Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01416064 | Open-Label, Extension Study to 810P202 | PHASE2 | COMPLETED | 78 | — | — | Sep 1, 2011 | Feb 1, 2013 | May 2, 2017 | 28 | United States |
Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS)
| Arm | Type | Description |
|---|---|---|
| Molindone | OTHER | Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion. |
| Name | Type | Description |
|---|---|---|
| Molindone | DRUG | The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion. |
Inclusion Criteria: 1. Successful completion of the 810P202 study. 2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). 3. Weight of at least 20kg. 4. Able and willing to swallow tablets whole and not chewed, cut or crushed...