ADHDPhase 3NCT04016792
Classroom Study of SPN-812 in Children With ADHD
A Phase 3 study testing 200 mg SPN-812 in people with ADHD, run by Supernus Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- 200 mg SPN-812
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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;
- Established hormonal contraceptive.
Who cannot join
- 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.
- Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents). Febrile seizures are not exclusionary and will be assessed on a case-by-case basis. If for any reason the subject received medication for a febrile seizure, this it will be exclusionary.
- 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.
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- 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.
- Positive urine drug screen at screening visit. A positive test for amphetamines is not exclusionary for subjects receiving a stimulant ADHD medication at the time of the screening visit, however, an additional urine drug screen should be performed at Visit 3. Subjects must discontinue all prohibited/ADHD medication (including stimulant, clonidine and guanfacine) at least 7 days prior to Visit 3.
- 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).
About this study
Official title: An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Placebo, 200 mg 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 will be administered once daily
200 mg SPN-812Drug
Also called SPN-812 Fixed Dose
200 mg SPN-812 will be administered once daily and compared to Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo qd Receives: Drug: Placebo |
| SPN-812 | Experimental | 200 mg SPN-812 Receives: Drug: 200 mg SPN-812 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 29 days
Secondary outcomes (10)
Effect of SPN-812 assessed longitudinally by SKAMP-CS
Change from baseline in SKAMP-CS at individual time points across the classroom day
Measured: 29 days
Effect of SPN-812 assessed longitudinally by Permanent Product (PERMP) math test
Change from baseline in PERMP math test number attempted and number correct at individual time points across the classroom day
Measured: 29 days
Effect of SPN-812 on Clinical Global Impression-Severity (CGI-S) scale
Change from baseline in CGI-S score
Measured: 29 days
Effect of SPN-812 on SKAMP Attention and SKAMP Deportment subscales
Change from baseline in mean SKAMP Attention and SKAMP Deportment scores, averaged from 8 post-dose assessments
Measured: 29 days
Effect of SPN-812 assessed longitudinally on SKAMP Attention and SKAMP Deportment subscales
Change from baseline in SKAMP Attention and SKAMP Deportment scores at individual time points across the classroom day
Measured: 29 days
Effect of SPN-812 assessed by ADHD Rating Scale-5 (ADHD-RS-5) Total Score and subscales
Change from baseline in ADHD-RS-5 Total Score, Hyperactivity/Impulsivity score and Inattention score
Measured: 29 days
Effect of SPN-812 assessed by Clinical Global Impression-Improvement (CGI-I) scale
Change from baseline in CGI-I score
Measured: 29 days
Effect of SPN-812 assessed by categorical CGI-I Responder Rate
Change from baseline in categorical CGI-I score
Measured: 29 days
Effect of SPN-812 assessed by 50% Responder Rate to ADHD Rating Scale-5 baseline
Percentage of subjects with at least 50% reduction in ADHD-RS-5 total score
Measured: 29 days
Effect of SPN-812 assessed by Conners 3rd Edition-Parent Report Short Form (Conners 3-PS) Composite T score
Change from baseline in Conners 3-PS Composite T score
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionNov 2020 (estimated)
Why it stopped: Study stopped before enrollment due to non-safety related corporate decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Schwabe, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016792
- Sponsor's protocol ID
- 812P308
- Status last verified
- Sep 2019
- First submitted
- 10 Jul 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT04016792
- Acronym / sponsor ID
- 812P308
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped before enrollment due to non-safety related corporate decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo qd |
| SPN-812 | Experimental | Drug: 200 mg SPN-812200 mg SPN-812 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents). Febrile seizures are not exclusionary and will be assessed on a case-by-case basis. If for any reason the subject received medication for a febrile seizure, this it will be exclusionary.
- 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.
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 will be administered once daily | Drug | Placebo |
| 200 mg SPN-812Also: SPN-812 Fixed Dose200 mg SPN-812 will be administered once daily and compared to Placebo | Drug | SPN-812 |
Primary outcome
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
10 secondary outcomes
Effect of SPN-812 assessed longitudinally by SKAMP-CS
Time frame: 29 days
Effect of SPN-812 assessed longitudinally by Permanent Product (PERMP) math test
Time frame: 29 days
Effect of SPN-812 on Clinical Global Impression-Severity (CGI-S) scale
Time frame: 29 days
Effect of SPN-812 on SKAMP Attention and SKAMP Deportment subscales
Time frame: 29 days
Effect of SPN-812 assessed longitudinally on SKAMP Attention and SKAMP Deportment subscales
Time frame: 29 days
Effect of SPN-812 assessed by ADHD Rating Scale-5 (ADHD-RS-5) Total Score and subscales
Time frame: 29 days
Effect of SPN-812 assessed by Clinical Global Impression-Improvement (CGI-I) scale
Time frame: 29 days
Effect of SPN-812 assessed by categorical CGI-I Responder Rate
Time frame: 29 days
Effect of SPN-812 assessed by 50% Responder Rate to ADHD Rating Scale-5 baseline
Time frame: 29 days
Effect of SPN-812 assessed by Conners 3rd Edition-Parent Report Short Form (Conners 3-PS) Composite T score
Time frame: 29 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Stefan Schwabe, MD study director
Chief Medical Officer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 200 mg SPN-812 in people with ADHD, run by Supernus Pharmaceuticals, Inc..
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 16 inclusion and 17 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: withdrawn, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of SPN-812 assessed by Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale- Combined Score (SKAMP-CS) (time frame: 29 days). 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 18 Sep 2019.