Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001669
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A 48-Week 24-Week Baseline Followed by a 24-Week Treatment Phase II Pilot Study of the Tolerability and EffectEfficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 rhIGF CEP-151 in Multiple Sclerosis MS Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A 48-Week 24-Week Baseline Followed by a 24-Week Treatment Phase II Pilot Study of the Tolerability and EffectEfficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 rhIGF CEP-151 in Multiple Sclerosis MS Patients
Status:
COMPLETED
Status Verified Date:
1999-04
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:
The drug rhIGF-1 CEP-151 has been shown to play a key role preclinically in oligodendrocyte differentiation and survival as well as myelin integrity and function Moreover in an animal model of MS myelin expression as well as that of its receptors is upregulated at the time the myelin sheaths regenerate Finally administration of exogenous rhIGF-1 to rats with EAE effectively closes the disrupted BBB reduces the number and severity of demyelinating lesions and improves neurological function Thus it seems reasonable to examine the efficacy and safety tolerability and effect of CEP-151 on brain MRI lesions in patients with MS
Detailed Description:
The drug rhIGF-1 CEP-151 has been shown to play a key role preclinically in oligodendrocyte differentiation and survival as well as myelin integrity and function Moreover in an animal model of MS myelin expression as well as that of its receptors is upregulated at the time the myelin sheaths regenerate Finally administration of exogenous rhIGF-1 to rats with EAE effectively closes the disrupted BBB reduces the number and severity of demyelinating lesions and improves neurological function Thus it seems reasonable to examine the efficacy and safety tolerability and effect of CEP-151 on brain MRI lesions in patients with MS
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 |
|---|---|---|---|
| 97-N-0148 | None | None | None |