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

NCT05509153 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Huntington Disease

Interventions

DRUG

NAC

1g of clinical grade N-Acetylcysteine capsules, taken orally twice a day

DRUG

Placebo

Coated Placebo capsules, manufactured to match appearance and taste, taken orally twice a day

Sponsors & Collaborators

  • Deakin University

    collaborator OTHER

  • Monash University

    collaborator OTHER

  • Royal Perth Hospital

    collaborator OTHER

  • The University of Queensland

    collaborator OTHER

  • University of Melbourne

    collaborator OTHER

  • Western Sydney Local Health District

    lead OTHER

Principal Investigators

  • Clement Loy · University of Sydney

  • Yenni Lie · Calvary Health Care Bethlehem

  • Dennis Velakoulis · Melbourne Health

  • Carolyn Orr · Perron Institute

  • John O'Sullivan · The University of Queensland

  • Rob Adam · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-11-01
Completion
2027-05-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05509153 on ClinicalTrials.gov