Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
NCT ID: NCT00438607
Last Updated: 2009-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2007-04-30
2009-04-30
Brief Summary
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This study will also explore:
1. 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
2. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
BIIB014 at MTD from Part A
BIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
2
BIIB014 at dose immediately below MTD from Part A
BIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
3
Placebo
Matched placebo for MTD or MTD-1
Interventions
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BIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
Placebo
Matched placebo for MTD or MTD-1
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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%
30 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Principal Investigators
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Biogen Idec
Role: STUDY_DIRECTOR
Cambridge, MA USA
Locations
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Research Sites
Bangalore, , India
Research Site
Chennai, , India
Research Site
Hyderabaad, , India
Research Site
Ludhiana, , India
Research Site
Mumbai, , India
Research Site
New Delhi, , India
Research Site
Secunderabad, , India
Research Site
Ashkelon, , Israel
Research Site
Jerusalem, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Cambridge, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Norwich, , United Kingdom
Research Site
Salford, , United Kingdom
Countries
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Other Identifiers
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EUDRA CT NO: 2006-003490-27
Identifier Type: -
Identifier Source: secondary_id
ISCRTN 12870393
Identifier Type: -
Identifier Source: secondary_id
204PD202
Identifier Type: -
Identifier Source: org_study_id
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