Trial · NCT04016779
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
NCT04016779, Phase 3, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2022-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD. Trials, record NCT04016779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04016779
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
- NCT number
- NCT04016779
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 374 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- Interventions
- Placebo, SPN-812
- First posted
- 2019-07-11
- Last updated
- 2022-07-12
- Results first posted
- 2022-07-12
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Baseline and Week 6 | The Primary Endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A Total score is calculated by summating the ratings of all 18 items (range: 0-54; the higher the score, the more severe the ADHD symptoms). A lower change from baseline AISRS Total score (\<0) represents a better outcome. |
| Secondary | Effect of SPN-812 on the Clinical Global Impression - Severity of Illness (CGI-S) Scale | Baseline and Week 6 | The Key Secondary Endpoint was the change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) score at Week 6. The CGI-S is a single item clinician-rated assessment of the severity of subject's condition (ADHD symptoms) in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated on a 7-point scale with 1 = Normal, not at all ill, asymptomatic, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Among the most extremely ill patients. Successful therapy is indicated by a lower overall score in subsequent testing. A lower change from baseline CGI-S score (\<0) represents a better outcome. |
| Secondary | Effect of SPN-812 on the Clinical Response Rate as Assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale | Week 6 | An additional secondary endpoint was the percentage of subjects with a Clinical Global Impression - Severity of Illness (CGI-S) score of 1 or 2 ("responders") at Week 6. The CGI-S is a single item clinician-rated assessment of the severity of subject's condition (ADHD symptoms) in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated on a 7-point scale with 1 = Normal, not at all ill, asymptomatic, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Among the most extremely ill patients. Responder rate values range from 0 to 100%. A higher percentage represents a greater number of subjects who are "responders". |
| Secondary | Effect of SPN-812 on the Clinical Global Impression - Improvement (CGI-I) Scale | Week 6 | An additional secondary endpoint was the Clinical Global Impression - Improvement (CGI-I) score at Week 6. The CGI-I scale is a single item clinician-rated assessment of how much the subject's condition (ADHD) has improved, worsened or has not changed relative to his/her baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point 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". A CGI-I score \<4 represents a better outcome. |
| Secondary | Effect of SPN-812 on Clinical Response Rate as Assessed by the Clinical Global Impression - Improvement (CGI-I) Scale | Week 6 | An additional secondary endpoint was the percentage of subjects with a CGI-I score of 1 or 2 ("responders") at Week 6. The CGI-I scale is a single item clinician-rated assessment of how much the subject's condition (ADHD) has improved, worsened or has not changed relative to his/her baseline state prior to the beginning of treatment. The CGI-I is rated on a 7-point 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". Responder rate values can range from 0 to 100%. A higher percentage represents a greater number of subjects who are "responders". |
| Secondary | Effect of SPN-812 on Symptoms of Anxiety as Assessed by the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline and Week 6 | An additional secondary endpoint was the change from baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total score at Week 6. The GAD-7 is a self-reported 7-item questionnaire for screening and measuring the severity of generalized anxiety disorder. The subject rates each item on 4-point scale (0-3), where 0 = "Not at all", 1 = "Several days", 2 = "Over half the days", and 3 = "Nearly every day". The total score is calculated by summated the ratings of all 7 items. The total score can range between 0 to 21; the higher the score, the more severe the symptoms of anxiety. A lower change from baseline GAD-7 total score (\<0) represents a better outcome. |
| Secondary | Effect of SPN-812 on Inattention Symptoms as Assessed by the Inattention Subscale of the Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Week 6 | An additional secondary endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) "Inattention" subscale score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. The Inattention subscale score is calculated by summating the ratings of all 9 Inattention items (range: 0-27; the higher the score, the more severe the symptoms). A lower change from baseline Inattention subscale score (\<0) represents a better outcome. |
| Secondary | Effect of SPN-812 on Hyperactivity/Impulsivity Symptoms as Assessed by the Hyperactivity/Impulsivity Subscale of the Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Week 6 | An additional secondary endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) "Hyperactivity/Impulsivity" subscale score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. The Hyperactivity/Impulsivity subscale score is calculated by summating the ratings of all 9 Hyperactivity/Impulsivity items (range: 0-27; the higher the score, the more severe the symptoms). A lower change from baseline Hyperactivity/Impulsivity subscale score (\<0) represents a better outcome. |
| Secondary | Effect of SPN-812 on 30% Clinical Response Rate as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Week 6 | An additional secondary endpoint was the percentage of subjects with a 30% or greater reduction in their change from baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A Total score is calculated by summating the ratings of all 18 items (range: 0-54; the higher the score, the more severe the symptoms). The Total score is converted to a percent change from baseline. 30% responder rate values can range between 0 and 100%. A higher percentage represents a greater number of subjects who are "responders". |
| Secondary | Effect of SPN-812 on 50% Clinical Response Rate as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS). | Baseline and Week 6 | An additional secondary endpoint was the percentage of subjects with a 50% or greater reduction in their change from baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The clinician/investigator rates the subject on each item using a 4-point scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A Total score is calculated by summating the ratings of all 18 items (range: 0-54; the higher the score, the more severe the symptoms). The Total score is converted to a percent change from baseline. 50% responder rate values can range between 0 and 100%. A higher percentage represents a greater number of subjects who are "responders". |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Effect of SPN-812 on the Clinical Global Impression - Severity of Illness (CGI-S) Scale | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Effect of SPN-812 on the Clinical Response Rate as Assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale | Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | percentage of subjects | NUMBER |
| SECONDARY | Effect of SPN-812 on the Clinical Global Impression - Improvement (CGI-I) Scale | Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Effect of SPN-812 on Clinical Response Rate as Assessed by the Clinical Global Impression - Improvement (CGI-I) Scale | Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | Percentage of subjects | NUMBER |
| SECONDARY | Effect of SPN-812 on Symptoms of Anxiety as Assessed by the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Effect of SPN-812 on Inattention Symptoms as Assessed by the Inattention Subscale of the Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Effect of SPN-812 on Hyperactivity/Impulsivity Symptoms as Assessed by the Hyperactivity/Impulsivity Subscale of the Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Effect of SPN-812 on 30% Clinical Response Rate as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | percentage of subjects | NUMBER |
| SECONDARY | Effect of SPN-812 on 50% Clinical Response Rate as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS). | Baseline and Week 6 | Full Analysis Set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult ADHD Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment. | percentage of subjects | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | Placebo | -11.7 | Standard Error 0.90 | units on a scale | |
| Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | SPN-812 | -15.5 | Standard Error 0.91 | units on a scale | |
| Effect of SPN-812 on the Clinical Global Impression - Severity of Illness (CGI-S) Scale | Placebo | -1.0 | Standard Deviation 0.10 | units on a scale | |
| Effect of SPN-812 on the Clinical Global Impression - Severity of Illness (CGI-S) Scale | SPN-812 | -1.4 | Standard Deviation 0.10 | units on a scale | |
| Effect of SPN-812 on the Clinical Response Rate as Assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale | Placebo | 25.2 | percentage of subjects | ||
| Effect of SPN-812 on the Clinical Response Rate as Assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale | SPN-812 | 30.8 | percentage of subjects | ||
| Effect of SPN-812 on the Clinical Global Impression - Improvement (CGI-I) Scale | Placebo | 2.9 | Standard Error 0.09 | units on a scale | |
| Effect of SPN-812 on the Clinical Global Impression - Improvement (CGI-I) Scale | SPN-812 | 2.6 | Standard Error 0.09 | units on a scale | |
| Effect of SPN-812 on Clinical Response Rate as Assessed by the Clinical Global Impression - Improvement (CGI-I) Scale | Placebo | 37.8 | Percentage of subjects | ||
| Effect of SPN-812 on Clinical Response Rate as Assessed by the Clinical Global Impression - Improvement (CGI-I) Scale | SPN-812 | 48.5 | Percentage of subjects |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 184 | |
| Overall Study | STARTED | SPN-812 | 190 | |
| Overall Study | Treated | Placebo | 183 | |
| Overall Study | Treated | SPN-812 | 189 | |
| Overall Study | COMPLETED | Placebo | 140 | |
| Overall Study | COMPLETED | SPN-812 | 127 | |
| Overall Study | NOT COMPLETED | Placebo | 44 | |
| Overall Study | NOT COMPLETED | SPN-812 | 63 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 183 | |
| other | Constipation | Gastrointestinal disorders | SPN-812 | 11 | 189 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 4 | 183 | |
| other | Dry mouth | Gastrointestinal disorders | SPN-812 | 18 | 189 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 183 | |
| other | Nausea | Gastrointestinal disorders | SPN-812 | 23 | 189 | |
| other | Fatigue | General disorders | Placebo | 6 | 183 | |
| other | Fatigue | General disorders | SPN-812 | 23 | 189 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 5 | 183 | |
| other | Decreased appetite | Metabolism and nutrition disorders | SPN-812 | 19 | 189 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 183 |
| Total, all-cause mortality | SPN-812 | 0 | 189 |
| Total, other adverse events | Placebo | 43 | 183 |
| Total, other adverse events | SPN-812 | 147 | 189 |
| Total, serious adverse events | Placebo | 2 | 183 |
| Total, serious adverse events | SPN-812 | 0 | 189 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SPN-812 vs Placebo: deaths from any cause | Trial comparisons |
| SPN-812 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04016779
GET https://conductscience.org/api/trials/v1/NCT04016779/registered?page=2