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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Treatment 1: SPN-810 5mg/day for subjects <30kg and 10mg/day for subjects ≥30kg |
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| Treatment 2 | Experimental | Treatment 2: SPN-810 10mg/day for subjects <30kg and 20mg/day for subjects ≥30kg. |
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| Treatment 3 | Experimental | Treatment 3: SPN-810 15mg/day for subjects <30kg and 30mg/day for subjects ≥30kg. |
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| Treatment 4 | Experimental | Treatment 4: SPN-810 20mg/day for subjects <30kg and 40mg/day for subjects ≥30kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPN-810 | Drug | 1.67mg capsule taken TID |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Findling, MD | University Hospitals Case Medical Center/Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Clinical Research Center | Bradenton | Florida | 32408 | United States | ||
| Sarkis Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22372512 | Derived | Stocks JD, Taneja BK, Baroldi P, Findling RL. A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems. J Child Adolesc Psychopharmacol. 2012 Apr;22(2):102-11. doi: 10.1089/cap.2011.0087. Epub 2012 Feb 28. |
| Label | URL |
|---|---|
| A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 5/10mg TDD | SPN-810: capsule taken three times a day |
| FG001 | Treatment 2 10/20mg TDD | SPN-810: capsule taken TID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2009 | Jul 2, 2025 |
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| SPN-810 | Drug | 3.33mg capsule taken TID |
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| SPN-810 | Drug | 5mg capsule taken TID |
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| SPN-810 | Drug | 6.67 mg capsule taken TID |
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| 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). | 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. | 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. | 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. | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
| Gainesville |
| Florida |
| 32607 |
| United States |
| CNS Healthcare | Orlando | Florida | 32806 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| The Psychopharm Research Cntr - LSU Dept of Psychiatry | Shreveport | Louisiana | 71103 | United States |
| IPS Research | Oklahoma City | Oklahoma | 73103 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Alliance Research Group | Richmond | Virginia | 23229 | United States |
| Northwest Clinical Trials | Bellevue | Washington | 98004 | United States |
| FG002 | Treatment 3 15/30mg TDD | SPN-810: capsule taken TID |
| FG003 | Treatment 4 20/40mg TDD | SPN-810: capsule taken TID |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 5/10mg TDD | SPN-810: capsule taken three times a day |
| BG001 | Treatment 2 10/20mg TDD | SPN-810: capsule taken TID |
| BG002 | Treatment 3 15/30mg TDD | SPN-810: capsule taken TID |
| BG003 | Treatment 4 20/40mg TDD | SPN-810: capsule taken TID |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | Posted | Mean | Standard Deviation | score on a scale | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
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| Secondary | 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. | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | Posted | Mean | Standard Deviation | score on a scale | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
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| Secondary | 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). | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | Posted | Mean | Standard Deviation | score on a scale | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
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| Secondary | 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. | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | Posted | Mean | Standard Deviation | score on a scale | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
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| Secondary | 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. | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | Posted | Mean | Standard Deviation | score on a scale | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
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| Secondary | 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. | ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment | Posted | Mean | Standard Deviation | score on a scale | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) |
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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
All AEs were collected from time of informed consent through 7 days after last dose (non-serious) and through 30-day follow-up (serious AEs). Events were coded using MedDRA Version 11.1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment 1 5/10mg TDD | SPN-810: capsule taken three times a day | 0 | 20 | 0 | 20 | 12 | 20 |
| EG001 | Treatment 2 10/20mg TDD | SPN-810: capsule taken TID | 0 | 19 | 0 | 19 | 15 | 19 |
| EG002 | Treatment 3 15/30mg TDD | SPN-810: capsule taken TID | 0 | 19 | 1 | 19 | 17 | 19 |
| EG003 | Treatment 4 20/40mg TDD | SPN-810: capsule taken TID | 0 | 20 | 1 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Abnormal behavior | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment | Abnormal behavior was incorrectly recorded as behavioral activation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Weight decreased | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Upper Resipiratory Tract Infection | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pain in extremity | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianpiera Ceresoli-Borroni Director Clinical Research | Supernus Pharmaceuticals | 3018382521 | gceresoliborroni@supernus.com |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019955 | Conduct Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008972 | Molindone |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Visit 2 Change from Baseline |
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| Visit 3 Change from Baseline |
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| Visit 4 Change from Baseline |
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| Visit 5 Change from Baseline |
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| Visit 6 Change from Baseline |
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| Visit 7 Change from Baseline |
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| Visit 8 Change from Baseline |
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| Visit 9 Change from Baseline |
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| Visit 10 Change from Baseline |
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| Visit 11 Change from Baseline |
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| Visit 12 Change from Baseline |
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SPN-810: capsule taken TID |
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SPN-810: capsule taken TID
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SPN-810: capsule taken TID |
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| Treatment 4 20/40mg TDD |
SPN-810: capsule taken TID |
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| Treatment 4 20/40mg TDD |
SPN-810: capsule taken TID |
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