Trial Outcomes & Findings for Ecopipam Treatment of Tourette Syndrome (NCT NCT01244633)

Results Overview

The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

8 weeks

Results posted on

2015-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Ecopipam Active treatment Ecopipam: 50 or 100 mg tablets given once per day for eight weeks
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ecopipam Treatment of Tourette Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ecopipam n=18 Participants Active treatment Ecopipam: 50 or 100 mg tablets given once per day for eight weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Subjects completing the study

The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.

Outcome measures

Outcome measures
Measure	Ecopipam n=15 Participants Active treatment Ecopipam: 50 or 100 mg tablets given once per day for eight weeks
Yale Global Tic Severity Score	25.3 units on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Every 7 days

This is a standard measure of ADHD severity that is typically used in these types of clinical trials.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 7 days

This is a measure of feelings of depression that the patient might have.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 7 days

This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of trial

This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 7 days

Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 7 days

This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.

Outcome measures

Outcome data not reported

Adverse Events

Ecopipam

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ecopipam n=18 participants at risk Active treatment Ecopipam: 50 or 100 mg tablets given once per day for eight weeks
Nervous system disorders Insomnia	33.3% 6/18 • 8 weeks

Additional Information

Dr. Richard Chipkin

Psyadon Pharmaceuticals

Phone: 3019192020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place