A Phase 2 interventional study of SPN-810 and SPN-810 in Attention Deficit Disorder With Hyperactivity and Conduct Disorder, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 9 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Supernus Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.
This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 78 is close to the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Supernus Pharmaceuticals, Inc. is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment 1: SPN-810 5mg/day for subjects \<30kg and 10mg/day for subjects ≥30kg
Drug: SPN-810
Treatment 2: SPN-810 10mg/day for subjects \<30kg and 20mg/day for subjects ≥30kg.
Drug: SPN-810
Treatment 3: SPN-810 15mg/day for subjects \<30kg and 30mg/day for subjects ≥30kg.
Drug: SPN-810
Treatment 4: SPN-810 20mg/day for subjects \<30kg and 40mg/day for subjects ≥30kg.
Drug: SPN-810
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score
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).
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
The Changes From Baseline in the CGI-S
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.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Clinical Global Impression - Improvement Scale (CGI-I)
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).
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV ADHD Inattention
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.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity
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.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
SNAP-IV Subscales - ADHD Combined
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.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
| Milestone | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Started | 20 | 19 | 19 | 20 |
| Completed | 14 | 12 | 15 | 14 |
| Not completed | 6 | 7 | 4 | 6 |
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).
| score on a scale | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Mean Score at Baseline | 20.4 ± 5.22 | 25.7 ± 6.98 | 26.0 ± 5.51 | 26.0 ± 7.63 |
| Visit 2 Change from Baseline | -0.6 ± 5.82 | -3.3 ± 5.94 | -2.6 ± 6.69 | -3.3 ± 5.72 |
| Visit 3 Change from Baseline | -0.6 ± 5.82 | -7.1 ± 9.95 | -3.4 ± 6.78 | -6.1 ± 6.69 |
| Visit 4 Change from Baseline | -0.6 ± 5.82 | -7.1 ± 9.95 | -5.0 ± 9.57 | -8.9 ± 6.95 |
| Visit 5 Change from Baseline | -0.6 ± 5.82 | -7.1 ± 9.95 | -5.0 ± 9.57 | -11.7 ± 7.68 |
| Visit 6 Change from Baseline | -2.7 ± 5.38 | -7.8 ± 9.60 | -6.4 ± 9.31 | -11.6 ± 7.51 |
| Visit 7 Change from Baseline | -4.8 ± 6.07 | -8.1 ± 9.79 | -7.6 ± 8.71 | -12.9 ± 8.35 |
| Visit 8 Change from Baseline | -6.0 ± 7.19 | -7.6 ± 8.37 | -9.0 ± 9.84 | -14.5 ± 9.24 |
| Visit 9 Change from Baseline | -8.1 ± 6.33 | -7.8 ± 8.21 | -9.7 ± 9.74 | -14.8 ± 8.49 |
| Visit 10 Change from Baseline | -7.9 ± 6.86 | -7.9 ± 8.36 | -11.2 ± 8.93 | -13.6 ± 9.87 |
| Visit 11 Change from Baseline | -7.9 ± 6.77 | -9.9 ± 9.31 | -9.2 ± 10.60 | -14.5 ± 8.65 |
| Visit 12 Change from Baseline | -7.0 ± 7.13 | -8.7 ± 9.31 | -8.2 ± 10.51 | -14.3 ± 8.64 |
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.
| score on a scale | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Baseline Score | 4.35 ± 0.587 | 4.74 ± 0.562 | 4.63 ± 0.684 | 4.70 ± 0.470 |
| Visit 2 Change From Baseline | -0.20 ± 0.523 | -0.26 ± 0.562 | -0.11 ± 0.459 | -0.20 ± 0.523 |
| Visit 3 Change From Baseline | -0.20 ± 0.523 | -0.47 ± 0.772 | -0.37 ± 0.496 | -0.45 ± 0.510 |
| Visit 4 Change From Baseline | -0.20 ± 0.523 | -0.47 ± 0.772 | -0.63 ± 0.831 | -0.75 ± 0.716 |
| Visit 5 Change From Baseline | -0.20 ± 0.523 | -0.47 ± 0.772 | -0.63 ± 0.831 | -1.10 ± 0.788 |
| Visit 6 Change From Baseline | -0.20 ± 0.523 | -0.68 ± 0.749 | -0.89 ± 0.809 | -1.30 ± 0.923 |
| Visit 7 Change From Baseline | -0.55 ± 0.686 | -0.79 ± 0.713 | -1.26 ± 0.991 | -1.30 ± 0.923 |
| Visit 8 Change From Baseline | -0.85 ± 0.813 | -0.79 ± 0.855 | -1.37 ± 0.895 | -1.50 ± 1.192 |
| Visit 9 Change From Baseline | -1.05 ± 0.759 | -0.89 ± 0.875 | -1.32 ± 0.946 | -1.70 ± 1.218 |
| Visit 10 Change From Baseline | -1.10 ± 0.968 | -0.84 ± 0.898 | -1.53 ± 0.964 | -1.65 ± 1.137 |
| Visit 11 Change From Baseline | -1.15 ± 0.875 | -1.05 ± 0.970 | -1.37 ± 1.012 | -1.55 ± 1.099 |
| Visit 12 Change From Baseline | -1.00 ± 0.973 | -1.00 ± 1.000 | -1.26 ± 0.933 | -1.75 ± 1.293 |
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).
| score on a scale | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Visit 2 Change from Baseline | 0.00 ± 0.0 | 0.00 ± 0.0 | 0.00 ± 0.0 | 0.00 ± 0.0 |
| Visit 3 Change from Baseline | 0.00 ± 0.000 | -0.41 ± 0.795 | -0.21 ± 0.631 | -0.42 ± 0.961 |
| Visit 4 Change from Baseline | 0.00 ± 0.000 | -0.41 ± 0.795 | -0.58 ± 0.961 | -0.68 ± 0.820 |
| Visit 5 Change from Baseline | 0.00 ± 0.000 | -0.41 ± 0.795 | -0.58 ± 0.961 | -1.16 ± 1.167 |
| Visit 6 Change from Baseline | -0.12 ± 0.697 | -0.76 ± 0.903 | -0.79 ± 0.918 | -1.26 ± 1.046 |
| Visit 7 Change from Baseline | -0.59 ± 0.939 | -0.88 ± 1.111 | -1.21 ± 0.918 | -1.26 ± 1.046 |
| Visit 8 Change from Baseline | -0.88 ± 0.928 | -0.88 ± 1.219 | -1.42 ± 1.017 | -1.26 ± 1.098 |
| Visit 9 Change from Baseline | -1.06 ± 0.827 | -0.94 ± 1.144 | -1.26 ± 0.933 | -1.37 ± 1.012 |
| Visit 10 Change from Baseline | -1.00 ± 1.118 | -0.88 ± 1.317 | -1.53 ± 1.073 | -1.42 ± 1.017 |
| Visit 11 Change from Baseline | -1.29 ± 0.985 | -0.94 ± 1.435 | -1.32 ± 1.003 | -1.37 ± 1.012 |
| Visit 12 Change from Baseline | -1.12 ± 1.219 | -1.00 ± 1.000 | -1.26 ± 0.872 | -1.32 ± 1.057 |
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.
| score on a scale | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Baseline Score | 18.20 ± 6.810 | 20.42 ± 4.501 | 20.00 ± 4.190 | 21.05 ± 4.211 |
| Visit 2 Change from Baseline | -1.55 ± 5.010 | -1.74 ± 4.593 | -1.84 ± 5.167 | 0.10 ± 5.200 |
| Visit 3 Change from Baseline | -1.55 ± 5.010 | -3.79 ± 5.149 | -3.84 ± 4.729 | -1.35 ± 5.234 |
| Visit 4 Change from Baseline | -1.55 ± 5.010 | -3.79 ± 5.149 | -5.11 ± 5.517 | -2.35 ± 5.770 |
| Visit 5 Change from Baseline | -1.55 ± 5.010 | -3.79 ± 5.149 | -5.11 ± 5.517 | -5.30 ± 7.420 |
| Visit 6 Change from Baseline | -1.15 ± 5.556 | -4.21 ± 5.583 | -7.16 ± 4.752 | -5.60 ± 5.888 |
| Visit 7 Change from Baseline | -2.55 ± 5.104 | -5.84 ± 4.729 | -6.42 ± 5.984 | -6.00 ± 7.732 |
| Visit 8 Change from Baseline | -3.95 ± 6.126 | -5.68 ± 5.197 | -7.05 ± 6.302 | -6.65 ± 7.088 |
| Visit 9 Change from Baseline | -5.65 ± 6.385 | -4.42 ± 4.706 | -7.05 ± 5.902 | -8.30 ± 7.794 |
| Visit 10 Change from Baseline | -5.15 ± 7.206 | -5.42 ± 4.834 | -8.89 ± 6.341 | -7.55 ± 8.733 |
| Visit 11 Change from Baseline | -5.65 ± 7.006 | -5.63 ± 5.058 | -8.11 ± 6.420 | -8.20 ± 7.885 |
| Visit 12 Change from Baseline | -4.35 ± 6.150 | -6.32 ± 5.558 | -6.84 ± 5.956 | -8.15 ± 7.611 |
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.
| score on a scale | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Baseline Score | 19.60 ± 5.933 | 21.74 ± 5.173 | 19.11 ± 5.517 | 20.95 ± 4.989 |
| Visit 2 Change from Baseline | -0.90 ± 4.166 | -1.47 ± 3.821 | -1.42 ± 4.562 | -1.05 ± 3.832 |
| Visit 3 Change from Baseline | -0.90 ± 4.166 | -3.32 ± 4.785 | -3.47 ± 6.123 | -2.05 ± 4.915 |
| Visit 4 Change from Baseline | -0.90 ± 4.166 | -3.32 ± 4.785 | -3.74 ± 6.814 | -3.80 ± 5.483 |
| Visit 5 Change from Baseline | -0.90 ± 4.166 | -3.32 ± 4.785 | -3.74 ± 6.814 | -5.85 ± 6.706 |
| Visit 6 Change from Baseline | -2.30 ± 4.802 | -4.16 ± 5.367 | -5.37 ± 5.510 | -6.05 ± 5.520 |
| Visit 7 Change from Baseline | -3.90 ± 4.909 | -4.84 ± 4.598 | -5.32 ± 5.991 | -7.10 ± 7.826 |
| Visit 8 Change from Baseline | -5.25 ± 6.624 | -4.47 ± 4.439 | -6.21 ± 6.545 | -7.60 ± 7.408 |
| Visit 9 Change from Baseline | -7.00 ± 6.383 | -3.79 ± 4.379 | -5.79 ± 5.534 | -9.10 ± 7.594 |
| Visit 10 Change from Baseline | -5.90 ± 6.656 | -5.16 ± 5.449 | -8.26 ± 6.393 | -8.35 ± 7.271 |
| Visit 11 Change from Baseline | -6.65 ± 6.620 | -5.47 ± 4.846 | -6.37 ± 6.576 | -9.00 ± 7.691 |
| Visit 12 Change from Baseline | -5.55 ± 6.739 | -5.79 ± 5.442 | -5.42 ± 6.963 | -8.50 ± 7.309 |
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.
| score on a scale | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| Baseline Score | 37.80 ± 11.414 | 42.16 ± 7.537 | 39.11 ± 8.888 | 42.00 ± 8.240 |
| Visit 2 Change from Baseline | -2.45 ± 7.957 | -3.21 ± 7.627 | -3.26 ± 8.736 | -0.95 ± 8.420 |
| Visit 3 Change from Baseline | -2.45 ± 7.957 | -7.11 ± 9.579 | -7.32 ± 9.995 | -3.40 ± 9.338 |
| Visit 4 Change from Baseline | -2.45 ± 7.957 | -7.11 ± 9.579 | -8.84 ± 11.758 | -6.15 ± 10.569 |
| Visit 5 Change from Baseline | -2.45 ± 7.957 | -7.11 ± 9.579 | -8.84 ± 11.758 | -11.15 ± 13.287 |
| Visit 6 Change from Baseline | -3.45 ± 9.854 | -8.37 ± 10.073 | -12.53 ± 9.697 | -11.65 ± 10.554 |
| Visit 7 Change from Baseline | -6.45 ± 9.361 | -10.68 ± 8.838 | -11.74 ± 11.293 | -13.10 ± 15.082 |
| Visit 8 Change from Baseline | -9.20 ± 12.194 | -10.16 ± 8.902 | -13.26 ± 12.355 | -14.25 ± 13.845 |
| Visit 9 Change from Baseline | -12.65 ± 12.006 | -8.21 ± 8.203 | -12.84 ± 10.678 | -17.40 ± 14.702 |
| Visit 10 Change from Baseline | -11.05 ± 13.477 | -10.58 ± 9.371 | -17.16 ± 11.701 | -15.90 ± 15.362 |
| Visit 11 Change from Baseline | -12.30 ± 13.111 | -11.11 ± 8.730 | -14.47 ± 12.294 | -17.20 ± 14.877 |
| Visit 12 Change from Baseline | -9.90 ± 12.251 | -12.11 ± 9.944 | -12.26 ± 12.596 | -16.65 ± 14.203 |
Collected over Adverse event data were collected from first dose through 7 days after last dose for non-serious AEs, and through 30 days post-treatment for SAEs (total study duration 16-19 weeks including follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment 1 5/10mg TDD | 0/20 (0%) | 0/20 (0%) | 12/20 (60%) |
| Treatment 2 10/20mg TDD | 0/19 (0%) | 0/19 (0%) | 15/19 (78.9%) |
| Treatment 3 15/30mg TDD | 0/19 (0%) | 1/19 (5.3%) | 17/19 (89.5%) |
| Treatment 4 20/40mg TDD | 0/20 (0%) | 1/20 (5%) | 17/20 (85%) |
| Event | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| AgitationPsychiatric disorders | 0/20 | 0/19 | 1/19 | 0/20 |
| Abnormal behaviorPsychiatric disorders | 0/20 | 0/19 | 0/19 | 1/20 |
| Event | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD |
|---|---|---|---|---|
| SomnolenceNervous system disorders | 1/20 | 1/19 | 5/19 | 3/20 |
| Abdominal pain upperGastrointestinal disorders | 2/20 | 4/19 | 1/19 | 2/20 |
| FatigueGeneral disorders | 2/20 | 0/19 | 1/19 | 4/20 |
| SedationNervous system disorders | 0/20 | 0/19 | 0/19 | 4/20 |
| Weight decreasedGeneral disorders | 0/20 | 2/19 | 3/19 | 3/20 |
| Upper Resipiratory Tract InfectionReproductive system and breast disorders | 2/20 | 1/19 | 3/19 | 1/20 |
| HeadacheGeneral disorders | 1/20 | 0/19 | 1/19 | 3/20 |
| InsomniaPsychiatric disorders | 2/20 | 2/19 | 1/19 | 2/20 |
| Decreased appetiteMetabolism and nutrition disorders | 2/20 | 1/19 | 2/19 | 0/20 |
| AkathisiaNervous system disorders | 1/20 | 0/19 | 2/19 | 1/20 |
| Age, Continuous(years) | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD | Total |
|---|---|---|---|---|---|
| Mean | 8.5 ± 1.88 | 9.4 ± 1.98 | 8.8 ± 2.12 | 8.8 ± 2.00 | 8.8 ± 1.98 |
| Sex: Female, Male(Participants) | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD | Total |
|---|---|---|---|---|---|
| Female | 1 | 3 | 6 | 1 | 11 |
| Male | 19 | 16 | 13 | 19 | 67 |
| Ethnicity (NIH/OMB)(Participants) | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 5 | 1 | 7 |
| Not Hispanic or Latino | 19 | 19 | 14 | 19 | 71 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 8 | 9 | 7 | 33 |
| White | 11 | 11 | 8 | 13 | 43 |
| More than one race | 0 | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Treatment 1 5/10mg TDD | Treatment 2 10/20mg TDD | Treatment 3 15/30mg TDD | Treatment 4 20/40mg TDD | Total |
|---|---|---|---|---|---|
| United States | 20 | 19 | 19 | 20 | 78 |
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Studies of the drug tested here: Molindone
Attention Deficit Disorder with Hyperactivity →
Supernus Pharmaceuticals, Inc. →