Moderate to late stage Parkinson's Disease (PD) Nervous System Diseases Moderate to late stage Parkinson's Disease (PD)
Conditions
Interventions
Please note that this trial started in May 2007 and the anticipated trial end date has been extended to March 2008.
Group one: Intervention treatment - BIIB014 at either 5 mg, 5 mg/10 mg, 10 mg, 10
Sponsors
Biogen Idec (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: Exclusion criteria amended as of 18/06/2007: 1. Mini Mental State Examination (MMSE) score of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number and proportion of subjects with adverse events 2. Assessment of clinical laboratory parameters 3. Assessment of vital signs 4. Assessment of ECG parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To explore the PharmacoKinetic (PK) drug interactions between BIIB014 and L-DOPA in subjects with moderate to late stage PD 2. To explore the PK of BIIB014 when administered as adjunct therapy to subjects with moderate to late stage PD 3. To explore the activity of BIIB014 when administered as adjunct therapy to subjects with moderate to late stage PD | — |
Countries
India, United Kingdom
Outcome results
None listed