CRISP Trial Update: Suitability of Antipsychotic Medications for MS
Participants in the CRISP trial will be randomly assigned to receive either clozapine, risperidone, or placebo.
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Parameters of the upcoming CRISP trial have been announced at the 2018 ACTRIMS Forum held in San Diego, California.
Researchers from New Zealand are conducting a blinded, randomized, placebo-controlled trial (CRISP; Clozapine and Risperidone for the Treatment of Progressive Multiple Sclerosis; ACTRN12616000178448) of patients with progressive multiple sclerosis (MS) to determine whether clozapine and risperidone can reduce neuroinflammation.
Participants will be randomly assigned to 1 of 3 arms, receiving either 100 mg/day clozapine for 3 months followed by 150 mg/day for 3 months; 2 mg/day risperidone for 3 months followed by 3.5 mg/day risperidone for 3 months; or placebo for 6 months.
Parameters including measures of MS — the expanded disability status scale, an MS functional composite score, and a fatigue severity scale — treatment acceptability, measured by questionnaire, and immunologic markers, including blood counts and an immune phenotype profile, will be collected at baseline and at 3 and 6 months. Primary study outcomes are rates of adverse and serious adverse events and treatment acceptability.
Data from a formal interim analysis will be presented at a future date.
“The CRISP trial will determine the suitability of two atypical antipsychotics, clozapine and risperidone, for people with progressive MS, and the results will guide the design of future trials to assess clinical efficacy,” the researchers concluded.
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La Flamme AC, Abernathy D, Sim D, et al. Crisp: Clozapine and risperidone for the treatment of progressive multiple sclerosis. Presented at: ACTRIMS Forum 2018; February 1-3, 2018; San Diego, CA. Abstract P031.