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
Completed · Phase 2
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00001669
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 15
- Starts
- 1997-07-01
- Expected to finish
- 2000-04-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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