Trial Outcomes & Findings for First Time Use of SD-809 in Huntington Disease (NCT NCT01795859)

NCT ID: NCT01795859

Last Updated: 2017-09-20

Results Overview

Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 90 participants
• Primary outcome timeframe: Screening, Day 0, Weeks 9, 12
• Results posted on: 2017-09-20

Participant Flow

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

Participant milestones

Measure	SD-809 Tablets 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).	SD-809 Placebo Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Overall Study STARTED	45	45
Overall Study COMPLETED	44	43
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First Time Use of SD-809 in Huntington Disease

Baseline characteristics by cohort

Measure	SD-809 Tablets n=45 Participants 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).	SD-809 Placebo n=45 Participants Placebo: Placebo tablets are identical in appearance to SD-809 tablets.	Total n=90 Participants Total of all reporting groups
Age, Customized SD-809	55.4 participants STANDARD_DEVIATION 10.32 • n=5 Participants	52.1 participants STANDARD_DEVIATION 13.36 • n=7 Participants	53.7 participants STANDARD_DEVIATION 11.98 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	38 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, Day 0, Weeks 9, 12

Population: 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

Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea

Outcome measures

Measure	SD-809 Tablets n=45 Participants 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).	SD-809 Placebo n=45 Participants Placebo: 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	-4.42 Units on a scale Standard Deviation 2.953	-1.93 Units on a scale Standard Deviation 2.666

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Measure	SD-809 Tablets n=45 Participants 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).	SD-809 Placebo n=45 Participants Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)	23 Participants	9 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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.

Outcome measures

Measure	SD-809 Tablets n=45 Participants 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).	SD-809 Placebo n=45 Participants Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)	19 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: 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

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.

Outcome measures

Measure	SD-809 Tablets n=45 Participants 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).	SD-809 Placebo n=43 Participants Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
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 units on a scale Standard Deviation 9.773	-3.61 units on a scale Standard Deviation 9.669

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: 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

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.

Outcome measures

Measure	SD-809 Tablets n=45 Participants 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).	SD-809 Placebo n=45 Participants Placebo: Placebo tablets are identical in appearance to SD-809 tablets.
Change in Berg Balance Test (BBT)	2.2 units on a scale Standard Deviation 3.47	1.3 units on a scale Standard Deviation 4.04

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

SD-809

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=45 participants at risk Placebo	SD-809 n=45 participants at risk SD-809
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/45	2.2% 1/45 • Number of events 1
Psychiatric disorders Agitated depression	0.00% 0/45	2.2% 1/45 • Number of events 1
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.2% 1/45 • Number of events 1	0.00% 0/45

Other adverse events

Measure	Placebo n=45 participants at risk Placebo	SD-809 n=45 participants at risk SD-809
Gastrointestinal disorders Diarrhoea	0.00% 0/45	8.9% 4/45 • Number of events 4
Gastrointestinal disorders Dry mouth	6.7% 3/45 • Number of events 3	8.9% 4/45 • Number of events 4
Gastrointestinal disorders Vomiting	6.7% 3/45 • Number of events 3	0.00% 0/45
General disorders Fatigue	4.4% 2/45 • Number of events 2	6.7% 3/45 • Number of events 4
General disorders Irritability	13.3% 6/45 • Number of events 6	6.7% 3/45 • Number of events 3
Injury, poisoning and procedural complications Fall	8.9% 4/45 • Number of events 6	4.4% 2/45 • Number of events 4
Nervous system disorders Dizziness	8.9% 4/45 • Number of events 4	4.4% 2/45 • Number of events 2
Nervous system disorders Headache	6.7% 3/45 • Number of events 3	0.00% 0/45
Nervous system disorders Somnolence	4.4% 2/45 • Number of events 2	11.1% 5/45 • Number of events 6
Psychiatric disorders Depression	6.7% 3/45 • Number of events 3	2.2% 1/45 • Number of events 1
Psychiatric disorders Insomnia	4.4% 2/45 • Number of events 2	6.7% 3/45 • Number of events 3
Psychiatric disorders Sleep disorder	6.7% 3/45 • Number of events 3	0.00% 0/45

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products R&D, Inc.

Phone: 215-591-3000

Email: ustevatrials@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60