Phase 2 Huntington's Disease Trial, Terminated NCT03225833 Sponsor: Wave Life Sciences USA, Inc. Condition: Huntington's Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03225833) enrolled 61 people in total across six groups: 16 received a placebo (an inactive substance used for comparison), and the remaining 45 received one of five different doses of an experimental drug called WVE-120101 — either 2 mg, 4 mg, 8 mg, 16 mg, or 32 mg. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) after receiving the drug or placebo, and also tracked how the drug moved through the body over time. The reported data shows that when it came to any adverse event during the study, 12 of the 16 placebo participants experienced at least one, compared to 8, 8, 9, 7, and 9 participants in the five WVE-120101 dose groups respectively. For serious adverse events — defined as those involving hospitalisation, life-threatening situations, or lasting disability — none occurred in the placebo group, while 2, 1, 0, 0, and 4 participants experienced them across the five dose groups from lowest to highest dose. Regarding severe adverse events specifically, the numbers reported were 1 in the placebo group and 2, 1, 1, 0, and 5 across the dose groups. A total of 0 placebo participants withdrew from the study due to adverse events, compared to 1, 2, 0, 0, and 2 participants in the WVE-120101 groups. The reported data also shows measurements of how much of the drug appeared in the bloodstream and how quickly. The peak blood concentration of WVE-120101 ranged from approximately 7.70 ng/mL (nanograms per millilitre, a measure of drug level in the blood) in the lowest dose group up to 229.01 ng/mL in the highest dose group. The time it took to reach that peak concentration ranged from about 1.34 hours in the lowest dose group to 4.61 hours in the highest dose group. Some additional measurements for repeated dosing were partially reported, but full data for all groups across all time points was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Huntington's Disease Trial, Terminated

NCT03225833
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been pre-screened and found to have a specific genetic marker linked to the Huntington's disease (HD) gene mutation (confirm with trial site)
  • You are male or female, aged between 25 and 65 years old, and are able to walk
  • You have been clinically diagnosed with Huntington's disease based on a standard HD assessment tool, with a confirmed diagnosis score
  • You are in the early stages of HD (Stage I or Stage II), meaning you still have a relatively good level of daily functioning as measured by a standard HD scale

Who may not be able to join:

  • You have had cancer, or received cancer treatment, in the last 5 years (note: previously treated minor skin cancers may be an exception — confirm with trial site)
  • You have taken part in another clinical trial drug study in the past 3 months, or received a specific type of experimental drug called an oligonucleotide in the past 6 months or longer
  • You have a significant ongoing medical condition, unstable mental health symptoms, a substance abuse problem, or are pregnant
  • You are unable to have a brain MRI scan for any reason
  • You have a condition affecting your bones, spine, or blood clotting, or anything else that could make a lumbar puncture (spinal fluid sample) risky or difficult

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, MD, Wave Life Sciences

Australian sites

Westmead Hospital, Sydney, New South Wales
Royal Brisbane & Women's Hospital, Herston, Queensland
Royal Melbourne Hospital, Carlton, Victoria
Monash Health, Clayton, Victoria
Alfred Health, Melbourne, Victoria
Calvary Health Care Bethlehem, Parkdale, Victoria
North Metropolitan Health Service, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Wave Life Sciences USA, Inc.
Registry
ClinicalTrials.gov
Start date
17 July 2017
Est. completion
11 May 2021

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇵🇱 Poland 🇬🇧 United Kingdom

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs); Safety: Severity of Adverse Events; Safety: Number of Patients With Serious TEAEs; Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov