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

Sponsor
Western Sydney Local Health District
Study ID
NCT05509153
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NAC — DRUG
    1g of clinical grade N-Acetylcysteine capsules, taken orally twice a day
  • Placebo — DRUG
    Coated Placebo capsules, manufactured to match appearance and taste, taken orally twice a day

Study Details

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.

Key Dates

First listed
Aug 19, 2022
Start date
Jun 1, 2024
Status verified
Feb 2025
Primary completion
Nov 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NAC
    1g N-Acetylcysteine capsules, taken orally twice a day.
  • Placebo Comparator: Placebo
    Coated Placebo capsules, taken orally twice a day

Primary Outcome Measure

Caudate Atrophy Rate on volumetric MRI [ Time Frame: Baseline through end of study (up to 3 years) ]

Central Contacts

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