Classroom Study of SPN-812 in Children With ADHD

NCT04016792 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 812P308
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, compared to placebo in children in an analog classroom setting.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Efficacy of SPN-812 assessed by Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale- Combined Score (SKAMP-CS)

  Change from baseline in mean SKAMP-CS, averaged from 8 post-dose assessments collected across the 12-h analog classroom day

  29 days

Secondary Outcomes (10)

• Effect of SPN-812 assessed longitudinally by SKAMP-CS

  29 days

• Effect of SPN-812 assessed longitudinally by Permanent Product (PERMP) math test

  29 days

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

  29 days

• Effect of SPN-812 on SKAMP Attention and SKAMP Deportment subscales

  29 days

• Effect of SPN-812 assessed longitudinally on SKAMP Attention and SKAMP Deportment subscales

  29 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo qd

Drug: Placebo

SPN-812

EXPERIMENTAL

200 mg SPN-812

Drug: 200 mg SPN-812

Interventions

Placebo DRUG

Placebo will be administered once daily

Also known as: PBO

Placebo

200 mg SPN-812 DRUG

200 mg SPN-812 will be administered once daily and compared to Placebo

Also known as: SPN-812 Fixed Dose

SPN-812

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects, 6 to \<12 years of age at screening.
• Primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) or ADHD with comorbidity of mild to moderate oppositional defiant disorder (ODD) according to the DSM-5, confirmed with the MINI-KID at screening.
• ADHD-RS-5 (Home Version: Child, Investigator Administered and Scored) score ≥28 at screening and at baseline (can be assessed 1 to 2 days before Visit 3).
• CGI-S score ≥ 4 at baseline (can be assessed 1 to 2 days before Visit 3).
• Body weight ≥ 20 kg.
• Free of medication for the treatment of ADHD for at least 1 week prior to randomization and agreement to remain so throughout participation in the study.
• Have the ability to complete PERMP assessments by qualifying for at least the Basic level at screening (see Section 6.1.2).
• Considered medically healthy by the Investigator via assessment of physical examination, medical and psychiatric histories, clinical laboratory tests, vital signs, and ECG.
• Written informed consent obtained from the subject's parent or legal representative, and written informed assent (if applicable) obtained from the subject.
• Subject and parent(s)/legal guardian(s) are willing and able to comply with all of the procedures and requirements defined in the protocol, including parents(s)/legal guardian(s) oversight of the morning dosing of SM.
• Subject has lived with the same parent(s)/legal guardian(s) for \> 6 months.
• FOCP must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following highly effective contraceptive methods beginning 30 days prior to the first dose, throughout their participation in the study:
• Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to the first SM administration;
• Surgically sterile male partner;
• Simultaneous use of male condom and diaphragm with spermicide;

You may not qualify if:

• Current diagnosis of major psychiatric disorders or intellectual disabilities are excluded, including severe ODD, conduct disorder, autism spectrum disorders, simple phobias, or learning disorders. Subjects with a history of Major Depressive Disorder are eligible if the subject has not experienced an episode or required pharmacotherapy within the 6 months prior to the screening visit.
• Subject has failed two treatment courses (dose and duration) of stimulant or nonstimulant for ADHD; subjects who are treatment naïve are not excluded from participating.
• In the opinion of the investigator, current diagnosis of significant systemic disease.
• Body mass index greater than 95th percentile for the appropriate age and gender.
• At screening, uncontrolled thyroid disorder defined as thyroid stimulating hormone ≤ 0.8 x the lower limit of normal or ≥ 1.25 x the upper limit of normal for the reference laboratory.
• Any clinically significant abnormal laboratory test, urine test, ECG result, or physical exam finding that, in the opinion of the Investigator, would interfere with the safety of the subject.
• Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts within the year prior to screening visit, or a lifetime suicide attempt).
• History of an allergic reaction to viloxazine or its excipients.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
• Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 2 dosing of SM.
• Subjects who participated in previous SPN-812 clinical trials.
• Subjects who have participated in another analog classroom study within 6 months prior to screening visit and subjects who have participated in more than one classroom study.
• Pregnancy, breastfeeding, or refusal to practice abstinence or acceptable birth control during the study (for FOCP).
• Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Subjects currently taking specific concomitant medications known to be CYP1A2 substrates (e.g., theophylline, melatonin, olanzapine, duloxetine).

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefan Schwabe, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: July 10, 2019
• First Posted: July 11, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share