Trial Outcomes & Findings for An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. (NCT NCT00206336)

Results Overview

A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

baseline to Day 70

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Topiramate Topiramate open label Topiramate (drug): Topiramate 25 mg to 200 mg
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate n=20 Participants Topiramate open label Topiramate (drug): Topiramate 25 mg to 200 mg
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.5 years STANDARD_DEVIATION 9.89 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to Day 70

A component of the Yale Global Tic Severity Scale (YGTSS), the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the pre-defined primary endpoint. The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment).

Outcome measures

Outcome measures
Measure	Topiramate n=20 Participants Topiramate open label Topiramate (drug): Topiramate 25 mg to 200 mg
Change in TTS	-14.29 units on a scale Standard Deviation 10.47

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Topiramate n=20 participants at risk Topiramate open label Topiramate (drug): Topiramate 25 mg to 200 mg
General disorders headache	15.0% 3/20 • Number of events 3
General disorders cognitive slowing	5.0% 1/20 • Number of events 1

Additional Information

Dr. Joseph Jankovic

Baylor College of Medicine

Phone: 713-798-6556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place