A randomised, 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
- Conditions
- Moderate to late stage Parkinson's Disease (PD)Nervous System Diseases
- Registration Number
- ISRCTN12870393
- Lead Sponsor
- Biogen Idec (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
Inclusion criteria amended as of 18/06/2007:
1. Male or female subjects, aged 30 to 78 years old, inclusive
2. Must carry a diagnosis of idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria made by a Movement Disorder Specialist, and be Hoehn & Yahr Stage II to IV (inclusive) when 'off'
4. Subjects must be on a stable dose of L-3,4-Dihydroxyphenylalanine (L-DOPA) / carbidopaor L-DOPA / benserazide for at least 4 weeks prior to enrollment
5. Some subjects must demonstrate a definite end of L-DOPA dose wearing off (at least two hours 'off' time per waking day) and must be able to keep accurate patient diaries of PD activity
6. Except for L-DOPA and certain allowed dopamine agonists, must not be receiving any other PD medication (Current treatment with certain dopamine agonists is allowed but must have been on a stable dose for at least 4 weeks prior to enrollment)
Inclusion criteria provided at time of registration:
1. Male or female subjects, aged 30 to 78 years old, inclusive
2. Must carry a diagnosis of idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria made by a Movement Disorder Specialist, and be Hoehn & Yahr Stage II to IV (inclusive) when 'off'
4. Subjects must be on a stable dose of L-3,4-Dihydroxyphenylalanine (L-DOPA)/carbidopa or L-DOPA/benserazide for at least three weeks prior to enrollment
5. Must demonstrate an excellent motor response to L-DOPA, and have a definite end of L-DOPA dose wearing off (at least two hours 'off' time per waking day)
6. Subjects must not be receiving any other PD medications
Exclusion criteria amended as of 18/06/2007:
1. Mini Mental State Examination (MMSE) score of <26
2. History or clinical features consistent with an atypical parkinsonian syndrome
3. Any significant non-PD central nervous system disorder
4. Any significant AXIS I psychiatric disease from the Diagnostic and Statistical Manual of Mental Disorders (DSM)
5. History of surgical intervention for PD
6. History of certain malignancies
7. History of severe allergic anaphylactic reactions to any drug
8. Clinically significant baseline Electrocardiogram (ECG)
9. Orthostatic hypotension
10. HbA1c >7.0%
Exclusion criteria provided at time of registration:
1. Mini Mental State Examination (MMSE) score of less than 27
2. History or clinical features consistent with an atypical parkinsonian syndrome
3. Any significant non-PD central nervous system disorder
4. Any significant AXIS I psychiatric disease from the Diagnostic and Statistical Manual of Mental Disorders (DSM)
5. History of surgical intervention for PD
6. History of malignancy
7. History of severe allergic anaphylactic reactions to any drug
8. Clinically significant baseline Electrocardiogram (ECG)
9. Orthostatic hypotension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The number and proportion of subjects with adverse events <br>2. Assessment of clinical laboratory parameters<br>3. Assessment of vital signs<br>4. Assessment of ECG parameters
- Secondary Outcome Measures
Name Time Method 1. To explore the PharmacoKinetic (PK) drug interactions between BIIB014 and L-DOPA in subjects with moderate to late stage PD<br>2. To explore the PK of BIIB014 when administered as adjunct therapy to subjects with moderate to late stage PD<br>3. To explore the activity of BIIB014 when administered as adjunct therapy to subjects with moderate to late stage PD