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The study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.
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The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin (Core Study and Open-label Extension Phase) | Experimental | Participants will be randomized to receive lorcaserin administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to less than (<) 20, 20 to <40, and greater than or equal to (>=) 40 kilogram (kg) will be 5, 10, and 20 milligram per day (mg/day) respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin. |
|
| Placebo (Core Study) + Lorcaserin (Open-label Extension Phase) | Placebo Comparator | Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to <20, 20 to <40, and >=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matching to lorcaserin oral tablet, administered as oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period | Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: ([post-baseline value minus the baseline value] / baseline value) *100. | Baseline up to Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline | A responder was defined as a participant who experienced a reduction of 50% or greater in the frequency of convulsive seizures during the 14-week treatment period compared to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. |
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Key Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
Key Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama / University of Alabama at Birmingham | Birmingham | Alabama | 35226 | United States | ||
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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The study was conducted in two phases (Core Study and an Open-label Extension Phase). A total of 27 participants were screened, of which 5 were screen failures and 22 were enrolled to receive study treatment. This study was terminated due to sponsor decision, and not due to safety concerns. As pre-planned, the data collection and analysis were based on treatments (placebo or lorcaserin) in Core Study and Extension Phase. The dose level wise data was not collected in this study.
Participants took part at 15 investigative sites in Canada and the United States from 23 September 2020 to 15 August 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Study: Placebo | Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks. |
| FG001 | Core Study: Lorcaserin | Participants weighing 10 to less than (<) 20 kilogram (kg), 20 to <40 kg, and greater than or equal to (>=) 40 kg received lorcaserin oral suspension, at dose of 5 milligrams per day (mg/day), 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg. The total treatment duration in Core Study was 14 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Study: 14 Weeks |
|
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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 | Jul 9, 2020 | Sep 19, 2025 |
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| Lorcaserin | Drug | Lorcaserin oral tablet, administered as oral suspension. |
|
|
| Baseline up to Week 14 |
| Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period | A responder was a participant who experienced a 100% reduction (seizure freedom) in convulsive seizure frequency in the 14-week treatment period relative to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. | Baseline up to Week 14 |
| Core Study: Plasma Concentrations of Lorcaserin | Plasma Concentrations of Lorcaserin was evaluated and reported. | Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose |
| Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) that emerges during treatment, was absent at pretreatment (baseline) or reemerges during treatment, was present at pretreatment (baseline) but stopped before treatment or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product. | From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18) |
| University of California Los Angeles (UCLA) |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCSD Rady's Children's Hosptial | San Diego | California | 92123 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Northwest Florida Clinical Research Group | Gulf Breeze | Florida | 32561 | United States |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Miami Children's Hospital - Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
| Pediatric Neurology, P.A. | Winter Park | Florida | 32789 | United States |
| Rare Disease Research Center Pediatrics, LLC | Atlanta | Georgia | 30318 | United States |
| Mid-Atlantic Epilepsy and Sleep Center - Bethesda | Bethesda | Maryland | 20817 | United States |
| Spectrum Health/ Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| University of Missouri, Department of Child Health, Division of Neurology | Columbia | Missouri | 65201 | United States |
| Institute of Neurology and Neurosurgery at Saint Barnabas | Livingston | New Jersey | 07039 | United States |
| Northwell Health - Neuroscience Institute at Great Neck | New Hyde Park | New York | 10075 | United States |
| NYU Langone Comprehensive Epilepsy Center | New York | New York | 10016 | United States |
| New York Medical College | New York | New York | 10019-1147 | United States |
| NorthWell Health - Lennox Hill Hospital | New York | New York | 11021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7025 | United States |
| Duke University Hospital Center | Durham | North Carolina | 27710 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| Alberta Children's Hospital | Calgary | Alberta | AB T3B 6A8 | Canada |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 1C9 | Canada |
| BC Children's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada |
| Children's Hospital - VH, London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| University of Toronto Division of Hematology Oncology/The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| FG002 | Extension Phase: Placebo Then Lorcaserin | Participants who received placebo in Core Study and entered Extension Phase, received lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to <20 kg, 20 to <40 kg, and >=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks. |
| FG003 | Extension Phase: Lorcaserin | Participants who received lorcaserin in Core Study and entered Extension Phase, received lorcaserin at the same dose they were receiving at end of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension Phase: 12 Weeks |
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The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/ Lorcaserin | Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks in Core Study followed by lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to <20 kg, 20 to <40 kg, and >=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Core Study was 14 weeks and 12 weeks in Extension Phase. |
| BG001 | Lorcaserin/ Lorcaserin | Participants weighing 10 to <20 kg, 20 to <40 kg, and >=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively in Core Study. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg. During Extension Phase, participants continued the same dose of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Core Study was 14 weeks and 12 weeks in Extension Phase. |
| 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 | year |
| |||||||||||||||
| 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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| 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 | Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period | Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: ([post-baseline value minus the baseline value] / baseline value) *100. | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. | Posted | Median | Full Range | percent change | Baseline up to Week 14 |
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| Secondary | Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline | A responder was defined as a participant who experienced a reduction of 50% or greater in the frequency of convulsive seizures during the 14-week treatment period compared to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. | Posted | Number | percentage of participants | Baseline up to Week 14 |
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| Secondary | Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period | A responder was a participant who experienced a 100% reduction (seizure freedom) in convulsive seizure frequency in the 14-week treatment period relative to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. | The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. | Posted | Number | percentage of participants | Baseline up to Week 14 |
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| Secondary | Core Study: Plasma Concentrations of Lorcaserin | Plasma Concentrations of Lorcaserin was evaluated and reported. | The Pharmacokinetic (PK) analysis set was the group of all randomized participants from whom at least measurable lorcaserin plasma concentration was obtained with associated documented dosing history. Here 'n' refers to number of participants analyzed at different timepoints for this outcome measure. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose |
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| Secondary | Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) that emerges during treatment, was absent at pretreatment (baseline) or reemerges during treatment, was present at pretreatment (baseline) but stopped before treatment or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product. | The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | Posted | Count of Participants | Participants | From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18) |
|
Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
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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 | Core Study: Placebo | Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks. | 0 | 10 | 0 | 10 | 7 | 10 |
| EG001 | Core Study: Lorcaserin | Participants weighing 10 to <20 kg, 20 to <40 kg, and >=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg. The total treatment duration in Core Study was 14 weeks. | 0 | 11 | 1 | 11 | 8 | 11 |
| EG002 | Extension Phase: Placebo Then Lorcaserin | Participants who received placebo in Core Study and entered Extension Phase, received lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to <20 kg, 20 to <40 kg, and >=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG003 | Extension Phase: Lorcaserin | Participants who received lorcaserin in Core Study and entered Extension Phase, received lorcaserin at the same dose they were receiving at end of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to <20 kg and up to 20 mg/day for those weighing 20 to <40 kg and >=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks. | 0 | 7 | 1 | 7 | 3 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dacryostenosis acquired | Eye disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
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| Body temperature decreased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Sluggishness | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA Version 27.0 | Systematic Assessment |
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This study was terminated due to sponsor decision, and not due to safety concerns.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2024 | Sep 19, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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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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