Open-Label, Extension Study to 810P202

Supernus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Impulsive Aggression Comorbid With ADHD in Children

Treatments: Drug: Molindone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416064

810P203

Details and patient eligibility

About

Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).

Enrollment: 78 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.
5. Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.

Exclusion criteria

1. Body Mass Index (BMI) in 97th percentile or above.
2. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

78 participants in 1 patient group

Molindone

Other group

Description:

Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion.

Treatment:

Drug: Molindone