 2 months of the Baseline Visit. Prior and
concurrent use of MAO-B inhibitors is permitted if use was initiated >90 days before
the Baseline Visit and the dosage will remain stable for the duration of the trial
(ie, no change in the MAO-B inhibitor dose is permitted during the trial).
- Participants who are willing and able to refrain from any PD medications that are not
permitted by the protocol (including dopaminergic agents) throughout participation in
the trial.
Key
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Minimum age
40
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants with a history or clinical features consistent with essential tremor,
atypical or secondary parkinsonian syndrome (including, but not limited to,
progressive supra nuclear palsy, multiple system atrophy, cortico-basal degeneration,
or drug-induced or post stroke parkinsonism).
- Participants with a history of nonresponse or insufficient response to L-Dopa at
therapeutic dosages.
- Participants with a history or current diagnosis of a clinically significant impulse
control disorder (Disruptive, Impulse Control, and Conduct Disorder per DSM-5).
- Participants with the presence of or history of brain tumor, hospitalization for
severe head trauma, epilepsy (as defined by the International League Against
Epilepsy), or seizures.
- Participants with a history of psychosis or hallucinations within the previous 12
months.
- Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active
Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal
Ideation with Specific Plan and Intent) and whose most recent episode meeting the
criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR
Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual
attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and
whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal
Behavior Items occurred within the last 2 years, OR Participants who, in the opinion
of the investigator, present a serious risk of suicide.
- Participants with substance abuse or dependence disorder, including alcohol,
benzodiazepines, and opioids, but excluding nicotine, within the past 6 months (180
days).
- Participants with dementia or cognitive impairment that, in the judgement of the
investigator, would exclude the participant from understanding the ICF or
participating in the trial.
- Participants with any condition that could possibly affect drug absorption, including
bowel resections, bariatric weight loss surgery, or gastrectomy (this does not include
gastric banding).
- Participants who have a positive result for human immunodeficiency virus (HIV)
antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies
at screening.
- Participants with a history of myocardial infarction with residual atrial, nodal, or
ventricular arrhythmias that are not controlled with medical and/or surgical
intervention; second- or third-degree atrioventricular block; sick sinus syndrome;
severe or unstable angina; or congestive heart failure within the last 12 months. A
recent (less than or equal to [<=] 12 months) history of myocardial infarction with
secondary arrhythmias is exclusionary regardless of the therapeutic control.
- Participants with a history of neuroleptic malignant syndrome.
- Participants who are currently receiving moderate or strong CYP3A4 inducers or CYP3A4
inhibitors (except for topical administration).
- Participants with a positive urine drug screen for illicit drugs are excluded and may
not be retested or rescreened. Participants with a positive urine drug screen
resulting from use of marijuana (any Tetrahydrocannabinol [THC]-containing product),
prescription, or over-the-counter medications or products that, in the investigator's
documented opinion, do not signal a clinical condition that would impact the safety of
the participant or interpretation of the trial results may continue evaluation for the
trial following consultation and approval by the medical monitor.
- Participants with a Montreal Cognitive Assessment (MoCA) score <26.
- Participants with clinically significant orthostatic hypotension (eg, syncope).
- Participants with a 12-lead ECG demonstrating a QTcF interval >450 msec.
- Participants with moderate or severe renal impairment (creatinine clearance as
estimated by Cockcroft-Gault formula <30 mL/min or on dialysis).
- Participants with any of the following abnormalities in clinical laboratory tests at
the Screening Visit, as assessed by the central laboratory and confirmed by a single
repeat measurement, if deemed necessary:
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >=3 × Upper
Limit Normal (ULN).
- Total bilirubin >=1.5 × ULN. Participants with a history of Gilbert's syndrome
may be eligible provided they have a value <ULN for direct bilirubin.
- Participants with other abnormal laboratory test results, vital sign results, or ECG
findings unless, in the judgment of the investigator, the findings are not medically
significant and would not impact the safety of the participants or the interpretation
of the trial results.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2024
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Actual
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Sample size
Target
296
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney, New South Wales - Sydney
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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Massachusetts
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New York
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Ohio
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Tennessee
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Texas
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Virginia
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Washington
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France
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Marseille
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France
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Nantes
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Gera
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Germany
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Muenchen
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Hungary
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Budapest
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Hungary
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Pécs
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Hungary
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Tatabánya
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Italy
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Cassino
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Italy
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Milano
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Italy
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Rome
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Italy
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Rozzano
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Italy
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Torino
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Korea, Republic of
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Dongdaemun-gu
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Korea, Republic of
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Haeundae-gu
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Korea, Republic of
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Songpa-gu
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Poland
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Cracow
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Poland
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Siemianowice Slaskie
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Poland
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Bydgoszcz
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Poland
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Katowice
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Lublin
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Serbia
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Belgrade
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Pathum Thani
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Thailand
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Ubon Ratchathani
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Vinnitsa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cerevel Therapeutics, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy, safety, tolerability and
pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's
Disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04223193
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Cari Combs, MD
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Address
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Cerevel Therapeutics, LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04223193
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