A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease

Phase 2 Completed 227 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.

Timeline

Start: 2008-10-24
Primary completion: 2010-07-26
Completion: 2010-07-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs ACR16 45 mg BID; p = 0.078; Mean Difference (Final Values) -1.17 (95% CI -2.47 to 0.13); ANCOVA NCT00724048 ↗

Publications

Darpo B, Geva M, Ferber G, Goldberg YP, Cruz-Herranz A, Mehra M, Kovacs R, Hayden MR. Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose. Neurol Ther. 2023 Apr;12(2):597-617. doi: 10.1007/s40120-023-00449-w. Epub 2023 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pridopidine	Small molecule	10 mg	Oral
Subject	Pridopidine	Small molecule	22.5 mg	Oral
Subject	Pridopidine	Small molecule	45 mg	Oral