Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
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.