Trial record 2 of 6 for:
biib-014
Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00438607
First received: February 20, 2007
Last updated: July 10, 2009
Last verified: July 2009
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Purpose
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA).
This study will also explore:
- the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and
- the activity of BIIB014 when given to Parkinson's patients who are also taking L-DOPA (this will be done by performing different Parkinson's Disease assessments during the study to examine change in waking OFF time, change in time with troublesome dyskinesia, change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement).
Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking.
The study will be divided into 2 parts:
- Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by
- Part B: a parallel-group exploration of the two highest tolerated doses versus placebo.
Note: As Part A of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to Part B.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: BIIB014 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Levodopa
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Number and proportion of subjects with adverse events [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
- Assessment of clinical laboratory parameters [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
- Assessment of vital signs [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
- Assessment of ECG parameters. [ Time Frame: up to end of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma. [ Time Frame: up to 24h following last dose (Part A only) ] [ Designated as safety issue: No ]
- Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments [ Time Frame: up to 8h following last dose (Part A); up to 24h following last dose (Part B only) ] [ Designated as safety issue: No ]
| Enrollment: | 83 |
| Study Start Date: | April 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
BIIB014 at MTD from Part A
|
Drug: BIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
|
|
2
BIIB014 at dose immediately below MTD from Part A
|
Drug: BIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
|
| Placebo Comparator: 3 |
Drug: Placebo
Matched placebo for MTD or MTD-1
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must carry a diagnosis of idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria, and be Hoehn & Yahr Stage II to IV (inclusive) when OFF.
- Must be on a stable dose of L-3,4-dihydroxyphenylalanine (L-DOPA)/carbidopa or L-DOPA/benserazide for at least 4 weeks prior to enrollment.
- Except for L-DOPA and certain allowed dopamine agonists, must not be receiving any other PD medications. (Current treatment with certain dopamine agonists is allowed but subjects must have been on a stable dose for at least 4 weeks prior to enrollment).
- Some subjects must demonstrate a definite end of L-DOPA dose wearing off (at least 2 hours OFF time per waking day) and must be able to keep accurate patient diaries of PD activity.
Major Exclusion Criteria:
- A Mini Mental State Examination (MMSE) score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome.
- Any significant non-Parkinson's central nervous system disorder.
- Any significant AXIS I psychiatric disease from the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Any previous surgical intervention for Parkinson's Disease.
- History of certain malignancies.
- History of severe allergic anaphylactic reactions to any drug.
- Clinically significant baseline electrocardiogram (ECG).
- Orthostatic hypotension.
- HbA1c >7.0%
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438607
Locations
| India | |
| Research Sites | |
| Bangalore, India | |
| Research Site | |
| Chennai, India | |
| Research Site | |
| Hyderabaad, India | |
| Research Site | |
| Ludhiana, India | |
| Research Site | |
| Mumbai, India | |
| Research Site | |
| New Delhi, India | |
| Research Site | |
| Secunderabad, India | |
| Israel | |
| Research Site | |
| Ashkelon, Israel | |
| Research Site | |
| Jerusalem, Israel | |
| Research Site | |
| Ramat-Gan, Israel | |
| Research Site | |
| Tel Aviv, Israel | |
| United Kingdom | |
| Research Site | |
| Cambridge, United Kingdom | |
| Research Site | |
| Manchester, United Kingdom | |
| Research Site | |
| Norwich, United Kingdom | |
| Research Site | |
| Salford, United Kingdom | |
Sponsors and Collaborators
Biogen Idec
Investigators
| Study Director: | Biogen Idec | Cambridge, MA USA |
More Information
No publications provided
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00438607 History of Changes |
| Other Study ID Numbers: | 204PD202, EUDRA CT NO: 2006-003490-27, ISCRTN 12870393 |
| Study First Received: | February 20, 2007 |
| Last Updated: | July 10, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency India: Ministry of Health Israel: Ministry of Health |
Keywords provided by Biogen Idec:
|
Moderate to late stage Parkinson's Disease |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013