Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Open label, flexible dose, long-term multicenter study of safety and efficacy of SPN-812 ER in pediatric ADHD patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Completion of a previous double-blind study of SPN-812 for the treatment of ADHD.

2. Continues to be medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms.

3. Weight of at least 20 kg if 6-11 years old and at least 35 kg for subjects aged 12 years and up.

4. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate.

5. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose and throughout the study:

1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration

2. surgically sterile male partner

3. simultaneous use of male condom and diaphragm with spermicide

4. established hormonal contraceptive

Exclusion Criteria:

1. Current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the patient is free of episodes currently and for the last six months.

2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).

3. BMI greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls).

4. Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP.

5. Current substance or alcohol use.

6. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.