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
| ISRCTN | ISRCTN12870393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12870393 |
| Secondary identifying numbers | 204PD202 |
- Submission date
- 08/09/2006
- Registration date
- 13/09/2006
- Last edited
- 25/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David J Brooks
Scientific
Scientific
MRC Clinical Sciences Centre
Faculty of Medicine
Imperial College
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 31/12/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | As of 18/06/2007: 90; At time of registration: 110 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/12/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- India
- United Kingdom
Study participating centre
MRC Clinical Sciences Centre
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Sponsor information
Biogen Idec (USA)
Industry
Industry
12 Cambridge Center
Bio 6, 6th Floor
Cambridge
02142
United States of America
| Website | http://www.biogenidec.com/ |
|---|---|
"ROR" |
https://ror.org/02jqkb192 |
Funders
Funder type
Industry
Biogen Idec (USA)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
