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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004377-16 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam 1000 mg/day to 2000 mg/day group | Experimental | Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. |
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| Levetiracetam 3000 mg/day group | Experimental | Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period. They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam (LEV) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period | A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
| From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period | Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 19 | Aomori | Japan | ||||
| 33 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set (RS). RS consists of all subjects who were randomized to the study groups.
This multicenter study started to enroll subjects in December 2011 in order to end up with 27 centers with enrolled subjects in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam 1000 mg/Day to 2000 mg/Day Group |
|
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period |
| Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period | A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
| From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period |
| Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period | Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs. | From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period |
| Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group | Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve. | During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year |
| Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group | Median time to withdrawal will be estimated from the Kaplan-Meier curve. | During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year |
| Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group | Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve. | During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year |
| Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group | Median time to withdrawal will be estimated from the Kaplan-Meier curve. | During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year |
| Asaka |
| Japan |
| 21 | Daitō | Japan |
| 12 | Fujisawa | Japan |
| 14 | Hamamatsu | Japan |
| 11 | Himeji | Japan |
| 30 | Hirosaki | Japan |
| 8 | Kagoshima | Japan |
| 20 | Kamakura | Japan |
| 17 | Kawasaki | Japan |
| 3 | Kitakyushu | Japan |
| 26 | Kodaira | Japan |
| 9 | Kokubunji | Japan |
| 32 | Kyoto | Japan |
| 25 | Miyakonojō | Japan |
| 5 | Nagoya Aichi | Japan |
| 4 | Nara | Japan |
| 22 | Okayama | Japan |
| 15 | Osaka | Japan |
| 27 | Osaka | Japan |
| 13 | Saitama | Japan |
| 1 | Sakai | Japan |
| 29 | Sapporo | Japan |
| 24 | Sayama | Japan |
| 2 | Toyonaka | Japan |
| 7 | Ube | Japan |
| 18 | Yamagata | Japan |
| Levetiracetam 3000 mg/Day Group |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set (SS). SS consists of all subjects in the Enrolled Set, who received at least 1 dose of the Investigational Medicinal Product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam 1000 mg/Day to 2000 mg/Day Group |
|
| BG001 | Levetiracetam 3000 mg/Day Group |
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| BG002 | Total Title |
| 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, Categorical | Count of Participants | Participants |
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| 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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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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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 | Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period | A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
| Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose. | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period |
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| Secondary | Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period | Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs. | Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose. | Posted | Number | 95% Confidence Interval | percentage of participants | From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period | A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
| Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period | Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs. | Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. | Posted | Number | 95% Confidence Interval | percentage of participants | From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group | Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve. | Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose. | Posted | Median | 95% Confidence Interval | days | During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group | Median time to withdrawal will be estimated from the Kaplan-Meier curve. | Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose. | Posted | Median | 95% Confidence Interval | days | During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group | Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve. | Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. | Posted | Median | 95% Confidence Interval | days | During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group | Median time to withdrawal will be estimated from the Kaplan-Meier curve. | Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. | Posted | Median | 95% Confidence Interval | days | During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year |
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Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit.
Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam 1000 mg/Day to 2000 mg/Day Group |
| 8 | 61 | 58 | 61 | ||
| EG001 | Levetiracetam 3000 mg/Day Group |
| 2 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritability | General disorders | MedDRA16.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Kaposi's varicelliform eruption | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Postictal state | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA16.0 | Non-systematic Assessment |
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| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA16.0 | Non-systematic Assessment |
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| Postictal psychosis | Psychiatric disorders | MedDRA16.0 | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA16.0 | Non-systematic Assessment |
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| Meniscus removal | Surgical and medical procedures | MedDRA16.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA16.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Lip ulceration | Gastrointestinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA16.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA16.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA16.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA16.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA16.0 | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA16.0 | Non-systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA16.0 | Non-systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | MedDRA16.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA16.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA16.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA16.0 | Non-systematic Assessment |
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| Urine ketone body present | Investigations | MedDRA16.0 | Non-systematic Assessment |
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| Blood urine present | Investigations | MedDRA16.0 | Non-systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA16.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA16.0 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA16.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Amnestic disorder | Nervous system disorders | MedDRA16.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA16.0 | Non-systematic Assessment |
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| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA16.0 | Non-systematic Assessment |
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| Ketonuria | Renal and urinary disorders | MedDRA16.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA16.0 | Non-systematic Assessment |
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| Acquired phimosis | Reproductive system and breast disorders | MedDRA16.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA16.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA16.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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