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This study is a multicenter, dose-optimized, open-label safety study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).
The study will consist of a Screening Period, a Dose Optimization Phase, and a Treatment Phase and a Follow-Up Visit, as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label KP415 | Experimental | KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP415 oral capsule | Drug | Once-daily oral dose |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Treatment-Emergent Adverse Events (TEAEs) | TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in ADHD-RS-5 Total Score | The clinician-administered ADHD-RS-5 is an 18-item scale that rates ADHD symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS-5 scores range from 0 to 54. The 18 items can be divided into two 9-item subscales: One for hyperactivity/impulsivity and the other for inattentiveness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Childress, MD | Center for Psychiatry And Behavioral Medicine Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research | Little Rock | Arkansas | 72211 | United States | ||
| MCB Clinical Research Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37204277 | Derived | Childress AC, Cutler AJ, Patel M, Oh C. Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. J Child Adolesc Psychopharmacol. 2023 May;33(4):134-142. doi: 10.1089/cap.2023.0012. | |
| 36809150 | Derived | Childress AC, Marraffino A, Cutler AJ, Oh C, Brams MN. Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. J Child Adolesc Psychopharmacol. 2023 Mar;33(2):51-58. doi: 10.1089/cap.2022.0076. Epub 2023 Feb 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2019 | May 7, 2021 |
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| Up to 12 months |
| Change From Baseline in CGI-S | The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in this study) on a scale from 1 (not at all ill) to 7 (among the most severely ill). | Up to 12 months |
| Change From Baseline in Children's Sleep Habits Questionnaire | The modified, abbreviated Children's Sleep Habits Questionnaire (CSHQ) will be used to assess the sleep behavior. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Scores range from 33-99, with higher scores represent more disturbed sleep. Scores were obtained during a clinician-directed interview with the parent/guardian/caregiver. | Up to 12 months |
| Colorado Springs |
| Colorado |
| 80910 |
| United States |
| Meridien Research | Bradenton | Florida | 34201 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Meridien Research | Maitland | Florida | 32751 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Neuro-Behavioral Clinical Research | Canton | Ohio | 44718 | United States |
| Midwest Clinical Research Center, LLC | Dayton | Ohio | 45417 | United States |
| Oregon Center for Clinical Investigations, Inc. | Portland | Oregon | 97214 | United States |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | 97301 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| FutureSearch Trials | Austin | Texas | 78731 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77007 | United States |
| Houston Clinical Trials | Houston | Texas | 77098 | United States |
| Entered Treatment Phase | Treatment Phase Safety Population, which includes all enrolled subjects who received at least 1 dose of study medication and had at least 1 post-dose safety assessment in the Treatment Phase |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Subjects With Treatment-Emergent Adverse Events (TEAEs) | TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ADHD-RS-5 Total Score | The clinician-administered ADHD-RS-5 is an 18-item scale that rates ADHD symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS-5 scores range from 0 to 54. The 18 items can be divided into two 9-item subscales: One for hyperactivity/impulsivity and the other for inattentiveness. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CGI-S | The CGI-S is a clinician-rated scale that evaluates the severity of psychopathology (ADHD symptoms in this study) on a scale from 1 (not at all ill) to 7 (among the most severely ill). | The Overall Efficacy Population was comprised of 225 subjects. Due to early terminations, 223 subjects remained at Visit 6 (Day 30) and 153 subjects remained at Visit 17 (Day 360) | Posted | Count of Participants | Participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Children's Sleep Habits Questionnaire | The modified, abbreviated Children's Sleep Habits Questionnaire (CSHQ) will be used to assess the sleep behavior. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. Scores range from 33-99, with higher scores represent more disturbed sleep. Scores were obtained during a clinician-directed interview with the parent/guardian/caregiver. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
|
|
1 year
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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 | Active Treatment | Optimized dose of KP415 (serdexmethylphenidate [SDX] Cl/ d-methylphenidate [d-MPH] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) | 0 | 238 | 3 | 238 | 143 | 238 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | asthma, status asthmaticus, bronchospasm, acute respiratory failure, hyperglycaemia |
| |
| seizure | Nervous system disorders | Systematic Assessment |
| ||
| aggression | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric disorders | Psychiatric disorders | Systematic Assessment |
| ||
| infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| investigations | Investigations | Systematic Assessment |
| ||
| gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| nervous system | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerald Orehostky | KemPharm | 321-250-3699 | gorehostky@kempharm.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2018 | May 7, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000718174 | serdexmethylphenidate and dexmethylphenidate |
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| Unknown or Not Reported |
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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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| Title | Measurements |
|---|---|
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| Subjects with an SAE |
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| Subjects with an AE leading to death |
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| 4 = Moderately ill |
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| 5 = Markedly ill |
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| 6 = Severely ill |
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| 7 = Among the most extremely ill patients |
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