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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/NCT04909502
Registration number
NCT04909502
Ethics application status
Date submitted
14/05/2021
Date registered
1/06/2021
Date last updated
21/10/2022
Titles & IDs
Public title
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis
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Scientific title
A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
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Secondary ID [1]
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EHP-101-MS02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing Forms of Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EHP-101 25 mg OD
Treatment: Drugs - EHP-101 25 mg BID
Treatment: Drugs - EHP-101 50 mg OD
Treatment: Drugs - EHP-101 50 mg BID
Experimental: EHP-101 Once a day (OD) -
Experimental: EHP-101 Twice a day (BID) -
Treatment: Drugs: EHP-101 25 mg OD
25 mg OD during the first 28 Days of the trial
Treatment: Drugs: EHP-101 25 mg BID
25 mg BID during the first 28 Days of the trial
Treatment: Drugs: EHP-101 50 mg OD
After 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial
Treatment: Drugs: EHP-101 50 mg BID
After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial
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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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Incidence and severity of Treatment Emergent Adverse Events
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Assessment method [1]
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This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments
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Timepoint [1]
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168 days (24 weeks)
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Secondary outcome [1]
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Brain lesion activity measured by MRI
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Assessment method [1]
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Timepoint [1]
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168 days (24 weeks)
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Secondary outcome [2]
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Disease progression measured by MS Functional Composite (MSFC)
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Assessment method [2]
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The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality
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Timepoint [2]
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168 days (24 weeks)
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Secondary outcome [3]
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Disease progression measured by Expanded Disability Status Scale (EDSS)
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Assessment method [3]
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The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner
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Timepoint [3]
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168 days (24 weeks)
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Secondary outcome [4]
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Disease progression measured by Symbol Digit Modalities Test (SDMT)
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Assessment method [4]
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The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution
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Timepoint [4]
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168 days (24 weeks)
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Secondary outcome [5]
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Disability status measured by MS Functional Composite (MSFC)
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Assessment method [5]
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The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality
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Timepoint [5]
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168 days (24 weeks)
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Secondary outcome [6]
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Disability status measured by Expanded Disability Status Scale (EDSS)
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Assessment method [6]
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The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner
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Timepoint [6]
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168 days (24 weeks)
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Secondary outcome [7]
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Disability status measured by Symbol Digit Modalities Test (SDMT)
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Assessment method [7]
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The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution
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Timepoint [7]
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168 days (24 weeks)
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Secondary outcome [8]
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Time to first relapse
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Assessment method [8]
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Timepoint [8]
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168 days (24 weeks)
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Secondary outcome [9]
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Preliminary Annualized Relapse Rate (ARR)
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Assessment method [9]
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Timepoint [9]
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168 days (24 weeks)
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Secondary outcome [10]
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Percent of patients who experience a relapse
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Assessment method [10]
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Timepoint [10]
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168 days (24 weeks)
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Secondary outcome [11]
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Proportion of patients who remain qualified as relapse-free
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Assessment method [11]
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Timepoint [11]
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168 days (24 weeks)
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Secondary outcome [12]
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Change in blood levels of neurofilament light chain (NfL)
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Assessment method [12]
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Timepoint [12]
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Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days
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Eligibility
Key inclusion criteria
- Male and female adults aged 18 to 55 years at the time of consent;
- Confirmed diagnosis of MS according to the revised 2017 McDonald criteria;
- Relapsing forms of MS (RMS) including Relapsing-Remitting MS (RRMS) and active
Secondary Progressive MS (SPMS);
- Patients must have experienced at least 1 of the following within 12 months prior to
Visit 1: an acute clinical relapse, gadolinium-enhancing T1 lesions on brain or spinal
cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord
MRI;
- Neurologically stable with no evidence of clinical relapse of MS or corticosteroid
treatment within 28 days prior to the first investigational product administration;
- Naïve to prior MS treatment or discontinuing current MS treatment due to (1)
intolerability, (2) laboratory abnormalities, (3) current treatment perceived by the
patient to be ineffective, (4) patient preference, or (5) based on investigator
judgement to switch MS therapy;
- An EDSS score of 0 to 6.0 (inclusive) at screening and enrolment visit;
- Willing and able to provide informed consent and capable of understanding and
complying with the protocol.
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Minimum age
18
Years
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Maximum age
55
Years
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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
- Primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS);
- Relapse during the 28 days prior to first investigational product administration;
- Total lymphoid irradiation, T-cell or T-cell receptor vaccination, total body
irradiation, or total lymphoid irradiation at any time;
- Treatment with alemtuzumab, mitoxantrone, cyclophosphamide or cladribine at any time;
- MS treatment that may impact the efficacy or safety assessment defined as follows:
1. 52 weeks or less prior to first investigational product administration:
Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)
2. 36 weeks or less prior to first investigational product administration: CD20
depletion therapies such as rituximab, ocrelizumab, ofatumumab or others.
Condition for inclusion of patients who had CD20 depletion therapies more than 36
weeks prior to the first investigational product administration: may only be
included if there is no clinically relevant B cell depletion and possible safety
risk to patients based on the Investigator's opinion.
3. 12 weeks or less prior to first investigational product administration:
natalizumab
4. 8 weeks or less prior to first investigational product administration:
dimethyl-fumarate fingolimod
5. 4 weeks or less prior to first investigational product administration:
corticosteroids intravenous immunoglobulin (IVIG) ozanimod, siponimod, or
ponesimod glatiramer acetate interferons
6. 2 weeks or less prior to first investigational product administration:
teriflunomide. Subject must exhibit no active agent in serum levels;
cholestyramine or activated charcoal washout may be used to achieve this;
- Any one of the following values for laboratory test at screening:
1. Haemoglobin < 9 g/dL;
2. Neutrophils < 1.0 x 10^9/L;
3. Platelets < 75 x 10^9/L;
4. Serum transaminases > 2.0 x upper limit of normal;
5. Total bilirubin = 1.5 x upper limit of normal;
6. Thyroid-stimulating hormone level >10% above of the upper limit of normal;
7. Estimated glomerular filtration rate =60 mL/min/1.73m2 (using the Cockcroft-Gault
equation);
8. Lymphocytes < 1 × 10^9/L;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Suspended
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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
19/10/2021
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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
1/04/2024
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St. Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3065 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Emerald Health Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and
preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis
(RMS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04909502
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04909502
Download to PDF