Parkinson's Disease
Conditions
Keywords
Moderate to late stage Parkinson's Disease
Brief summary
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: 1. 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 2. 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.
Interventions
DRUGBIIB014
oral administration of BIIB014 at dose to be specified from Part A, given daily for 8 weeks
DRUGPlacebo
Matched placebo for MTD or MTD-1
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and proportion of subjects with adverse events | up to end of study |
| Assessment of clinical laboratory parameters | up to end of study |
| Assessment of vital signs | up to end of study |
| Assessment of ECG parameters. | up to end of study |
Secondary
| Measure | Time frame |
|---|---|
| Assess PK by measuring concentrations of BIIB014 and its N-acetyl metabolite in blood plasma. | up to 24h following last dose (Part A only) |
| Explore activity of BIIB014 by evaluating standard Parkinson's disease assessments | up to 8h following last dose (Part A); up to 24h following last dose (Part B only) |
Countries
India, Israel, United Kingdom
Outcome results
None listed