Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS)

NCT00001781 | Completed Phase 2

• 2 other identifiers: 98006998-N-0069
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown, but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that cause the body's immune system and natural defenses to attack healthy cells. In the case of MS, the immune system begins attacking myelin, the cells that make up the sheath covering nerves. Without myelin nerves are unable to transmit signals effectively and symptoms occur. Researchers are interested in testing the safety, tolerability, and effectiveness of a new therapy (CGP77116) for Multiple Sclerosis (MS). CGP77116 is a small protein similar to the protein in myelin. CGP77116 is designed to modify the immune reaction that destroys normal myelin. CGP77116 is an experimental therapy meaning it has not been approved by the U.S. Food and Drug Administration. However, in preliminary studies on animal it has been shown to be effective at modifying the autoimmune reaction associated with the development of MS. The purpose of this study is to assess the safety and effect of CGP77116 on disease activity in patients with Multiple Sclerosis as measured by magnetic resonance imaging (MRI) and immunological studies. The study is broken into three parts: I) BASELINE: in the first part of the study patients will undergo 6 MRIs over a 5 month period. During this time, patients will be evaluated based on the presence of MS lesions seen on MRI. Patients whose MS lesions are highly active will be entered into the second part of the study. II) TREATMENT: in the second part of the study, patients with active MS lesions will begin receiving CGP77116. The drug will be given by injection once a week for one month and then once a month for 8 additional months. III) FOLLOW-UP: in the third and final part of the study, patients will undergo an MRI every 2 months for 6 months and then every 3 months for 6 additional months. The results of the MRIs will be used to measure the effectiveness of CGP77116.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Immunology; Treatment

Interventions

CGP 77116 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Patients with clinically definite and/or laboratory-supported definite diagnosis of MS. Patients must have had a minimum of 6 monthly MRI scans prior to randomization according to a standardized MRI protocol and fulfill the pre-defined MRI criteria of disease activity: mean of at least 0.5 total gadolinium-enhancing lesion in the 6 monthly scans immediately preceding randomization. No evidence of relapse for at least 30 days prior to entry. One or more relapses in the 2 years preceding randomization. Expanded Disability Status Scale (EDSS) score less than or equal to 7.0. Male or female aged 18 to 55 years. Females must be either post-menopausal, surgically incapable of bearing children, or practicing a medically accepted method of birth control. Patients willing and able to give informed consent according to national legal requirements.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Martin R, Howell MD, Jaraquemada D, Flerlage M, Richert J, Brostoff S, Long EO, McFarlin DE, McFarland HF. A myelin basic protein peptide is recognized by cytotoxic T cells in the context of four HLA-DR types associated with multiple sclerosis. J Exp Med. 1991 Jan 1;173(1):19-24. doi: 10.1084/jem.173.1.19.

  PMID: 1702137 BACKGROUND

• Vergelli M, Hemmer B, Utz U, Vogt A, Kalbus M, Tranquill L, Conlon P, Ling N, Steinman L, McFarland HF, Martin R. Differential activation of human autoreactive T cell clones by altered peptide ligands derived from myelin basic protein peptide (87-99). Eur J Immunol. 1996 Nov;26(11):2624-34. doi: 10.1002/eji.1830261113.

  PMID: 8921948 BACKGROUND

• McFarland HF, Frank JA, Albert PS, Smith ME, Martin R, Harris JO, Patronas N, Maloni H, McFarlin DE. Using gadolinium-enhanced magnetic resonance imaging lesions to monitor disease activity in multiple sclerosis. Ann Neurol. 1992 Dec;32(6):758-66. doi: 10.1002/ana.410320609.

  PMID: 1471866 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

CGP 77116

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: February 1, 1998
• Study Completion: March 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-03

Locations

US (1)