Phase 3
Completed N=90
First Time Use of SD-809 in Huntington Disease
Source: ClinicalTrials.gov NCT01795859 ↗Enrolled (actual)
90
Serious AEs
2.2%
Results posted
Aug 2017
Primary outcomePrimary: Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 — -4.42; -1.93 Units on a scale — p=<0.0001
◆ Published Evidence
Highly cited
398citations · ~40 / year
Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial.
Summary
The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.
Linked Publications (5)
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Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial.
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Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease.
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Huntington’s Disease Clinical Trials Corner: February 2018
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Safety and Efficacy of Deutetrabenazine at High versus Lower Daily Dosages in the ARC-HD Study to Treat Chorea in Huntington Disease.
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Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 |
-4.42; -1.93 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) |
23; 9 | 0.0020 sig |
| SECONDARY Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) |
19; 6 | 0.0022 sig |
| SECONDARY Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 |
0.74; -3.61 | 0.0308 sig |
| SECONDARY Change in Berg Balance Test (BBT) |
2.2; 1.3 | 0.1415 |
Eligibility Criteria
Inclusion Criteria
- Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
- Subject has been diagnosed with manifest HD
- Subject is able to swallow study medication whole.
- Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
- The subject has a reliable caregiver who interacts with the patient on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
- Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) is permitted during ambulation).
Exclusion Criteria
- Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
- Subject has active suicidal ideation at Screening or Baseline.
- Subject has history of suicidal behavior at Screening or Baseline:
- Subject has evidence for depression at Screening or Baseline.
- Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
- Subject has been recently exposed to tetrabenazine.
- Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:
- Antipsychotics
- Metoclopramide
- Monoamine oxidase inhibitors (MAOI)
- Levodopa or dopamine agonists
- Reserpine
- Amantadine
- Memantine
- Subject has significantly impaired swallowing function at Screening.
- Subject has significantly impaired speaking at Screening.
- Subject requires treatment with drugs known to prolong the QT interval.
- Subject has a prolonged QT interval on 12-lead ECG at Screening.
- Subject has evidence of hepatic impairment at Screening.
- Subject has evidence of significant renal impairment at Screening.
- Subject has known allergy to any of the components of study medication.
- Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
- Subject is pregnant or breast-feeding at Screening or Baseline.
- Subject acknowledges present use of illicit drugs at Screening.
- Subject has a history of alcohol or substance abuse in the previous 12 months.
Data sourced from ClinicalTrials.gov (NCT01795859) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.