The trial is taking place at:
E

Evolution Research Group | Woodland International Research Group

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

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

Full 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of a previous double-blind study of SPN-812 for the treatment of ADHD.
  • Continues to be medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms.
  • Weight of at least 20 kg if 6-11 years old and at least 35 kg for subjects aged 12 years and up.
  • Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate.

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:

  • simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
  • surgically sterile male partner
  • simultaneous use of male condom and diaphragm with spermicide
  • established hormonal contraceptive

Exclusion criteria

  • 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.
  • Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).
  • BMI greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls).
  • Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP.
  • Current substance or alcohol use.
  • 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)

1,200 participants in 1 patient group

Open-Label Treatment
Experimental group
Description:
Subjects 6-11 yrs of age will be treated with 100 to 400 mg SPN-812 ER (100 mg capsule). Subjects 12-17 yrs of age will be treated with 100 to 600 mg SPN-812 ER (100, 200 mg capsule). Subjects are given a choice to extend their participation in the study every 6 months for up to 72 months.
Treatment:
Drug: SPN-812

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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