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Pridopidine Phase 3 Study in Huntington's Disease

Study acronym: PRECISE-HD
StatusRecruiting
PhasePhase 3
SponsorPrilenia
Started2026-07-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-07
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 66 sites
2026-08-04
notable
Study Status, Contacts/Locations v2
Recruitment opened
Trial sites expanded: 0 → 66 locations
Start dateestimated 2026-06→confirmed 2026-07-01
2026-05-29
minor
Study Identification, Study Status v1
Study title-40 characters
PRidopidinePridopidine Phase 3 Study to Establish Clinical Impact and Safety in Huntington's Disease
2026-05-20
minor
Original filing
The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine. The main questions the study aims to answer are: Does pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life? Researchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo. Participants will: Take 1 pridopidine or placebo capsule twice daily for 12 months. Visit the clinic 6 times within 1 year for checkups and tests. All participants who complete this 1-year placebo-controlled study period will roll over into an additional 2-year study period during which all participants will receive pridopidine treatment, including participants who had received placebo during the first year. During this additional 2-year treatment period participants will visit the clinic a total of 6 times for checkups and tests.
Trial Details
NCT Number NCT07609108
Lead Sponsor Prilenia
Collaborators: Ferrer Internacional S.A.
Conditions Huntington Disease
Enrollment 400 participants
Start Date 2026-07-01
Primary Completion 2028-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-30