Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD

NCT02633527 | Completed Phase 2 Results

• 1 other identifier: 812P202
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV)

  The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (never or rarely) to 3 (very often). A Total score is calculated by adding the responses of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). Lower change from baseline scores (\<0) represent a better outcome.

  Baseline to Week 8 (End of Study)

Secondary Outcomes (2)

• Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale

  Week 8 (End of Study)

• Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale

  Baseline to Week 8 (End of Study)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo, qd, oral capsule

Drug: Placebo

100mg SPN-812

EXPERIMENTAL

100mg SPN-812, qd, oral capsule

Drug: 100mg SPN-812

200mg SPN-812

EXPERIMENTAL

200mg SPN-812, qd, oral capsule

Drug: 200mg SPN-812

300mg SPN-812

EXPERIMENTAL

300mg SPN-812, qd, oral capsule

Drug: 300mg SPN-812

400mg SPN-812

EXPERIMENTAL

400mg SPN-812, qd, oral capsule

Drug: 400mg SPN-812

Interventions

Placebo DRUG

Placebo was administered once daily

Also known as: PBO

Placebo

100mg SPN-812 DRUG

100mg SPN-812 was administered once daily and compared to placebo

Also known as: SPN-812, Low Dose

100mg SPN-812

200mg SPN-812 DRUG

200mg SPN-812 was administered once daily and compared to placebo

Also known as: SPN-812, Low-Medium Dose

200mg SPN-812

300mg SPN-812 DRUG

300mg SPN-812 was administered once daily and compared to placebo

Also known as: SPN-812, Medium-High Dose

300mg SPN-812

400mg SPN-812 DRUG

400mg SPN-812 was administered once daily and compared to placebo

Also known as: SPN-812, High Dose

400mg SPN-812

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
• ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
• CGI-S score of at least 4
• Weight of at least 20 kg.
• Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

You may not qualify if:

• Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
• Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
• Significant systemic disease.
• Evidence of suicidality within the six months before Screening or at Screening.
• BMI greater than 95th percentile for the appropriate age and gender.
• Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
• Substance or alcohol use during the last three months.
• Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (1)

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Joseph Hull, PhD, Director Clinical Research
• Organization: Supernus

jhull@supernus.com

240-403-5324

Study Officials

• Joseph T. Hull, PhD

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: February 1, 2016
• Primary Completion: July 25, 2016
• Study Completion: July 25, 2016
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2020-08

Locations

US (1)