Condition category
Nervous System Diseases
Date applied
08/09/2006
Date assigned
13/09/2006
Last edited
25/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David J Brooks

ORCID ID

Contact details

MRC Clinical Sciences Centre
Faculty of Medicine
Imperial College
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom

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 measures

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

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

http://www.biogenidec.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes