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

March 3, 2008 updated by: National Institute of Neurological Disorders and Stroke (NINDS)
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Neurological Disorders and Stroke (NINDS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients must be between 18-55 years old; meet the diagnostic criteria for clinical definite or laboratory supported definite MS with either a relapsing remitting or secondary progressive course;

Stage I - known by history to have a mean enhancing lesion frequency of 0.3 per month or greater;

Stage II - known by history to have a mean enhancing lesion frequency of 0.5 per month or greater;

Ability to comply with protocol requirements;

Provide written informed consent;

If a female patient, not of child bearing potential (surgically sterilized or post-menopausal) or if of child bearing potential, documented to be nonpregnant by urine pregnancy test and not lactating with adequate contraception and counseling.

Male patients should also receive adequate counseling and exercise adequate contraception.

No clinically significant abnormalities on the prestudy laboratory evaluations, physical examination, electrocardiogram (ECG), chest x-ray, mammogram or ophthalmologic exam.

No connective tissue or rheumatic disorder (systemic lupus erythematosus [SLE] ; rheumatoid arthritis [RA]; progressive systemic sclerosis [PSS]; Sjogren's syndrome [SS]).

Patient may not be HIV (human immunodeficiency virus), HTLV-1 (human T cell leukemia virus), or HB/C Ag (hepatitis B or C surface antigen) positive.

No history of insulin-producing tumors or reactive hypoglycemia.

No clinically significant medical condition (e.g., within 6 months of screen had myocardial infarction, angina pectoris, untreated hypertension, and/or congestive heart failure [CHF] that, in the opinion of the investigator would compromise the safety of the patient.

Ability to tolerate MRI examinations due to claustrophobia, or have contraindications to MRI scanning, such as pacemakers, aneurysm clips, or shrapnel fragments. Welders and metal workers must have radiographic evidence to document lack of foreign bodies in the eyes or they will be excluded, due to the risk of eye injury while in the MRI machine.

No history of substance use disorder (DSM-IV criteria) within the past two years.

No Type I or Type II diabetes treated with hypoglycemic agents (diet-controlled Type II diabetes may be included.)

No history of cancer (with the exception of localized skin cancers with no evidence of metastasis, significant invasion, or recurrence) within three years of screening.

No first or second degree relatives with breast cancer.

Have not used an investigational drug within 30 days of the screen visit.

Have previously received interferon-alpha, interferon-beta, copolymer 1, cyclophosphamide, intravenous immunoglobulin, oral myelin, or other immunosuppressive drugs within 6 months of screen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Study Completion

April 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

April 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970148
  • 97-N-0148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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