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NCT00001669 · ClinicalTrials.gov registry record · Phase 2
A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00001669 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 15 participants.
The verdict
NCT00001669, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DRUG rhIGF-1 (CEP-151)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1997-07 |
| Est. Completion | 2000-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001669
The ClinicalTrials.gov registry entry for NCT00001669 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rhIGF-1 (CEP-151) is the first listed.
NCT00001669 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001669 about?
NCT00001669 is a clinical study titled "A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients". 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...
What is the current status of trial NCT00001669?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 1997-07. Estimated completion is 2000-04.
What interventions are being tested in trial NCT00001669?
The interventions under investigation include: rhIGF-1 (CEP-151) (DRUG).
Who is sponsoring clinical trial NCT00001669?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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