Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004431
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia
Sponsor:
University of Pittsburgh
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
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:
OBJECTIVES I Evaluate the efficacy of L-baclofen in patients with refractory trigeminal neuralgia
II Evaluate the safety and tolerance of L-baclofen in these patients
II Evaluate the safety and tolerance of L-baclofen in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled parallel study
Patients are randomized to receive either L-baclofen or placebo orally at increasing daily doses for 1 week Patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period
Patients thereafter may enroll in a long term open label study with L-baclofen
Patients are followed at 1 3 6 9 and 12 months
Completion date provided represents the completion date of the grant per OOPD records
Patients are randomized to receive either L-baclofen or placebo orally at increasing daily doses for 1 week Patients then continue to receive the maximum dosage acceptable for a 1 week maintenance period
Patients thereafter may enroll in a long term open label study with L-baclofen
Patients are followed at 1 3 6 9 and 12 months
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPSOM-FDR000914 | None | None | None |
| UPSOM-950686-9608 | None | None | None |