Task Oder 5: RSA Pridopidine: Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis

Grants and Contracts Details

Description

Task Oder 5: RSA Pridopidine : Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis The proposed study is based on cumulative preclinical and clinical studies that demonstrate that pridopidine acts primarily as a Sigma-1 Receptor (S1R) agonist and demonstrates neuroprotective properties mediated by S1R. The purpose of this study is to evaluate the effect of pridopidine 45 mg BID on ALS functional decline, specifically bulbar, upper and lower limb, and respiratory function in participants with ALS. For participants completing the placebo-controlled treatment period of the study, the planned amount of time for a participant in the trial is up to 34 weeks, or about 8 months. This duration assumes a 6-week screening window, a 24-week placebo-controlled treatment period, and a 4-week safety follow-up period for those participants who do not enter the OLE period of the study. Participants will complete approximately 10 study visits during the placebo-controlled period of the study.
StatusActive
Effective start/end date1/17/202/2/25

Funding

  • Massachusetts General Hospital: $34,583.00

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