Trial · NCT01795859
First Time Use of SD-809 in Huntington Disease
NCT01795859, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2017-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First Time Use of SD-809 in Huntington Disease. Trials, record NCT01795859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01795859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First Time Use of SD-809 in Huntington Disease
- NCT number
- NCT01795859
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Chorea
- Interventions
- SD-809, Placebo
- First posted
- 2013-02-21
- Last updated
- 2017-09-20
- Results first posted
- 2017-08-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 | Screening, Day 0, Weeks 9, 12 | Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea |
| Secondary | Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) | 12 weeks | 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 |
| Secondary | Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) | 12 weeks | 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. |
| Secondary | Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 | Baseline, 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. 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. |
| Secondary | Change in Berg Balance Test (BBT) | Baseline, 12 weeks | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 | Screening, Day 0, Weeks 9, 12 | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects who missed both Week 9 or Week 12 scores, the last available assessment was used | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) | 12 weeks | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post baseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) | 12 weeks | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post-baseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 | Baseline, 12 weeks | The modified intent to treat (mITT) population will include all subjects in the ITT population who were randomized to treatment and received study drug. For subjects with missing value at Week 12, the last available assessment was used | units on a scale | MEAN |
| SECONDARY | Change in Berg Balance Test (BBT) | Baseline, 12 weeks | The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects with missing value at Week 12, the last available assessment was used | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 | SD-809 Tablets | -4.42 | Standard Deviation 2.953 | Units on a scale | |
| Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12 | SD-809 Placebo | -1.93 | Standard Deviation 2.666 | Units on a scale | |
| Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) | SD-809 Tablets | 23 | Participants | ||
| Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) | SD-809 Placebo | 9 | Participants | ||
| Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) | SD-809 Tablets | 19 | Participants | ||
| Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) | SD-809 Placebo | 6 | Participants | ||
| Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 | SD-809 Tablets | 0.74 | Standard Deviation 9.773 | units on a scale | |
| Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12 | SD-809 Placebo | -3.61 | Standard Deviation 9.669 | units on a scale | |
| Change in Berg Balance Test (BBT) | SD-809 Tablets | 2.2 | Standard Deviation 3.47 | units on a scale | |
| Change in Berg Balance Test (BBT) | SD-809 Placebo | 1.3 | Standard Deviation 4.04 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SD-809 Tablets | 45 | |
| Overall Study | STARTED | SD-809 Placebo | 45 | |
| Overall Study | COMPLETED | SD-809 Tablets | 44 | |
| Overall Study | COMPLETED | SD-809 Placebo | 43 | |
| Overall Study | NOT COMPLETED | SD-809 Tablets | 1 | |
| Overall Study | NOT COMPLETED | SD-809 Placebo | 2 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | SD-809 | 4 | 45 | 4 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 45 | 3 |
| other | Dry mouth | Gastrointestinal disorders | SD-809 | 4 | 45 | 4 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 45 | 3 |
| other | Vomiting | Gastrointestinal disorders | SD-809 | 0 | 45 | 0 |
| other | Fatigue | General disorders | Placebo | 2 | 45 | 2 |
| other | Fatigue | General disorders | SD-809 | 3 | 45 | 4 |
| other | Irritability | General disorders | Placebo | 6 | 45 | 6 |
| other | Irritability | General disorders | SD-809 | 3 | 45 | 3 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | SD-809 | ||
| Total, other adverse events | Placebo | 21 | 45 |
| Total, other adverse events | SD-809 | 18 | 45 |
| Total, serious adverse events | Placebo | 1 | 45 |
| Total, serious adverse events | SD-809 | 1 | 45 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SD-809 Tablets vs SD-809 Placebo: Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) | Trial comparisons |
| SD-809 Tablets vs SD-809 Placebo: Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC) | Trial comparisons |
| SD-809 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01795859
GET https://conductscience.org/api/trials/v1/NCT01795859/events?page=2