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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01795859 |
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Date of registration:
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20/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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First Time Use of SD-809 in Huntington Disease
First-HD |
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Scientific title:
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A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease |
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Date of first enrolment:
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August 5, 2013 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01795859 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chorea
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Intervention(s)
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Drug: SD-809
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Drug: Placebo
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Primary Outcome(s)
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Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
[Time Frame: Screening, Day 0, Weeks 9, 12]
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Secondary Outcome(s)
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Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
[Time Frame: Baseline, 12 weeks]
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Change in Berg Balance Test (BBT)
[Time Frame: Baseline, 12 weeks]
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Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
[Time Frame: 12 weeks]
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Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
[Time Frame: 12 weeks]
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Secondary ID(s)
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SD-809-C-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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