Condition or disease | Intervention/treatment | Phase |
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ADHD | Drug: Placebo Drug: 200 mg SPN-812 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder |
Estimated Study Start Date : | August 2019 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | November 2020 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Placebo qd
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Drug: Placebo
Placebo will be administered once daily
Other Name: PBO
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Experimental: SPN-812
200 mg SPN-812
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Drug: 200 mg SPN-812
200 mg SPN-812 will be administered once daily and compared to Placebo
Other Name: SPN-812 Fixed Dose
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Ages Eligible for Study: | 6 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Study Director: | Stefan Schwabe, MD | Chief Medical Officer |
Tracking Information | |||||
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First Submitted Date ICMJE | July 10, 2019 | ||||
First Posted Date ICMJE | July 11, 2019 | ||||
Last Update Posted Date | September 18, 2019 | ||||
Estimated Study Start Date ICMJE | August 2019 | ||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Efficacy of SPN-812 assessed by Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale- Combined Score (SKAMP-CS) [ Time Frame: 29 days ] Change from baseline in mean SKAMP-CS, averaged from 8 post-dose assessments collected across the 12-h analog classroom day
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Classroom Study of SPN-812 in Children With ADHD | ||||
Official Title ICMJE | An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder | ||||
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. | ||||
Detailed Description | This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 2-arm, analog classroom study to evaluate the efficacy and safety of 200 mg/day SPN-812 compared to placebo in the treatment of children aged 6 through 11 years with ADHD. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | ADHD | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
248 | ||||
Estimated Study Completion Date ICMJE | November 2020 | ||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 11 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04016792 | ||||
Other Study ID Numbers ICMJE | 812P308 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Supernus Pharmaceuticals, Inc. | ||||
Study Sponsor ICMJE | Supernus Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Supernus Pharmaceuticals, Inc. | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |