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CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-12 (reboxetine) | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-12 (Reboxetine) | Drug | Dosed orally, twice daily for up to 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | Presented as LSmeans. A positive change is indicative of improvement. | 2 weeks |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CONCERT Study Site | Birmingham | Alabama | 35213 | United States | ||
| CONCERT Study Site |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
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Crossover Design: Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to Sequence 1 [AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks] or Sequence 2 [placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks].
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Sequence 1 - AXS-12 (reboxetine) for three weeks followed by placebo for three weeks |
| FG001 | Sequence 2 | Sequence 2 - Placebo for three weeks followed by AXS-12 (reboxetine) for three weeks |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and SAP | Apr 25, 2019 |
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| Placebo |
| Drug |
Dosed orally, twice daily for up to 3 weeks |
|
| Alameda |
| California |
| 94501 |
| United States |
| CONCERT Study Site | Santa Ana | California | 92705 | United States |
| CONCERT Study Site | Boulder | Colorado | 80301 | United States |
| CONCERT Study Site | Miami | Florida | 33126 | United States |
| CONCERT Study Site | Gainesville | Georgia | 30501 | United States |
| CONCERT Study Site | Stockbridge | Georgia | 30281 | United States |
| CONCERT Study Site | Fort Wayne | Indiana | 46804 | United States |
| CONCERT Study Site | Chevy Chase | Maryland | 20815 | United States |
| CONCERT Study Site | The Bronx | New York | 10467 | United States |
| CONCERT Study Site | Cincinnati | Ohio | 45219 | United States |
| CONCERT Study Site | Columbia | South Carolina | 29201 | United States |
| CONCERT Study Site | Austin | Texas | 78731 | United States |
| CONCERT Study Site | San Antonio | Texas | 78229 | United States |
| Dosed With AXS-12 |
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| Dosed With Placebo |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Sequence 1 - AXS-12 (reboxetine) for three weeks followed by placebo for three weeks |
| BG001 | Sequence 2 | Sequence 2 - Placebo for three weeks followed by AXS-12 (reboxetine) for three weeks |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks | Presented as LSmeans. A positive change is indicative of improvement. | Posted | Least Squares Mean | Standard Error | weekly cataplexy attacks | 2 weeks |
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Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
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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 | AXS-12 (Reboxetine) | Adverse events collected while subjects were in the AXS-12 (reboxetine) period of either Sequence 1 or Sequence 2. | 0 | 21 | 0 | 21 | 9 | 21 |
| EG001 | Placebo | Adverse events collected while subjects were in the Placebo period of either Sequence 1 or Sequence 2. | 0 | 20 | 0 | 20 | 8 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA Dictionary | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Dictionary | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Dictionary | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Dictionary | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Dictionary | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Dictionary | Systematic Assessment |
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| Allergy to animal | Immune system disorders | MedDRA Dictionary | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA Dictionary | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA Dictionary | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA Dictionary | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA Dictionary | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Dictionary | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Dictionary | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Dictionary | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Dictionary | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Streicher, Senior Vice President, Clinical Operations | Axsome Therapeutics, Inc. | 212-332-5061 | cstreicher@axsome.com |
| Dec 7, 2022 |
| Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: SAP only | Nov 12, 2019 | Aug 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D006970 | Disorders of Excessive Somnolence |
| D002385 | Cataplexy |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077593 | Reboxetine |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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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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