Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)

Supernus Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Attention-Deficit/Hyperactivity Disorder

Treatments: Drug: SPN-812

Study type: Interventional

Funder types: Industry

Identifiers

NCT02736656

812P310

Details and patient eligibility

About

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

Full description

This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 in pediatric subjects with ADHD (A) who completed a Phase 2 (812P202: children 6 to 12 years of age) or one of four Phase 3 trials (812P301/812P303: children 6 to 11 years of age; 812P302/812P304: adolescents 12 to 17 years of age) or (B) who complete a Phase 4 trial (812P401). The study is divided into two phases, Optimization and Maintenance phases. Subjects in Cohort 'A' who completed a Phase 2 or Phase 3 trial followed protocol Schedule 'A' (exposure up to 72 months). Subjects in Cohort 'B' who complete the Phase 4 trial will follow Schedule 'B' (exposure up to 24 months).

Enrollment: 1,400 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

3. Weight of at least ≥5th percentile for age and sex if 4 to 5 years old, at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older.

4. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); and written Informed Assent obtained from the subject if appropriate; written informed consent obtained from the subject if he/she is 18 years old.

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, 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 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 subject 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. Body Mass Index (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 female subjects of childbearing potential (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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 1 patient group

Open-Label Treatment

Experimental group

Description:

Cohort 'A' Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 (100 mg capsule). Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 (100, 200 mg capsule). Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months. Cohort 'B' Subjects 4-5 yrs of age will be treated with 100 mg SPN-812 (100 mg capsule). Subjects may participate for up to 24 months.

Treatment:

Drug: SPN-812