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

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Nov 3, 1999

Keywords

ClinConnect Summary

This trial will evaluate safety, tolerability and effect on cranial magnetic resonance imaging (MRI) and immune response of CGP 77116 in patients with the demyelinating autoimmune disease, multiple sclerosis (MS). The purpose of the trial is to assess whether CGP 77116 modifies inflammatory disease activity as measured by MRI and immunological techniques, and to facilitate dose selection for future pivotal trials in progressive and relapsing-remitting MS.

CGP 77116 is an altered peptide ligand (APL) designed around an immunodominant epitope of human myelin basic protein (MBP) corresponding...

Gender

ALL

Eligibility criteria

• • 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.