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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
Scientific title
Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome
Secondary ID [1] 0 0
OV1012
Secondary ID [2] 0 0
13110A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Epilepsy, Generalized 0 0
Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
Timepoint [1] 0 0
4-week baseline period and 12-week maintenance period
Secondary outcome [1] 0 0
Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
Timepoint [1] 0 0
4-week baseline period and the first 4 weeks of the 12-week maintenance period
Secondary outcome [2] 0 0
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
Timepoint [2] 0 0
4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Secondary outcome [3] 0 0
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
Timepoint [3] 0 0
4-week baseline period and the last 4 weeks of the 12-week maintenance period
Secondary outcome [4] 0 0
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
Timepoint [4] 0 0
4-week baseline period and the 12-week maintenance period
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
4-week baseline period and the first 4 weeks of the 12-week maintenance period
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
4-week baseline period and the last 4 weeks of the 12-week maintenance period
Secondary outcome [8] 0 0
Tolerance
Timepoint [8] 0 0
4-week baseline period and first 4/first 8 weeks of the maintenance period
Secondary outcome [9] 0 0
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Timepoint [9] 0 0
Week 15
Secondary outcome [10] 0 0
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Timepoint [10] 0 0
Week 15

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.
Minimum age
2 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
238
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Strategic Health Evaluators - Chatswood
Recruitment hospital [2] 0 0
Royal Melbourne Hospital Department of Neurology - Melbourne
Recruitment hospital [3] 0 0
Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
3081 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Belarus
State/province [24] 0 0
Vitebsk
Country [25] 0 0
India
State/province [25] 0 0
Delhi
Country [26] 0 0
India
State/province [26] 0 0
Gujarat
Country [27] 0 0
India
State/province [27] 0 0
Karnataka
Country [28] 0 0
India
State/province [28] 0 0
Maharashtra
Country [29] 0 0
India
State/province [29] 0 0
New Delhi
Country [30] 0 0
India
State/province [30] 0 0
Pune
Country [31] 0 0
India
State/province [31] 0 0
Punjab
Country [32] 0 0
India
State/province [32] 0 0
Tamilnadu
Country [33] 0 0
India
State/province [33] 0 0
Uttra Pradesh
Country [34] 0 0
India
State/province [34] 0 0
West Bengal
Country [35] 0 0
India
State/province [35] 0 0
Mumbai
Country [36] 0 0
Lithuania
State/province [36] 0 0
Kaunas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lundbeck LLC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00518713
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.
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00518713