Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01550484




Registration number
NCT01550484
Ethics application status
Date submitted
6/03/2012
Date registered
12/03/2012
Date last updated
9/02/2017

Titles & IDs
Public title
A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders
Scientific title
An Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain Diagnosis
Secondary ID [1] 0 0
18F-AV-133-B04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 0 0
Primary Parkinsonism 0 0
Lewy Body Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 18F-AV-133

Treatment: Drugs: 18F-AV-133
222 MBq (6 mCi)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity of visual read of AV-133 PET scan vs. standard of truth
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Specificity of visual read of AV-133 PET scan vs. standard of truth
Timepoint [2] 0 0
18 months
Secondary outcome [1] 0 0
Inter-rater reliability of the visual read
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Intra-rater reliability of the visual read
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Probability of progressive motor skill impairment
Timepoint [3] 0 0
18 months

Eligibility
Key inclusion criteria
* Males or females = 40 years of age;
* Presenting (within the last 3 months) for an initial evaluation to a movement disorders specialist with signs or symptoms suggestive of a movement disorder;
* The subject's signs or symptoms were previously evaluated by a physician who was not a movement disorders specialist during the previous six months;
* Absence of an established clinical movement disorder diagnosis;
* Symptoms mild in intensity, this includes Hoehn & Yahr = 2 (Exceptions are allowed for subjects who meet criteria for Hoehn & Yahr stage 3 due to early onset of postural instability and/or gait impairment out of proportion to his/her other Parkinson signs and symptoms);
* Montreal Cognitive Assessment (MoCA) score = 22;
* Can tolerate imaging visit procedures; and
* Provide written informed consent prior to study entry.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have been referred to the movement disorders clinic primarily for the purpose of disease management (no diagnostic uncertainty exists on the part of the non-specialist or referring physician);
* Have a previous movement disorder diagnosis given by a movement disorders specialist prior to the time of enrollment;
* Have received a total of more than 90 days treatment with dopaminergic medications, including direct dopamine agonists or precursors (levodopa) or have received a total of more than 180 days treatment with MAO-B inhibitors, amantadine, anticholinergics or primidone or beta-blockers prescribed for treatment of tremor or signs of parkinsonism;
* Have had a sustained and clinically meaningful response to anti-parkinsonian medications;
* Are currently taking or have taken MAO-B inhibitors in the past 4 weeks;
* Have a known CNS structural lesion such as stroke or tumor that likely accounts for their symptoms;
* Have clinically meaningful cognitive impairment or dementia (mild cognitive problems as might be expected in the earliest stages of PD are not exclusionary);
* Have current clinically significant cardiovascular disease or clinically important abnormalities on screening ECG (including but not limited to QTc > 450 msec);
* Are currently taking medications that are known to cause QT-prolongation;
* Are currently taking medications with narrow therapeutic windows (e.g. warfarin or other anticoagulant therapies);
* Are currently taking tetrabenazine (TBZ), amphetamine type drugs;
* Have a current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer (excluding localized basal cell carcinoma and in situ prostate cancer) that would interfere with completion of the study;
* Have a recent history (within the past year) of alcohol or substance abuse or dependence;
* Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable contraception. Females must not be pregnant (negative serum beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging), must not be breastfeeding at screening, must avoid becoming pregnant and use adequate contraceptive methods for 14 days prior to and 24 hours after administration of 18F-AV-133 for injection;
* Have had prior intracranial surgery; and
* Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Avid Radiopharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer
Address 0 0
Avid Radiopharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01550484