Status:
COMPLETED
Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
Lead Sponsor:
Biogen
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00438607
Start Date
April 1 2007
End Date
April 1 2009
Last Update
July 13 2009
Active Locations (15)
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1
Research Sites
Bangalore, India
2
Research Site
Chennai, India
3
Research Site
Hyderabaad, India
4
Research Site
Ludhiana, India