A Phase 3 interventional study of SD-809 and Placebo in Chorea, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 43 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.
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.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's enrollment of 90 is above the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Compared within Huntington Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chorea. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: SD-809 · Drug: 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.
Drug: SD-809 · Drug: 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).
Also known as: deutetrabenazine
Placebo tablets are identical in appearance to SD-809 tablets.
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
Time frame: Screening, Day 0, Weeks 9, 12
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
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
A total of 90 subjects were randomized 1:1 to receive either SD-809 or placebo. All subjects were assessed for capacity to provide informed consent and written informed consent was obtained appropriately
| Milestone | SD-809 Tablets | SD-809 Placebo |
|---|---|---|
| Started | 45 | 45 |
| Completed | 44 | 43 |
| Not completed | 1 | 2 |
Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea
| Units on a scale | SD-809 Tablets | SD-809 Placebo |
|---|---|---|
| Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 | -4.42 ± 2.953 | -1.93 ± 2.666 |
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
| Participants | SD-809 Tablets | SD-809 Placebo |
|---|---|---|
| Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) | 23 | 9 |
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.
| Participants | SD-809 Tablets | SD-809 Placebo |
|---|---|---|
| Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) | 19 | 6 |
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.
| units on a scale | SD-809 Tablets | SD-809 Placebo |
|---|---|---|
| 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 ± 9.773 | -3.61 ± 9.669 |
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.
| units on a scale | SD-809 Tablets | SD-809 Placebo |
|---|---|---|
| Change in Berg Balance Test (BBT) | 2.2 ± 3.47 | 1.3 ± 4.04 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/45 (2.2%) | 21/45 (46.7%) |
| SD-809 | — | 1/45 (2.2%) | 18/45 (40%) |
| Event | Placebo | SD-809 |
|---|---|---|
| Cholecystitis chronicHepatobiliary disorders | 0/45 | 1/45 |
| Agitated depressionPsychiatric disorders | 0/45 | 1/45 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/45 | 0/45 |
| Event | Placebo | SD-809 |
|---|---|---|
| IrritabilityGeneral disorders | 6/45 | 3/45 |
| SomnolenceNervous system disorders | 2/45 | 5/45 |
| DiarrhoeaGastrointestinal disorders | 0/45 | 4/45 |
| Dry mouthGastrointestinal disorders | 3/45 | 4/45 |
| FallInjury, poisoning and procedural complications | 4/45 | 2/45 |
| DizzinessNervous system disorders | 4/45 | 2/45 |
| VomitingGastrointestinal disorders | 3/45 | 0/45 |
| FatigueGeneral disorders | 2/45 | 3/45 |
| HeadacheNervous system disorders | 3/45 | 0/45 |
| DepressionPsychiatric disorders | 3/45 | 1/45 |
| Age, Customized(participants) | SD-809 Tablets | SD-809 Placebo | Total |
|---|---|---|---|
| SD-809 | 55.4 ± 10.32 | 52.1 ± 13.36 | 53.7 ± 11.98 |
| Sex: Female, Male(Participants) | SD-809 Tablets | SD-809 Placebo | Total |
|---|---|---|---|
| Female | 23 | 17 | 40 |
| Male | 22 | 28 | 50 |
| Race (NIH/OMB)(Participants) | SD-809 Tablets | SD-809 Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 5 | 5 |
| White | 45 | 38 | 83 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
Ran from Aug 2013 to primary completion in Dec 2014, 16 months.
Results were first posted in Aug 2017, 2 years 8 months after primary completion. A results delay was requested in Jun 2015.
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Studies of the drug tested here: Deutetrabenazine
Teva Branded Pharmaceutical Products R&D, Inc. →