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This study will be a randomized, double-blind, placebo-controlled crossover study to assess the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to placebo in non-smoking adults aged 18-55 with a diagnosis of ADHD, any subtype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTS21 25 mg tid/Placebo 25 mg tid | Active Comparator |
| |
| GTS21 75 mg tid/Placebo 75 mg tid | Active Comparator |
| |
| GTS21 150 mg tid/Placebo 150 mg tid | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTS21/Placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). | The proportion of subjects with Treatment Emergent Adverse Events. | Baseline to study completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Grove | CoMentis (formerly Athenagen) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Medical Center | Washington D.C. | District of Columbia | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 mg Tid | |
| FG001 | 75 mg Tid | |
| FG002 | 150 mg Tid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 25 mg Tid | |
| BG001 | 75 mg Tid | |
| BG002 | 150 mg Tid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). | The proportion of subjects with Treatment Emergent Adverse Events. | Posted | Number | % of subjects | Baseline to study completion |
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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 | 25 mg Tid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl Grove | CoMentis (formerly Athenagen) | 650-869-7600 | cgrove@comentis.com |
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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 |
|---|---|
| C088936 | 3-(2,4-dimethoxybenzylidene)anabaseine |
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| Duke University Medical Center |
| Durham |
| North Carolina |
| United States |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | 75 mg Tid | 0 | 16 | 13 | 18 |
| EG002 | 150 mg Tid | 0 | 8 | 8 | 8 |
| Dizziness | Nervous system disorders |
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| Somnolence | Nervous system disorders |
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| Sinus headache | Nervous system disorders |
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| Insomnia | Psychiatric disorders |
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| Fatigue | General disorders |
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| Pain | General disorders |
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| Nausea | Gastrointestinal disorders |
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| Abdominal Pain | Gastrointestinal disorders |
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| Dyspepsia | Gastrointestinal disorders |
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| Gastroesophageal Reflux Disease | Gastrointestinal disorders |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Decreased appetite | Metabolism and nutrition disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
|
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