Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 2NCT02633527
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
A Phase 2 study testing 100mg SPN-812, 200mg SPN-812 and 300mg SPN-812 in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Supernus Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- 100mg SPN-812, 200mg SPN-812 and 300mg SPN-812
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 25 Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
About this study
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
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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).
- Being tested
- Placebo, 100mg SPN-812, 200mg SPN-812, 300mg SPN-812, 400mg SPN-812
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called PBO
Placebo was administered once daily
100mg SPN-812Drug
Also called SPN-812, Low Dose
100mg SPN-812 was administered once daily and compared to placebo
200mg SPN-812Drug
Also called SPN-812, Low-Medium Dose
200mg SPN-812 was administered once daily and compared to placebo
300mg SPN-812Drug
Also called SPN-812, Medium-High Dose
300mg SPN-812 was administered once daily and compared to placebo
400mg SPN-812Drug
Also called SPN-812, High Dose
400mg SPN-812 was administered once daily and compared to placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, qd, oral capsule Receives: Drug: Placebo |
| 100mg SPN-812 | Experimental | 100mg SPN-812, qd, oral capsule Receives: Drug: 100mg SPN-812 |
| 200mg SPN-812 | Experimental | 200mg SPN-812, qd, oral capsule Receives: Drug: 200mg SPN-812 |
| 300mg SPN-812 | Experimental | 300mg SPN-812, qd, oral capsule Receives: Drug: 300mg SPN-812 |
| 400mg SPN-812 | Experimental | 400mg SPN-812, qd, oral capsule Receives: Drug: 400mg SPN-812 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8 (End of Study)
Secondary outcomes (2)
Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale
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.
Measured: Week 8 (End of Study)
Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale
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.
Measured: Baseline to Week 8 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start1 Feb 2016
- Primary completion25 Jul 2016
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph T. Hull, PhD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633527
- Sponsor's protocol ID
- 812P202
- Status last verified
- Aug 2020
- First submitted
- 15 Dec 2015
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02633527
- Acronym / sponsor ID
- 812P202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, qd, oral capsule |
| 100mg SPN-812 | Experimental | Drug: 100mg SPN-812100mg SPN-812, qd, oral capsule |
| 200mg SPN-812 | Experimental | Drug: 200mg SPN-812200mg SPN-812, qd, oral capsule |
| 300mg SPN-812 | Experimental | Drug: 300mg SPN-812300mg SPN-812, qd, oral capsule |
| 400mg SPN-812 | Experimental | Drug: 400mg SPN-812400mg SPN-812, qd, oral capsule |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: PBOPlacebo was administered once daily | Drug | Placebo |
| 100mg SPN-812Also: SPN-812, Low Dose100mg SPN-812 was administered once daily and compared to placebo | Drug | 100mg SPN-812 |
| 200mg SPN-812Also: SPN-812, Low-Medium Dose200mg SPN-812 was administered once daily and compared to placebo | Drug | 200mg SPN-812 |
| 300mg SPN-812Also: SPN-812, Medium-High Dose300mg SPN-812 was administered once daily and compared to placebo | Drug | 300mg SPN-812 |
| 400mg SPN-812Also: SPN-812, High Dose400mg SPN-812 was administered once daily and compared to placebo | Drug | 400mg SPN-812 |
Primary outcome
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.
2 secondary outcomes
Effect of SPN-812 on Clinical Global Impression - Improvement (CGI-I) Scale
Time frame: Week 8 (End of Study)
Effect of SPN-812 on the Clinical Global Impression - Severity (CGI-S) Scale
Time frame: Baseline to Week 8 (End of Study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph T. Hull, PhD study director
Supernus Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 100mg SPN-812, 200mg SPN-812 and 300mg SPN-812 in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Supernus Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.