Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB014
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Moderate to late stage Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Must carry a diagnosis of idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria, and be Hoehn & Yahr Stage II to IV (inclusive) when OFF.
- Must be on a stable dose of L-3,4-dihydroxyphenylalanine (L-DOPA)/carbidopa or L-DOPA/benserazide for at least 4 weeks prior to enrollment.
- Except for L-DOPA and certain allowed dopamine agonists, must not be receiving any other PD medications. (Current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
- Some subjects must demonstrate a definite end of L-DOPA dose wearing off (at least 2 hours OFF time per waking day) and must be able to keep accurate patient diaries of PD activity.
Major Exclusion Criteria:
- A Mini Mental State Examination (MMSE) score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome.
- Any significant non-Parkinson's central nervous system disorder.
- Any significant AXIS I psychiatric disease from the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Any previous surgical intervention for Parkinson's Disease.
- History of certain malignancies.
- History of severe allergic anaphylactic reactions to any drug.
- Clinically significant baseline electrocardiogram (ECG).
- Orthostatic hypotension.
- HbA1c >7.0%
Sites / Locations
- Research Sites
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Placebo Comparator
Arm Label
1
2
3
Arm Description
BIIB014 at MTD from Part A
BIIB014 at dose immediately below MTD from Part A
Outcomes
Primary Outcome Measures
Number and proportion of subjects with adverse events
Assessment of clinical laboratory parameters
Assessment of vital signs
Assessment of ECG parameters.
Secondary Outcome Measures
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00438607
Brief Title
Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With Levodopa
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).
This study will also explore:
the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (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 Parkinson's patients who are also taking L-DOPA (this will be done by performing different Parkinson's Disease assessments during the study to examine change in waking OFF time, change in time with troublesome dyskinesia, change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement).
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.
The study will be divided into 2 parts:
Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by
Part B: a parallel-group exploration of the two highest tolerated doses versus placebo.
Note: As Part A of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to Part B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Moderate to late stage Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
BIIB014 at MTD from Part A
Arm Title
2
Arm Type
Other
Arm Description
BIIB014 at dose immediately below MTD from Part A
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BIIB014
Intervention Description
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo for MTD or MTD-1
Primary Outcome Measure Information:
Title
Number and proportion of subjects with adverse events
Time Frame
up to end of study
Title
Assessment of clinical laboratory parameters
Time Frame
up to end of study
Title
Assessment of vital signs
Time Frame
up to end of study
Title
Assessment of ECG parameters.
Time Frame
up to end of study
Secondary Outcome Measure Information:
Title
Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma.
Time Frame
up to 24h following last dose (Part A only)
Title
Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments
Time Frame
up to 8h following last dose (Part A); up to 24h following last dose (Part B only)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must carry a diagnosis of idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria, and be Hoehn & Yahr Stage II to IV (inclusive) when OFF.
Must be on a stable dose of L-3,4-dihydroxyphenylalanine (L-DOPA)/carbidopa or L-DOPA/benserazide for at least 4 weeks prior to enrollment.
Except for L-DOPA and certain allowed dopamine agonists, must not be receiving any other PD medications. (Current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
Some subjects must demonstrate a definite end of L-DOPA dose wearing off (at least 2 hours OFF time per waking day) and must be able to keep accurate patient diaries of PD activity.
Major Exclusion Criteria:
A Mini Mental State Examination (MMSE) score <26.
History or clinical features consistent with an atypical parkinsonian syndrome.
Any significant non-Parkinson's central nervous system disorder.
Any significant AXIS I psychiatric disease from the Diagnostic and Statistical Manual of Mental Disorders (DSM).
Any previous surgical intervention for Parkinson's Disease.
History of certain malignancies.
History of severe allergic anaphylactic reactions to any drug.
Clinically significant baseline electrocardiogram (ECG).
Orthostatic hypotension.
HbA1c >7.0%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen Idec
Organizational Affiliation
Cambridge, MA USA
Official's Role
Study Director
Facility Information:
Facility Name
Research Sites
City
Bangalore
Country
India
Facility Name
Research Site
City
Chennai
Country
India
Facility Name
Research Site
City
Hyderabaad
Country
India
Facility Name
Research Site
City
Ludhiana
Country
India
Facility Name
Research Site
City
Mumbai
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Secunderabad
Country
India
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Ramat-Gan
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Norwich
Country
United Kingdom
Facility Name
Research Site
City
Salford
Country
United Kingdom
12. IPD Sharing Statement
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Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
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