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A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers

Study acronym: NAC-preHD
StatusRecruiting
PhasePhase 2
Started2024-06-01
View on ClinicalTrials.gov ↗

Amendment history

2025-02-25
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-11-01→confirmed 2024-06-01
Study sitesdetails revised at 5 of 5 sites
Collaborators6 to 5 entries
University of Sydney
2022-08-21
Study Status, Outcome Measures v1
Secondary endpoints11 entries, revised
Study completion (Safety and Tolerability) Incidence of NACabnormal laboratory values and/or 12-lead ECG changes (Safety and Tolerability) SafetyIncidence of NAC adverse and/or serious adverse events (Safety ofand NACTolerability)
2022-08-18
Original filing
NAC-preHD is a phase II randomized placebo controlled study of oral NAC among premanifest HD gene expansion carriers, with clinical and radiological outcome at three years.
Trial Details
NCT Number NCT05509153
Lead Sponsor Western Sydney Local Health District
Collaborators: Deakin University, Monash University, Royal Perth Hospital, The University of Queensland, University of Melbourne
Conditions Huntington Disease
Enrollment 160 participants
Start Date 2024-06-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-28