Clinical trial NCT01795859: First Time Use of SD-809 in Huntington Disease
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chorea
Keywords: Huntington disease
Chorea
Tetrabenazine
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12
timeFrame: Screening, Day 0, Weeks 9, 12
Secondary outcomes:
measure: Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)
timeFrame: 12 weeks
measure: Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)
timeFrame: 12 weeks
measure: Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12
timeFrame: Baseline, 12 weeks
measure: Change in Berg Balance Test (BBT)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 057
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 038
state: Arizona
city: Fayetteville
country: United States
facility: Teva Investigational Site 298
state: Arkansas
city: Los Angeles
country: United States
facility: Teva Investigational Site 050
state: California
city: Englewood
country: United States
facility: Teva Investigational Site 052
state: Colorado
city: Washington, D.C.
country: United States
facility: Teva Investigational Site 333
state: District of Columbia
city: Boca Raton
country: United States
facility: Teva Investigational Site 196
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 160
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 014
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 032
state: Georgia
city: Indianapolis
country: United States
facility: Teva Investigational Site 045
state: Indiana
city: Iowa City
country: United States
facility: Teva Investigational Site 024
state: Iowa
city: Kansas City
country: United States
facility: Teva Investigational Site 029
state: Kansas
city: Wichita
country: United States
facility: Teva Investigational Site 083
state: Kansas
city: Louisville
country: United States
facility: Teva Investigational Site 087
state: Kentucky
city: Baltimore
country: United States
facility: Teva Investigational Site 028
state: Maryland
city: Boston
country: United States
facility: Teva Investigational Site 040
state: Massachusetts
city: Saint Louis
country: United States
facility: Teva Investigational Site 027
state: Missouri
city: Las Vegas
country: United States
facility: Teva Investigational Site 194
state: Nevada
city: Camden
country: United States
facility: Teva Investigational Site 328
state: New Jersey
city: New Brunswick
country: United States
facility: Teva Investigational Site 026
state: New Jersey
city: Albany
country: United States
facility: Teva Investigational Site 037
state: New York
city: New York
country: United States
facility: Teva Investigational Site 002
state: New York
city: Patchogue
country: United States
facility: Teva Investigational Site 342
state: New York
city: Durham
country: United States
facility: Teva Investigational Site 119
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 089
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 020
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 093
state: Ohio
city: Tulsa
country: United States
facility: Teva Investigational Site 341
state: Oklahoma
city: Nashville
country: United States
facility: Teva Investigational Site 031
state: Tennessee
city: Houston
country: United States
facility: Teva Investigational Site 007
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 199
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 100
state: Utah
city: Burlington
country: United States
facility: Teva Investigational Site 137
state: Vermont
city: Kirkland
country: United States
facility: Teva Investigational Site 220
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 096
state: Washington
city: Milwaukee
country: United States
facility: Teva Investigational Site 104
state: Wisconsin
city: Kew Vic
country: Australia
facility: Teva Investigational Site 144
city: Sydney
country: Australia
facility: Teva Investigational Site 054
city: Montreal
country: Canada
facility: Teva Investigational Site 098
city: North York
country: Canada
facility: Teva Investigational Site 300
city: Ottawa
country: Canada
facility: Teva Investigational Site 231
city: Ottawa
country: Canada
facility: Teva Investigational Site 300
Study officials:
References:
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.
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.
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.