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| ID | Type | Description | Link |
|---|---|---|---|
| OV1002 | 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 subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects 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. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.
More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobazam Low Dose | Experimental |
| |
| Clobazam High Dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobazam Low Dose | Drug | 5 to 10 mg/day with doses in the morning and at bedtime; orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Number of Drop Seizures. | 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 4-week maintenance period |
| A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. | 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 4-week maintenance period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Childrens Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19170737 | Background | Conry JA, Ng YT, Paolicchi JM, Kernitsky L, Mitchell WG, Ritter FJ, Collins SD, Tracy K, Kormany WN, Abdulnabi R, Riley B, Stolle J. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia. 2009 May;50(5):1158-66. doi: 10.1111/j.1528-1167.2008.01935.x. Epub 2008 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clobazam Low Dose | 5 to 10 mg/day with doses in the morning and at bedtime; orally |
| FG001 | Clobazam High Dose | 5 to 40 mg/day with doses in the morning and at bedtime; orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Clobazam High Dose | Drug | 5 to 40 mg/day with doses in the morning and at bedtime; orally |
|
|
| 4-week baseline period and 4-week maintenance period |
| 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 3 |
| 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 7 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Pediatric Epilepsy & Neurology Specialists | Tampa | Florida | 33609 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Childrens Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Minnesota Epilepsy Group, P.A. | Saint Paul | Minnesota | 55102 | United States |
| Children's Hospital | Columbus | Ohio | 43205 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38105 | United States |
| Dallas Pediatric Neurology Associates | Dallas | Texas | 75230 | United States |
| Texas Child Neurology, LLP | Plano | Texas | 75075 | United States |
| Monarch Medical Research | Norfolk | Virginia | 23510 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clobazam Low Dose | 5 to 10 mg/day with doses in the morning and at bedtime; orally |
| BG001 | Clobazam High Dose | 5 to 40 mg/day with doses in the morning and at bedtime; orally |
| BG002 | Total | Total of all reporting groups |
| 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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| 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. | 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 Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period. | Posted | Mean | Standard Deviation | Percent Reduction | 4-week baseline period and 4-week maintenance period |
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| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | 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 participants | 4-week baseline period and 4-week maintenance period |
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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". | MITT population, baseline evaluations compared to Week 3 evaluations. | Posted | Number | participants | Week 3 |
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| Primary | A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. | 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 | Median | Full Range | Percent Reduction | 4-week baseline period and the 4-week maintenance period |
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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". | MITT population, baseline evaluations compared to Week 7 evaluations. | Posted | Number | participants | Week 7 |
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Up to 15 weeks
Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
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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 | 5 to 10 mg/day with doses in the morning and at bedtime; orally | 1 | 32 | 27 | 32 | ||
| EG001 | Clobazam High Dose | 5 to 40 mg/day with doses in the morning and at bedtime; orally | 3 | 36 | 31 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Sleep Apnea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Behavior | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Hypomania | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
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| Irritability | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
Principal Investigator agrees to delete, at Sponsor's request, from any proposed Public Presentation any information or material that Sponsor deems confidential or proprietary.
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D000078306 | Clobazam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| 0.0001 |
1-sided Wilcoxon signed rank test was used to assess the difference from baseline. |
| 95 |
| No |
| Superiority or Other |
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