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| ID | Type | Description | Link |
|---|---|---|---|
| OV1012 | Other Identifier | Former study ID |
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The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
LGS poses a significant treatment challenge. No single antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Even with combination therapy, many LGS patients show resistance to treatment. Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy for some patients, although polytherapy and high medication doses are often associated with unfavorable adverse event profiles.
More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobazam Low Dose | Experimental |
| |
| Clobazam Medium Dose | Experimental |
| |
| Clobazam High Dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobazam Low Dose | Drug | 0.25 mg/kg/day; tablets; orally; for 15-18 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and 12-week maintenance period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the first 4 weeks of the 12-week maintenance period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in the Number of Non-drop Seizures. | This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Huntsville | Alabama | 35081 | United States | ||
| St. Joseph's Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21956725 | Result | Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Study Investigators. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology. 2011 Oct 11;77(15):1473-81. doi: 10.1212/WNL.0b013e318232de76. Epub 2011 Sep 28. | |
| 33825230 | Derived | Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clobazam Low Dose | 0.25 mg/kg/day; tablets; orally; for 15-18 weeks |
| FG001 | Clobazam Medium Dose | 0.5 mg/kg/day; tablets; orally; for 15-18 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Clobazam Medium Dose | Drug | 0.5 mg/kg/day; tablets; orally; for 15-18 weeks |
|
|
| Clobazam High Dose | Drug | 1.0 mg/kg/day; tablets; orally; for 15-18 weeks |
|
|
| Placebo | Drug | tablets; orally; daily for 15-18 weeks |
|
| Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period |
| Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the last 4 weeks of the 12-week maintenance period |
| Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the 12-week maintenance period |
| Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the first 4 weeks of the 12-week maintenance period |
| Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period |
| Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the last 4 weeks of the 12-week maintenance period |
| Tolerance | Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period. | 4-week baseline period and first 4/first 8 weeks of the maintenance period |
| Investigator Global Evaluations of the Patient's Overall Change in Symptoms. | The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". | Week 15 |
| Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". | Week 15 |
| 4-week baseline period and the 12-week maintenance period |
| Percent Reduction of Total (Drop and Non-Drop) Seizures. | This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition. | 4-week baseline period and 12-week maintenance period |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85216 | United States |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Pediatric Neurology and Epilepsy Center | Loxahatchee Groves | Florida | 33470 | United States |
| Child Neurology Center of NW FL | Pensacola | Florida | 32504 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Pediatric Epilepsy & Neurology Specialists | Tampa | Florida | 33609 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Pediatric Neurology of Idaho Children's Specialty Center | Boise | Idaho | 83712 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 61516 | United States |
| University of Kentucky, Kentucky Clinic, Department of Neurology | Lexington | Kentucky | 40536-0284 | United States |
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Minnesota Epilepsy Group | Saint Paul | Minnesota | 55012 | United States |
| The Comprehensive Epilepsy Care Center for Children and Adults | Chesterfield | Missouri | 63017 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| St. Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Clinical Research Center of New Jersey (CRCNJ) | Voorhees Township | New Jersey | 08043 | United States |
| University of Rochester Medical Center | Rochester | New York | 14450 | United States |
| University Neurology, Inc. | Cincinnati | Ohio | 45219 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson Epilepsy Center | Philadelphia | Pennsylvania | 19107 | United States |
| UTMG Pediatric Neurology | Memphis | Tennessee | 38105 | United States |
| Children's Medical Center at UT Southwestern-Dallas | Dallas | Texas | 75235 | United States |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine Pediatric Neurology | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0211 | United States |
| Strategic Health Evaluators | Chatswood | New South Wales | 2067 | Australia |
| Royal Melbourne Hospital Department of Neurology | Melbourne | Victoria | 3050 | Australia |
| Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre | Melbourne | Victoria | 3081 | Australia |
| Vitebsk Regional Diagnostic Center | Vitebsk | 210023 | Belarus |
| Neurology Center | Ahmedabad | Gujarat | 380006 | India |
| St. John's Medical College Hospital | Bangalore | Karnataka | 560034 | India |
| Malikatta Neuro Center | Mangalore | Karnataka | 575002 | India |
| K. S. Hedge Medical Academy | Mangalore | Karnataka | 575018 | India |
| Jaslok Hospital & Research Centre | Mumbai | Maharashtra | 400026 | India |
| KEM Hospital & Research Centre | Pune | Maharashtra | 411 011 | India |
| P.D. Hinduja National Hospital Medical Research Centre | Mumbai | Mumbai | 400016 | India |
| Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre | New Delhi | National Capital Territory of Delhi | 110002 | India |
| Institute of Human Behaviour and Allied Sciences | Delhi | New Delhi | 110095 | India |
| Deenanath Mangeshkar Hospital and Research Center | Erandawane | Pune | 411004 | India |
| Christian Medical College | Ludhiana | Punjab | 1410108 | India |
| Dr. Kamakshi Memorial Hospital | Chennai | Tamil Nadu | 600 100 | India |
| Chhatrapati Sahu Ji Maharaj Medical University | Lucknow | Uttra Pradesh | 226 003 | India |
| Apollo Gleneagles Hospitals | Kolkata | West Bengal | 700054 | India |
| Kaunas University of Medicine Hospital | Kaunas | LT 50009 | Lithuania |
| 27683846 | Derived | Gidal BE, Wechsler RT, Sankar R, Montouris GD, White HS, Cloyd JC, Kane MC, Peng G, Tworek DM, Shen V, Isojarvi J. Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study. Neurology. 2016 Oct 25;87(17):1806-1812. doi: 10.1212/WNL.0000000000003253. Epub 2016 Sep 28. |
| FG002 | Clobazam High Dose | 1.0 mg/kg/day; tablets; orally; for 15-18 weeks |
| FG003 | Placebo | tablets; orally; daily for 15-18 weeks |
| Modified Intent-to-Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clobazam Low Dose | 0.25 mg/kg/day; tablets; orally; for 15-18 weeks |
| BG001 | Clobazam Medium Dose | 0.5 mg/kg/day; tablets; orally; for 15-18 weeks |
| BG002 | Clobazam High Dose | 1.0 mg/kg/day; tablets; orally; for 15-18 weeks |
| BG003 | Placebo | tablets; orally; daily for 15-18 weeks |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | Modified Intent-to-Treat (MITT) population | Posted | Least Squares Mean | Full Range | Percent Reduction | 4-week baseline period and 12-week maintenance period |
|
|
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| Secondary | Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | MITT population | Posted | Least Squares Mean | Full Range | Percent reduction | 4-week baseline period and the first 4 weeks of the 12-week maintenance period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | Posted | Least Squares Mean | Full Range | Percent reduction | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | Posted | Least Squares Mean | Full Range | Percent reduction | 4-week baseline period and the last 4 weeks of the 12-week maintenance period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | Posted | Number | Percent of responders | 4-week baseline period and the 12-week maintenance period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | MITT | Posted | Number | Percent of responders | 4-week baseline period and the first 4 weeks of the 12-week maintenance period |
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| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | Posted | Number | Percent Responders | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | Posted | Number | Percent Responders | 4-week baseline period and the last 4 weeks of the 12-week maintenance period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tolerance | Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period. | MITT | Posted | Number | Participants | 4-week baseline period and first 4/first 8 weeks of the maintenance period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator Global Evaluations of the Patient's Overall Change in Symptoms. | The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". | Those patients in the MITT population who completed a Physician Global Evaluation at Week 15. | Posted | Number | participants | Week 15 |
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| Secondary | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". | Those patients in the MITT population who had a baseline and Week 15 parent/caregiver global evaluations were analyzed. | Posted | Number | participants | Week 15 |
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| Other Pre-specified | Percent Reduction in the Number of Non-drop Seizures. | This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. | Posted | Least Squares Mean | Full Range | Percent reduction | 4-week baseline period and the 12-week maintenance period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Reduction of Total (Drop and Non-Drop) Seizures. | This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition. | Posted | Least Squares Mean | Full Range | Percent reduction | 4-week baseline period and 12-week maintenance period |
|
19 weeks
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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 | Clobazam Low Dose | 0.25 mg/kg/day; tablets; orally; for 15-18 weeks | 3 | 58 | 42 | 58 | ||
| EG001 | Clobazam Medium Dose | 0.5 mg/kg/day; tablets; orally; for 15-18 weeks | 6 | 62 | 55 | 62 | ||
| EG002 | Clobazam High Dose | 1.0 mg/kg/day; tablets; orally; for 15-18 weeks | 5 | 59 | 45 | 59 | ||
| EG003 | Placebo | tablets; orally; daily for 15-18 weeks | 2 | 59 | 40 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Drug administration error | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myoclonic epilepsy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ultrasound abdomen abnormal | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
The sponsor must have the opportunity to review and approve all proposed abstracts, manuscripts, or presentations regarding this study prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Lundbeck LLC | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004829 | Epilepsy, Generalized |
| D012640 | Seizures |
| D065768 | Lennox Gastaut Syndrome |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078306 | Clobazam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.
| ANCOVA |
| 0.0015 |
| 95 |
| No |
| Superiority or Other |
| ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo. | ANCOVA | <0.0001 | 95 | No | Superiority or Other |
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