Trial · NCT00626236
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
NCT00626236, Phase 2, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2025-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems. Trials, record NCT00626236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00626236
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
- NCT number
- NCT00626236
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Conduct Disorder
- Interventions
- SPN-810, SPN-810, SPN-810, SPN-810
- First posted
- 2008-02-29
- Last updated
- 2025-12-09
- Results first posted
- 2025-09-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). |
| Secondary | The Changes From Baseline in the CGI-S | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after the administration of study medication. The severity of illness (CGI-S) is rated by the investigator on a 7-point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy. |
| Secondary | Clinical Global Impression - Improvement Scale (CGI-I) | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline on a 7-point scale with 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 lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). |
| Secondary | SNAP-IV ADHD Inattention | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #0-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the inattention subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12. |
| Secondary | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the Hyperactivity/Impulsivity subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12. |
| Secondary | SNAP-IV Subscales - ADHD Combined | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the combined subscale, the scores range from 0-54, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | score on a scale | MEAN |
| SECONDARY | The Changes From Baseline in the CGI-S | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | score on a scale | MEAN |
| SECONDARY | Clinical Global Impression - Improvement Scale (CGI-I) | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | score on a scale | MEAN |
| SECONDARY | SNAP-IV ADHD Inattention | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | score on a scale | MEAN |
| SECONDARY | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | score on a scale | MEAN |
| SECONDARY | SNAP-IV Subscales - ADHD Combined | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group284
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 1 5/10mg TDD | Mean Score at Baseline | 20.4 | Standard Deviation 5.22 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 2 10/20mg TDD | Mean Score at Baseline | 25.7 | Standard Deviation 6.98 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 3 15/30mg TDD | Mean Score at Baseline | 26.0 | Standard Deviation 5.51 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 4 20/40mg TDD | Mean Score at Baseline | 26.0 | Standard Deviation 7.63 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 1 5/10mg TDD | Visit 2 Change from Baseline | -0.6 | Standard Deviation 5.82 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 2 10/20mg TDD | Visit 2 Change from Baseline | -3.3 | Standard Deviation 5.94 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 3 15/30mg TDD | Visit 2 Change from Baseline | -2.6 | Standard Deviation 6.69 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 4 20/40mg TDD | Visit 2 Change from Baseline | -3.3 | Standard Deviation 5.72 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 1 5/10mg TDD | Visit 3 Change from Baseline | -0.6 | Standard Deviation 5.82 | score on a scale |
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Treatment 2 10/20mg TDD | Visit 3 Change from Baseline | -7.1 | Standard Deviation 9.95 | score on a scale |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment 1 5/10mg TDD | 20 | |
| Overall Study | STARTED | Treatment 2 10/20mg TDD | 19 | |
| Overall Study | STARTED | Treatment 3 15/30mg TDD | 19 | |
| Overall Study | STARTED | Treatment 4 20/40mg TDD | 20 | |
| Overall Study | COMPLETED | Treatment 1 5/10mg TDD | 14 | |
| Overall Study | COMPLETED | Treatment 2 10/20mg TDD | 12 | |
| Overall Study | COMPLETED | Treatment 3 15/30mg TDD | 15 | |
| Overall Study | COMPLETED | Treatment 4 20/40mg TDD | 14 | |
| Overall Study | NOT COMPLETED | Treatment 1 5/10mg TDD | 6 | |
| Overall Study | NOT COMPLETED | Treatment 2 10/20mg TDD | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | Somnolence | Nervous system disorders | Treatment 1 5/10mg TDD | 1 | 20 | |
| other | Somnolence | Nervous system disorders | Treatment 2 10/20mg TDD | 1 | 19 | |
| other | Somnolence | Nervous system disorders | Treatment 3 15/30mg TDD | 5 | 19 | |
| other | Somnolence | Nervous system disorders | Treatment 4 20/40mg TDD | 3 | 20 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Treatment 1 5/10mg TDD | 2 | 20 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Treatment 2 10/20mg TDD | 4 | 19 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Treatment 3 15/30mg TDD | 1 | 19 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Treatment 4 20/40mg TDD | 2 | 20 | |
| other | Weight decreased | General disorders | Treatment 1 5/10mg TDD | 0 | 20 | |
| other | Weight decreased | General disorders | Treatment 2 10/20mg TDD | 2 | 19 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment 1 5/10mg TDD | 0 | 20 |
| Total, all-cause mortality | Treatment 2 10/20mg TDD | 0 | 19 |
| Total, all-cause mortality | Treatment 3 15/30mg TDD | 0 | 19 |
| Total, all-cause mortality | Treatment 4 20/40mg TDD | 0 | 20 |
| Total, other adverse events | Treatment 1 5/10mg TDD | 12 | 20 |
| Total, other adverse events | Treatment 2 10/20mg TDD | 15 | 19 |
| Total, other adverse events | Treatment 3 15/30mg TDD | 17 | 19 |
| Total, other adverse events | Treatment 4 20/40mg TDD | 17 | 20 |
| Total, serious adverse events | Treatment 1 5/10mg TDD | 0 | 20 |
| Total, serious adverse events | Treatment 2 10/20mg TDD | 0 | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22372512 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00626236
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