Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Molindone · 1 trial · 1 indication
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...
Molindone is an investigational small molecule being studied for the treatment of impulsive aggression comorbid with ADHD in children. It is in Phase 2 clinical development and is not approved by the FDA. The drug is being developed by Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN).
Molindone is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SUPN. The company is conducting clinical research to evaluate the drug's potential in pediatric psychiatry, specifically for impulsive aggression comorbid with ADHD in children.
Molindone is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied for safety and efficacy. The drug is being evaluated for the treatment of impulsive aggression comorbid with ADHD in children.
Molindone has one completed Phase 2 clinical trial, identified as NCT01416064. This was an open-label, extension study that enrolled 78 participants aged 6 years and older in the United States. The trial was uncontrolled and studied the drug's effects in children with impulsive aggression comorbid with ADHD.
Molindone is a distinct investigational drug being developed specifically for impulsive aggression comorbid with ADHD in children. It is not described as being the same as any other marketed ADHD treatment. Its development is focused on addressing this specific comorbid condition in the pediatric population.