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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 ER for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02736656
• Other study ID #: 812P310
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2, 2016
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a multicenter, open-label extension study aimed to assess long-term safety and efficacy of SPN-812 ER when administered alone or in conjunction with an Food and Drug Administration-approved Attention Deficit Hyperactivity Disorder (ADHD) medication in the treatment of ADHD in pediatric subjects who have participated in a previous blinded study of SPN-812 ER (812P202, 812P301, 812P302, 812P303, and 812P304). All pediatric subjects who complete a blinded study of SPN-812 ER will have the option to participate in this study in which all subjects will receive SPN-812 ER at an optimized dose. After an initial dose, subjects will enter an dose optimization phase of up to twelve weeks. Following optimization, subjects will return to the clinic every 3 months for up to 72 months or until the subject discontinues or the availability of SPN 812 on the market, whichever occurs first.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• SPN-812

Locations

Country	Name	City	State
United States	Northwest Clinical Trials	Bellevue	Washington
United States	Meridien Research at Florida Clinical Research Center	Bradenton	Florida
United States	Ericksen Research & Development	Clinton	Utah
United States	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	Bayou City Research Corporation	Houston	Texas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Alliance for Wellness dba Alliance for Research	Long Beach	California
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Florida Clinical Research Center, LLC.	Maitland	Florida
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	CNS Healthcare	Memphis	Tennessee
United States	IPS Research	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals	Oklahoma City	Oklahoma
United States	Road Runner Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Change from Baseline	72 months
Secondary	Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score	Change from Baseline in ADHD-RS Total score by visit	ADHD-RS will be administered at baseline and every 3 months for up to 72 months
Secondary	Trends in Clinical Global Impression-Improvement (CGI-I) scale score	CGI-I score by visit	CGI-I will be assessed post-baseline every 3 months for up to 72 months