A Phase 2 interventional study of Metyrosine and Placebo in Velo-cardio-facial Syndrome and Psychosis, sponsored by Bausch Health Americas, Inc.. Terminated at 1 site in United States. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-22.
Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment
This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS).
47 studies on the registry are indexed under DiGeorge Syndrome; 10 are open to participants now.
This study's enrollment of 2 is below the median of 28 across 28 interventional studies indexed under DiGeorge Syndrome.
Browse DiGeorge Syndrome studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: Metyrosine
Drug: Placebo
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 capsules were identically matched to Metyrosine.
To Evaluate the Safety of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS
Time frame: 13 weeks
To Evaluate the Efficacy of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS
Time frame: 13 weeks
| Milestone | Metyrosine | Placebo |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metyrosine | — | 0/1 (0%) | 0/1 (0%) |
| Placebo | — | 0/1 (0%) | 0/1 (0%) |
| Age, Customized(participants) | Metyrosine | Placebo | Total |
|---|---|---|---|
| 22 | 1 | 0 | 1 |
| 32 | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Metyrosine | Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 1 | 1 |
| Region of Enrollment(participants) | Metyrosine | Placebo | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.