Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02736656 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 3
Started2016-02-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 15, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-07-13
Study Status, Study Description, Arms and Interventions v9
Study description+81 characters
[...] extended-release capsules) in pediatric subjects with ADHD who completed a randomized, double-blind, placebo-controlled clinical trial, including (A) who completed a Phase 2 (Study 812P202: children 6 to 12 years of age) or one of foura Phase 3 trialstrial (Study 812P301/ or 812P303: children 6 to 11 years of age; or Study 812P302/ or 812P304: adolescents 12 to 17 years of age) or (B) who completed a Phase 4 trial (Study 812P401: preschool-age children, 4-5 years of age). The stud [...]
2025-06-19
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v8
Eligibility criteria+1,220 characters
Cohort 'A' Inclusion/Exclusion Criteria: Inclusion Criteria 'A': Completion of a previous blinded study of SPN-812 for the tr [...] files, vital signs, and electrocardiograms (ECGs). 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 y [...] ed Assent obtained from the subject if appropriate; written informedInformed consentConsent obtained from the subject if he/she is 18 years old. Female [...] micide established hormonal contraceptive Exclusion Criteria 'A': Current diagnosis of significant systemic disease or of a [...] bearing potential [...]
Secondary endpoints2 entries, revised
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV-Preschool, ADHD-RS-IV or ADHD-RS-5) Score
Study description+81 characters
This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 (viloxazine extended-release capsules) in pediatric subjects with ADHD (A) who completed a Phase 2 [...] P302/812P304: adolescents 12 to 17 years of age) or (B) who completecompleted a Phase 4 trial (812P401: preschool-age children, 4-5 years of age). The study is divided into two phases, Optimization and Ma [...] the Phase 4 trial will follow Schedule 'B' (exposure up to 246 months).
2024-07-03
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v7
Primary completion date2025-06→2026-09
Completion date2025-06→2026-09
Enrollment target1200→1400
Eligibility criteria+186 characters
Inclusion Criteria: Completion of a previous double-blindblinded study of SPN-812 for the treatment of ADHD. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). 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 for subjects agedif 12 years andor upolder. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); and written Informed Assent/Consent obtained from the subject if appropriate; written informe [...] [...]
Study description-210 characters
This is a multicenter, open-label extension study aimed to assessassessing 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 with ADHD (A) who have participated incompleted a previousPhase blinded2 study(812P202: children 6 to 12 years of SPN-812age) ERor one of four Phase 3 trials (812P202,812P301/812P303: 812P301,children 6 to 11 years of age; 812P302,/812P304: 812P303,adolescents and12 812P304to 17 years [...] [...]
Study title+16 characters
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Release (ERCapsule)
2023-04-13
Study Status v6
Primary completion date2024-06→2025-06
Completion date2024-06→2025-06
2022-03-04
Study Status, Arms and Interventions v5
InterventionsSPN-812 ER (Drug)→SPN-812 (Drug)
Show 4 earlier versions
2021-03-01
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2021-06→2024-06
Completion date2021-06→2024-06
Eligibility criteria+725 characters
Inclusion Criteria: Completion of a previous blindeddouble-blind study of SPN-812 ER for the treatment of ADHD. Continues to be medically healthy and 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 s [...] [...]
Secondary endpoints2 entries, revised
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or A [...] re Trends in Clinical Global Impression-Improvement (CGI-I) scale score
Study description+61 characters
[...] iatric subjects who have participated in a previous blinded studiesstudy of SPN-812 ER (812P202, 812P301, 812P302, 812P303, and 812P [...] e option to participate in this study in which all subjects will receive SPN-812 ER at an optimized dose. After an initial do [...] mization, subjects will return to the clinic every 3 months for up to 72 months or until the subject discontinues or the studyavailability endsof atSPN 36812 monthson the market, whichever occurs first.
2019-10-09
Recruiting→Active, Not Recruiting Study Status, Outcome Measures, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Secondary endpointsdetails revised at 1 of 2 entries
Study sitesdetails revised at 16 of 16 sites
2018-09-04
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2019-04→2021-06
Completion date2019-04→2021-06
Start date2016-04→2016-02-02
Enrollment target200→1200
Study sites1→16
Eligibility criteriarevised
[...] eting Diagnostic and Statistical Manual of Mental Disorders-V5 criteria for an anxiety disorder as primary diagnosis. Curr [...]
Secondary endpoints2 entries, revised
Trends in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV or ADHD-RS-5) Score Trends in Clinical Global Impression-Improvement (CGI-I) and Clinical Global Impression-Severity (CGI-S) score
Study description+832 characters
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 subje [...]
2016-04-12
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Conditions, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
Eligibility criteria+37 characters
[...] mal laboratory profiles, vital signs, and electrocardiograms (ECGs). Weight of at least 20 kg. Written Informed Consent obtaine [...] om the subject's parent or legally authorized representative (LAR); written Informed Assent obtained from the subject if appro [...] er, or psychosis not otherwise specified. Currently meeting DSMDiagnostic and Statistical Manual of Mental Disorders-V criteria for an anxiety disorder as primary diagnosis. Cu [...]
Study title+19 characters
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 Extended Release (ER)
2016-04-07
Original filing
Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
Trial Details
NCT Number NCT02736656
Lead Sponsor Supernus Pharmaceuticals, Inc.
Conditions Attention-Deficit/Hyperactivity Disorder
Enrollment 1,400 participants
Start Date 2016-02-02
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-15