Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079495
Status:
COMPLETED
Last Update Posted:
2008-03-21
First Post:
2004-03-08
Brief Title:
Evaluation of an Altered Peptide Ligand NBI-5788 in Patients With Relapsing Multiple Sclerosis MS
Sponsor:
Neurocrine Biosciences
Organization:
Neurocrine Biosciences
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are studying this investigational drug treatment comparing it with placebo to evaluate whether it is effective in reducing the number of MRI lesions with a minimum number of side effects The investigational drug will be administered in the clinic weekly for 5 injections induction phase then monthly for 8 additional injections maintenance phase
Approximately 150 male and female patients 100 active and 50 placebo aged 18 to 55 years with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial MRI scans during the run-in phase will be randomized into this study
Approximately 150 male and female patients 100 active and 50 placebo aged 18 to 55 years with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial MRI scans during the run-in phase will be randomized into this study
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled trial in which qualifying patients will be randomized 21 to receive active drug or placebo Eligible patients must have MS with relapse have had one or more relapses during the prior 2 years 1-10 gadolinium Gd-enhancing lesions on the Run-in MRI and an EDSS of 65 or less There are exclusions for certain prior MS treatments and medical psychiatric conditions Following a 4-week run-in phase in which patients will have a baseline MRI patients will enter a 4 week induction phase during which they will be receive injections weekly 5 doses then a 32-week maintenance phase during which injections are monthly 8 doses A final follow-up visit will be conducted 4 weeks after the last injection The primary efficacy parameter is a summary change score of the mean number of total Gd-enhancing lesions at weeks 36 and 40 minus the mean number for the two baseline scans Safety monitoring will include AESAE reporting physical exams vital signs ECG CXR laboratory tests neurologic evaluations and systemic hypersensitivity and injection site assessments All study medications will be administered by study personnel and patients will remain under observation for a minimum of 2 hours post-injection An independent Data Safety and Monitoring Board will oversee the safety of the trial
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 |
|---|---|---|---|
| Neurocrine | None | None | None |
| MS APL | None | None | None |