- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442780
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease (MOBILE)
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's Disease
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.
This study will also explore:
- How BIIB014 is affected when given to patients with early-stage Parkinson's Disease (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and
- The activity of BIIB014 when given to early Parkinson's patients (this will be done by performing different Parkinson's Disease assessments and other tests during the study).
Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ashkelon, Israel
- Research Site
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Petach Tikva, Israel
- Research Site
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Ramat-Gan, Israel
- Research Site
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Tel Aviv, Israel
- Research Site
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-
-
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Kielce, Poland
- Research Site
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Krakow, Poland
- Research Site
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Poznan, Poland
- Research Site
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Warszawa, Poland
- Research Site
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Belgrade, Serbia
- Research Site
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Belgrade, Serbia
- Research Sites
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must give written informed consent and any authorizations required by local law.
- Must carry a diagnosis of idiopathic Parkinson's Disease(PD), without any other known or suspected cause of parkinsonism, according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
- Must be modified Hoehn & Yahr Stage 1 to 2.5 (inclusive).
- Must have a baseline UPDRS (Part III) motor score of at least 10.
- Subjects may be receiving an anticholinergic agent and/or MAO-B inhibitor (if they have been on a stable dose of that medication for at least 4 weeks prior to study entry) but must not be receiving any other PD medication.
Exclusion Criteria:
- A Mini Mental State Examination (MMSE) score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome.
- Any significant non-PD central nervous system disorder.
- Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders.
- History of cognitive or neuropsychiatric conditions.
- History of surgical intervention for PD.
- History of L-DOPA-induced motor or non-motor complication.
- History of malignancy.
- History of severe allergic or anaphylactic reactions to any drug.
- Clinically significant renal dysfunction.
- HbA1c >7.0%.
- Clinically significant baseline ECG.
- Orthostatic hypotension.
- Treatment with L-DOPA/carbidopa or L-DOPA/benserazide for more than 6 cumulative months at anytime since subject's initial PD diagnosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Dose Level A of BIIB014
|
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
|
Placebo Comparator: 2
Dose Level B of BIIB014
|
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
|
Placebo Comparator: 3
Dose Level C of BIIB014
|
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
|
Placebo Comparator: 4
Dose Level D of BIIB014
|
oral administration of BIIB014 per dose, schedule,and duration specified in protocol
Oral administration of placebo matched to BIIB014 dose level; placebo to follow same dosing schedule as BIIB014
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and proportion of subjects with adverse events
Time Frame: up to end of study
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up to end of study
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Assessment of clinical laboratory parameters.
Time Frame: up to end of study
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up to end of study
|
Assessment of vital signs.
Time Frame: up to end of study
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up to end of study
|
Assessment of ECG parameters.
Time Frame: up to end of study
|
up to end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Time Frame: up to end of study
|
up to end of study
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Explore BIIB014 activity by evaluating standard Parkinson's disease assessments.
Time Frame: up to end of study
|
up to end of study
|
Explore the PK/pharmacodynamic relationships for BIIB014.
Time Frame: up to end of study
|
up to end of study
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Biogen Idec, MD, Cambridge, MA USA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Purinergic Antagonists
- Purinergic Agents
- Purinergic P1 Receptor Antagonists
- Adenosine A2 Receptor Antagonists
- 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine
Other Study ID Numbers
- 204PD203
- EUDRA CT NO: 2007-000398-47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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