A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

Summary

This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).

Timeline

Start

2014-02-28

Primary completion

2015-12-16

Completion

2016-07-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Pridopidine 45 mg BID; p = 0.3202; LSM difference 1.42 (95% CI -1.39 to 4.23); Mixed Models Analysis NCT02006472 ↗

paper Pridopidine did not significantly change the UHDRS-TMS at 26 weeks compared with placebo at any dose. PMID 30563778 ↗

Publications

• Background McGarry A, Leinonen M, Kieburtz K, Geva M, Olanow CW, Hayden M. Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study. J Huntingtons Dis. 2020;9(4):371-380. doi: 10.3233/JHD-200440.
• 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.
• Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001.
• Reilmann R, McGarry A, Grachev ID, Savola JM, Borowsky B, Eyal E, Gross N, Langbehn D, Schubert R, Wickenberg AT, Papapetropoulos S, Hayden M, Squitieri F, Kieburtz K, Landwehrmeyer GB; European Huntington's Disease Network; Huntington Study Group investigators. Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. Lancet Neurol. 2019 Feb;18(2):165-176. doi: 10.1016/S1474-4422(18)30391-0. Epub 2018 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pridopidine	Small molecule	45 mg	Oral
Subject	Pridopidine	Small molecule	67.5 mg	Oral
Subject	Pridopidine	Small molecule	90 mg	Oral
Subject	Pridopidine	Small molecule	112.5 mg	Oral

Indications