Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438607
Status:
COMPLETED
Last Update Posted:
2009-07-13
First Post:
2007-02-20
Brief Title:
Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinsons Disease
Sponsor:
Biogen
Organization:
Biogen
Study Overview
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 Parkinsons Disease Who Are Also Receiving Treatment With Levodopa
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons Disease who are also taking the Parkinsons medication levodopa L-DOPA
This study will also explore
1 the pharmacokinetics of BIIB014 in Parkinsons 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 Parkinsons patients who are also taking L-DOPA this will be done by performing different Parkinsons 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 eg number of study arms pertains only to Part B
This study will also explore
1 the pharmacokinetics of BIIB014 in Parkinsons 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 Parkinsons patients who are also taking L-DOPA this will be done by performing different Parkinsons 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 eg number of study arms pertains only to Part B
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISCRTN 12870393 | None | None | None |
| EUDRA CT NO 2006-003490-27 | None | None | None |