Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
204PD202
Study information
Scientific title
Acronym
Study hypothesis
To establish a safe and tolerable BIIB014 dose range for future studies in subjects with moderate to late stage Parkinson's Disease (PD).
Ethics approval
Thames Valley Multi-Centre Research Ethics Committee (ref: 06/MRE12/67)
Ethics approval added as of 04/07/2007:
Nizam's Institute of Medical Sciences (India) (ref: EC/NIMS/702©/2007)
Study design
Double-blind, placebo-controlled, multicentre, dose-escalation, single dose/washout/multiple dose study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Moderate to late stage Parkinson's Disease (PD)
Intervention
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 mg/30 mg, 30 mg, 30 mg/100 mg, 50 mg, 100 mg. If patients are randomised to a single dose group they will receive 26 days of treatment (72 hour washout after first dose). If patients are randomised to a two dose group they will receive 28 days of treatment (seven days at the lower dose and 21 days at the higher dose).
Group two: Control treatment - placebo and levodopa treatment. The control group is the standard of care. All doses are in capsule form to be taken once daily in the morning with food.
Intervention type
Drug
Phase
Not Specified
Drug names
BIIB014, levodopa
Primary outcome measure
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 outcome measures
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
Overall trial start date
31/12/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
As of 18/06/2007: 90; At time of registration: 110
Participant exclusion criteria
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
Recruitment start date
31/12/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
India, United Kingdom
Trial participating centre
MRC Clinical Sciences Centre
London
W12 0NN
United Kingdom
Sponsor information
Organisation
Biogen Idec (USA)
Sponsor details
12 Cambridge Center
Bio 6
6th Floor
Cambridge
02142
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Biogen Idec (USA)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list