Phase 3 Huntington's Disease Trial, Completed NCT01795859 Sponsor: Teva Branded Pharmaceutical Products R&D, 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 (NCT01795859) involved 90 people in total — 45 who received a tablet called SD-809 and 45 who received a placebo (a dummy tablet with no active ingredient). Nearly all participants finished the trial: 44 in the SD-809 group and 43 in the placebo group. The trial was measuring changes in involuntary movements (called chorea) in people with Huntington's disease, using a scoring system called the Total Maximal Chorea (TMC) scale, which runs from 0 to 28, where a lower score means fewer involuntary movements. The reported data shows that, on the primary measure, the SD-809 group's TMC score decreased by an average of 4.42 points from their starting score, while the placebo group's score decreased by an average of 1.93 points. For the secondary measures, participants were also asked to rate their own overall change (called the Patient Global Impression of Change, or PGIC) — 23 out of 45 people in the SD-809 group rated themselves as "much" or "very much" improved, compared with 9 out of 45 in the placebo group. Clinicians made a similar assessment (called the CGIC) — 19 out of 45 in the SD-809 group were rated as much or very much improved, versus 6 out of 45 in the placebo group. On a physical functioning quality-of-life questionnaire (SF-36, scored 0–100 where higher means less disability), the SD-809 group's score changed by +0.74 points and the placebo group's by −3.61 points. On a balance test scored 0–56 (higher meaning better balance), the SD-809 group's score changed by +2.2 points and the placebo group's by +1.3 points. 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 3 Huntington's Disease Trial, Completed

NCT01795859
Completed Phase 3 🇦🇺 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 must be at least 18 years old (or the legal age of adulthood, whichever is older) at the time of screening.
  • You must have been diagnosed with Huntington's Disease (HD).
  • You must be able to swallow the study medication whole.
  • If you are a woman who could become pregnant, you must agree to use an acceptable form of birth control from the start of the study until it is completed.
  • You must have a reliable caregiver who sees you every day, helps manage your medication, makes sure you attend study appointments, and takes part in evaluations as needed.
  • You must be able to walk at least 20 yards on your own, though using a walker or cane is allowed.

Who may not be able to join:

  • You have a serious psychiatric condition, such as depression, that is not being treated or not being treated well enough.
  • You are currently having thoughts of suicide at the time of screening or at the start of the study.
  • You have a history of suicidal behaviour at the time of screening or at the start of the study.
  • You show signs of depression at the time of screening or at the start of the study.
  • You have an unstable or serious medical or mental health condition at the time of screening or at the start of the study.
  • You have recently taken a medication called tetrabenazine.
  • You have taken any of the following medications within 30 days before screening: antipsychotics, metoclopramide, MAO inhibitors, levodopa or dopamine-boosting drugs, reserpine, amantadine, or memantine.
  • You have serious difficulty swallowing at the time of screening.
  • You have serious difficulty speaking at the time of screening.
  • You need to take medications known to affect heart rhythm in a specific way (prolonging the QT interval).
  • A heart test (ECG) shows an abnormal heart rhythm pattern called a prolonged QT interval.
  • Your liver is not functioning properly at the time of screening.
  • Your kidneys are not functioning properly at the time of screening.
  • You have a known allergy to any ingredient in the study medication.
  • You have taken part in another clinical trial involving an experimental drug or device within 30 days (or 5 drug half-lives, whichever is longer) before screening.
  • You are pregnant or breastfeeding at the time of screening or at the start of the study.
  • You are currently using illegal drugs at the time of screening.
  • You have had a problem with alcohol or drug misuse in the past 12 months.

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 3: approximately ~65% 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

Australian sites

Teva Investigational Site 144, Kew Vic,
Teva Investigational Site 054, Sydney,

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Registry
ClinicalTrials.gov
Start date
5 August 2013
Est. completion
5 December 2014

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇺🇸 United States

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

Primary endpoints

Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12

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