Trial Outcomes & Findings for Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease (NCT NCT01451463)

Results Overview

The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for \>18 hours with the performance two hours after resuming tetrabenazine was made.

Recruitment status

COMPLETED

Target enrollment

11 participants

Primary outcome timeframe

>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

Results posted on

2017-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	Individuals on Stable Doses of Tetrabenazine Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Xenazine(Tetrabenazine)on Gait and Functional Activity in Individuals With Huntington's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individuals on Stable Doses of Tetrabenazine n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied while off medication and then following resumption of medication.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	52.2 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for \>18 hours with the performance two hours after resuming tetrabenazine was made.

Outcome measures

Outcome measures
Measure	Individuals 2 Hours After Resuming Tetrabenazine n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test following resumption of medication \> 18 hours after being off their regular stable dose of medication.	Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test after being off their stable dose of medication for \> 18 hours
Tinetti Mobility Test Score	19.91 Total Tinetti Mobility Test Score (TMT) Standard Deviation 3.53	17.09 Total Tinetti Mobility Test Score (TMT) Standard Deviation 4.04

SECONDARY outcome

Timeframe: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for \>18 hours to performance 2 hours after resumption of tetrabenazine. Lower time scores are associated with better balance.

Outcome measures

Outcome measures
Measure	Individuals 2 Hours After Resuming Tetrabenazine n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test following resumption of medication \> 18 hours after being off their regular stable dose of medication.	Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test after being off their stable dose of medication for \> 18 hours
Five Times Sit to Stand Test	12.61 seconds to complete 5 sit to stand cycle Standard Deviation 3.00	15.52 seconds to complete 5 sit to stand cycle Standard Deviation 3.81

OTHER_PRE_SPECIFIED outcome

Timeframe: >18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine

The Six Condition Romberg Test is used assess static balance. Subjects are tested standing with their arms crossed over their chests and are assessed for 30 seconds in the following 6 conditions: 1) feet together, 2) feet together eyes closed, 3) feet aligned in tandem heel-to-toe position eyes open, 4) feet aligned in tandem heel-to-toe position eyes closed, 5) standing in tandem position while counting backwards by 3's from 100 with eyes open, 6) standing in tandem position while counting backwards by 3's from 100 with eyes closed. Comparison of performances were made when off stable dose of tetrabenazine for \> 18 hours to performance 2 hours after resumption of tetrabenazine. If a participant could not hold a stance for the full 30 seconds, then that component of the Romberg test ended at that point with the time of that component scored in seconds; 30 seconds being the maximum score for each of the 6 tests. The total score was calculated as a sum of all of the 6 subset scores.

Outcome measures

Outcome measures
Measure	Individuals 2 Hours After Resuming Tetrabenazine n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test following resumption of medication \> 18 hours after being off their regular stable dose of medication.	Individuals Off Their Stable Dose of Tetrabenazine for > 18 hr n=11 Participants 11 Individuals on stable doses of tetrabenazine were studied on the Tinetti Mobility Test after being off their stable dose of medication for \> 18 hours
Six Condition Romberg Test	83.08 Six Condition Romberg Test score Standard Deviation 27.57	73.26 Six Condition Romberg Test score Standard Deviation 16.29

Adverse Events

Individuals on Stable Doses of Tetrabenazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sandra K Kostyk, MD, PhD

The Ohio State University

Phone: 6142934969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place