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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00518713
Registration number
NCT00518713
Ethics application status
Date submitted
20/08/2007
Date registered
21/08/2007
Date last updated
9/02/2012
Titles & IDs
Public title
Clobazam in Patients With Lennox-Gastaut Syndrome
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Scientific title
Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome
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Secondary ID [1]
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OV1012
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Secondary ID [2]
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13110A
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Epilepsy, Generalized
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Seizures
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Clobazam Low Dose
Treatment: Drugs - Clobazam Medium Dose
Treatment: Drugs - Clobazam High Dose
Treatment: Drugs - Placebo
Experimental: Clobazam Low Dose -
Experimental: Clobazam Medium Dose -
Experimental: Clobazam High Dose -
Placebo comparator: Placebo -
Treatment: Drugs: Clobazam Low Dose
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
Treatment: Drugs: Clobazam Medium Dose
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
Treatment: Drugs: Clobazam High Dose
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
Treatment: Drugs: Placebo
tablets; orally; daily for 15-18 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
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Assessment method [1]
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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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Timepoint [1]
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4-week baseline period and 12-week maintenance period
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Secondary outcome [1]
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Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
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Assessment method [1]
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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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Timepoint [1]
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4-week baseline period and the first 4 weeks of the 12-week maintenance period
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Secondary outcome [2]
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Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
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Assessment method [2]
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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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Timepoint [2]
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4-week baseline period and the middle 4 weeks of the 12-week maintenance period
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Secondary outcome [3]
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Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
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Assessment method [3]
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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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Timepoint [3]
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4-week baseline period and the last 4 weeks of the 12-week maintenance period
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Secondary outcome [4]
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Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
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Assessment method [4]
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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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Timepoint [4]
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4-week baseline period and the 12-week maintenance period
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Secondary outcome [5]
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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).
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Assessment method [5]
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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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Timepoint [5]
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4-week baseline period and the first 4 weeks of the 12-week maintenance period
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Secondary outcome [6]
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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).
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Assessment method [6]
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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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Timepoint [6]
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4-week baseline period and the middle 4 weeks of the 12-week maintenance period
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Secondary outcome [7]
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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).
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Assessment method [7]
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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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Timepoint [7]
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4-week baseline period and the last 4 weeks of the 12-week maintenance period
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Secondary outcome [8]
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Tolerance
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Assessment method [8]
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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.
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Timepoint [8]
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4-week baseline period and first 4/first 8 weeks of the maintenance period
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Secondary outcome [9]
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Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
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Assessment method [9]
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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".
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Timepoint [9]
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Week 15
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Secondary outcome [10]
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Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
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Assessment method [10]
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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".
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Timepoint [10]
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Week 15
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Eligibility
Key inclusion criteria
* Patient must have been <11 years of age at the onset of LGS.
* Patient must have LGS.
* Patient must be on at least 1 AED.
* Parent or caregiver must be able to keep an accurate seizure diary.
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Minimum age
2
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Etiology of patient's seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.
* Patient has had an episode of status epilepticus within 12 weeks of baseline.
* Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
* Patient has a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines.
* Patient is taking more than 3 concurrent AEDs.
* Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling.
* If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable for at least 30 days prior to screening.
* Patient has taken corticotropins in the 6 months prior to screening.
* Patient is currently taking long-term systemic steroids (excluding inhaled mediation for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.
* If the patient is taking felbamate, has been taking it for less than 1 year prior to screening.
Other protocol-defined inclusion and exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2010
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Sample size
Target
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Accrual to date
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Final
238
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Strategic Health Evaluators - Chatswood
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Recruitment hospital [2]
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Royal Melbourne Hospital Department of Neurology - Melbourne
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Recruitment hospital [3]
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Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre - Melbourne
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Recruitment postcode(s) [1]
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2067 - Chatswood
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Recruitment postcode(s) [2]
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3050 - Melbourne
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Recruitment postcode(s) [3]
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3081 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Idaho
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Illinois
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New York
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Ohio
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Texas
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Virginia
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Belarus
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Vitebsk
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India
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Delhi
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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India
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New Delhi
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India
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Pune
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India
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Punjab
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India
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Tamilnadu
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India
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Uttra Pradesh
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India
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West Bengal
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India
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Mumbai
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Lithuania
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Kaunas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Lundbeck LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00518713
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Trial related presentations / publications
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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Email contact via H. Lundbeck A/S
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Address
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[email protected]
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00518713
Download to PDF