Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
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|ClinicalTrials.gov Identifier: NCT02633527|
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : October 27, 2021
Last Update Posted : October 27, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Attention-Deficit/Hyperactivity Disorder (ADHD)||Drug: Placebo Drug: 100mg SPN-812 Drug: 200mg SPN-812 Drug: 300mg SPN-812 Drug: 400mg SPN-812||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||July 25, 2016|
|Actual Study Completion Date :||July 25, 2016|
Placebo Comparator: Placebo
Placebo, qd, oral capsule
Placebo was administered once daily
Other Name: PBO
Experimental: 100mg SPN-812
100mg SPN-812, qd, oral capsule
Drug: 100mg SPN-812
100mg SPN-812 was administered once daily and compared to placebo
Other Name: SPN-812, Low Dose
Experimental: 200mg SPN-812
200mg SPN-812, qd, oral capsule
Drug: 200mg SPN-812
200mg SPN-812 was administered once daily and compared to placebo
Other Name: SPN-812, Low-Medium Dose
Experimental: 300mg SPN-812
300mg SPN-812, qd, oral capsule
Drug: 300mg SPN-812
300mg SPN-812 was administered once daily and compared to placebo
Other Name: SPN-812, Medium-High Dose
Experimental: 400mg SPN-812
400mg SPN-812, qd, oral capsule
Drug: 400mg SPN-812
400mg SPN-812 was administered once daily and compared to placebo
Other Name: SPN-812, High Dose
- The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) [ Time Frame: Baseline to Week 8 (End of Study) ]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.
- Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale [ Time Frame: Week 8 (End of Study) ]The first additional secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) Scale score at Week 8 (End of Study). The CGI-I scale is a single item assessment of how much the patient's illness has improved or worsened relative to a baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (<4) in subsequent testing.
- Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale [ Time Frame: Baseline to Week 8 (End of Study) ]The second additional secondary endpoint was the change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale score at Week 8 (End of Study). The CGI-S scale is a single item clinician/investigator rating of the clinician's assessment of the severity of the ADHD symptoms in relation to the clinician's total experience with patients with ADHD. The CGI-S was rated on a 7-point Likert scale, where 1 = Normal, not at all ill, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Extremely Ill. Successful therapy is indicated by a lower CGI-S score in subsequent testing. A lower change from baseline score (<0) represents a better outcome.
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|Ages Eligible for Study:||6 Years to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633527
|United States, Florida|
|Florida Clinical Research Center, LLC|
|Maitland, Florida, United States, 32751|
|Study Director:||Joseph T. Hull, PhD||Supernus Pharmaceuticals, Inc.|
|Responsible Party:||Supernus Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 17, 2015 Key Record Dates|
|Results First Posted:||October 27, 2021|
|Last Update Posted:||October 27, 2021|
|Last Verified:||August 2020|
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders