Trial Outcomes & Findings for Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome (NCT NCT01127503)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

13 weeks

Results posted on

2019-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Metyrosine Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day \[2000 mg/day if metyrosine\]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).	Placebo Placebo: Placebo capsules were identically matched to Metyrosine.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metyrosine n=1 Participants Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day \[2000 mg/day if metyrosine\]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).	Placebo n=1 Participants Placebo: Placebo capsules were identically matched to Metyrosine.	Total n=2 Participants Total of all reporting groups
Age, Customized 22	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Age, Customized 32	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: The study was terminated early and no data was collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 weeks

Population: The study was terminated early and no data was collected

Outcome measures

Outcome data not reported

Adverse Events

Metyrosine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Johnson Varughese

Valeant Pharmaceuticals

Phone: 9089271400

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place