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First Time Use of SD-809 in Huntington Disease (First-HD)

Primary Purpose

Chorea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SD-809
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorea focused on measuring Huntington disease, Chorea, Tetrabenazine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teva Investigational Site 057
  • Teva Investigational Site 038
  • Teva Investigational Site 298
  • Teva Investigational Site 050
  • Teva Investigational Site 052
  • Teva Investigational Site 333
  • Teva Investigational Site 196
  • Teva Investigational Site 160
  • Teva Investigational Site 014
  • Teva Investigational Site 032
  • Teva Investigational Site 045
  • Teva Investigational Site 024
  • Teva Investigational Site 029
  • Teva Investigational Site 083
  • Teva Investigational Site 087
  • Teva Investigational Site 028
  • Teva Investigational Site 040
  • Teva Investigational Site 027
  • Teva Investigational Site 194
  • Teva Investigational Site 328
  • Teva Investigational Site 026
  • Teva Investigational Site 037
  • Teva Investigational Site 002
  • Teva Investigational Site 342
  • Teva Investigational Site 119
  • Teva Investigational Site 089
  • Teva Investigational Site 020
  • Teva Investigational Site 093
  • Teva Investigational Site 341
  • Teva Investigational Site 031
  • Teva Investigational Site 007
  • Teva Investigational Site 199
  • Teva Investigational Site 100
  • Teva Investigational Site 137
  • Teva Investigational Site 220
  • Teva Investigational Site 096
  • Teva Investigational Site 104
  • Teva Investigational Site 144
  • Teva Investigational Site 054
  • Teva Investigational Site 098
  • Teva Investigational Site 300
  • Teva Investigational Site 231
  • Teva Investigational Site 300

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SD-809 ER Tablets

SD-809 Tablets

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea

Secondary Outcome Measures

Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.
Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in Berg Balance Test (BBT)
The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.

Full Information

First Posted
February 20, 2013
Last Updated
August 22, 2017
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01795859
Brief Title
First Time Use of SD-809 in Huntington Disease
Acronym
First-HD
Official Title
A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 5, 2013 (Actual)
Primary Completion Date
December 5, 2014 (Actual)
Study Completion Date
December 5, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorea
Keywords
Huntington disease, Chorea, Tetrabenazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SD-809 ER Tablets
Arm Type
Experimental
Arm Description
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.
Arm Title
SD-809 Tablets
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SD-809
Other Intervention Name(s)
deutetrabenazine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets are identical in appearance to SD-809 tablets.
Primary Outcome Measure Information:
Title
Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
Description
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
Time Frame
Screening, Day 0, Weeks 9, 12
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
Description
A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
Time Frame
12 weeks
Title
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
Description
A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.
Time Frame
12 weeks
Title
Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
Description
Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Baseline, 12 weeks
Title
Change in Berg Balance Test (BBT)
Description
The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Teva Investigational Site 057
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 038
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 298
City
Fayetteville
State/Province
Arkansas
Country
United States
Facility Name
Teva Investigational Site 050
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 052
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 333
City
Washington, D.C.
State/Province
District of Columbia
Country
United States
Facility Name
Teva Investigational Site 196
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 160
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 014
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 032
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 045
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Teva Investigational Site 024
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Teva Investigational Site 029
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Teva Investigational Site 083
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Teva Investigational Site 087
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Teva Investigational Site 028
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 040
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 027
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 194
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Teva Investigational Site 328
City
Camden
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 026
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 037
City
Albany
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 002
City
New York
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 342
City
Patchogue
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 119
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 089
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 020
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 093
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 341
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 031
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 007
City
Houston
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 199
City
Houston
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 100
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 137
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Teva Investigational Site 220
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 096
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 104
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Teva Investigational Site 144
City
Kew Vic
Country
Australia
Facility Name
Teva Investigational Site 054
City
Sydney
Country
Australia
Facility Name
Teva Investigational Site 098
City
Montreal
Country
Canada
Facility Name
Teva Investigational Site 300
City
North York
Country
Canada
Facility Name
Teva Investigational Site 231
City
Ottawa
Country
Canada
Facility Name
Teva Investigational Site 300
City
Ottawa
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29480210
Citation
Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001.
Results Reference
derived
PubMed Identifier
28265459
Citation
Claassen DO, Carroll B, De Boer LM, Wu E, Ayyagari R, Gandhi S, Stamler D. Indirect tolerability comparison of Deutetrabenazine and Tetrabenazine for Huntington disease. J Clin Mov Disord. 2017 Mar 1;4:3. doi: 10.1186/s40734-017-0051-5. eCollection 2017.
Results Reference
derived
PubMed Identifier
27380342
Citation
Huntington Study Group; Frank S, Testa CM, Stamler D, Kayson E, Davis C, Edmondson MC, Kinel S, Leavitt B, Oakes D, O'Neill C, Vaughan C, Goldstein J, Herzog M, Snively V, Whaley J, Wong C, Suter G, Jankovic J, Jimenez-Shahed J, Hunter C, Claassen DO, Roman OC, Sung V, Smith J, Janicki S, Clouse R, Saint-Hilaire M, Hohler A, Turpin D, James RC, Rodriguez R, Rizer K, Anderson KE, Heller H, Carlson A, Criswell S, Racette BA, Revilla FJ, Nucifora F Jr, Margolis RL, Ong M, Mendis T, Mendis N, Singer C, Quesada M, Paulsen JS, Brashers-Krug T, Miller A, Kerr J, Dubinsky RM, Gray C, Factor SA, Sperin E, Molho E, Eglow M, Evans S, Kumar R, Reeves C, Samii A, Chouinard S, Beland M, Scott BL, Hickey PT, Esmail S, Fung WL, Gibbons C, Qi L, Colcher A, Hackmyer C, McGarry A, Klos K, Gudesblatt M, Fafard L, Graffitti L, Schneider DP, Dhall R, Wojcieszek JM, LaFaver K, Duker A, Neefus E, Wilson-Perez H, Shprecher D, Wall P, Blindauer KA, Wheeler L, Boyd JT, Houston E, Farbman ES, Agarwal P, Eberly SW, Watts A, Tariot PN, Feigin A, Evans S, Beck C, Orme C, Edicola J, Christopher E. Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):40-50. doi: 10.1001/jama.2016.8655.
Results Reference
derived

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First Time Use of SD-809 in Huntington Disease

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