Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01795859




Registration number
NCT01795859
Ethics application status
Date submitted
20/02/2013
Date registered
21/02/2013
Date last updated
20/09/2017

Titles & IDs
Public title
First Time Use of SD-809 in Huntington Disease
Scientific title
A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Secondary ID [1] 0 0
SD-809-C-15
Universal Trial Number (UTN)
Trial acronym
First-HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chorea 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SD-809
Treatment: Drugs - Placebo

Experimental: SD-809 ER Tablets - SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.

Experimental: SD-809 Tablets - SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.


Treatment: Drugs: SD-809
SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).

Treatment: Drugs: Placebo
Placebo tablets are identical in appearance to SD-809 tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Timepoint [1] 0 0
Screening, Day 0, Weeks 9, 12
Secondary outcome [1] 0 0
Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
Timepoint [3] 0 0
Baseline, 12 weeks
Secondary outcome [4] 0 0
Change in Berg Balance Test (BBT)
Timepoint [4] 0 0
Baseline, 12 weeks

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/12/2014
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 144 - Kew Vic
Recruitment hospital [2] 0 0
Teva Investigational Site 054 - Sydney
Recruitment postcode(s) [1] 0 0
- Kew Vic
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Vermont
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Canada
State/province [28] 0 0
Montreal
Country [29] 0 0
Canada
State/province [29] 0 0
North York
Country [30] 0 0
Canada
State/province [30] 0 0
Ottawa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01795859