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Clobazam in Patients With Lennox-Gastaut Syndrome

Primary Purpose

Epilepsy, Epilepsy, Generalized, Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clobazam Low Dose
Clobazam Medium Dose
Clobazam High Dose
Placebo
Sponsored by
Lundbeck LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Lennox-Gastaut Syndrome, Drop seizures, Clobazam

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • University of Alabama at Birmingham
  • St. Joseph's Hospital and Medical Center
  • Phoenix Children's Hospital
  • Childrens Hospital Los Angeles
  • The Children's Hospital
  • Children's National Medical Center
  • Pediatric Neurology and Epilepsy Center
  • Child Neurology Center of NW FL
  • University of South Florida
  • Pediatric Epilepsy & Neurology Specialists
  • Medical College of Georgia
  • Pediatric Neurology of Idaho Children's Specialty Center
  • Rush University Medical Center
  • University of Chicago Medical Center
  • Children's Memorial Hospital
  • University of Kentucky, Kentucky Clinic, Department of Neurology
  • LSU Health Sciences Center
  • Mid-Atlantic Epilepsy and Sleep Center
  • Massachusetts General Hospital
  • Minnesota Epilepsy Group
  • The Comprehensive Epilepsy Care Center for Children and Adults
  • Dartmouth-Hitchcock Medical Center
  • Robert Wood Johnson University Hospital
  • St. Joseph's Regional Medical Center
  • Clinical Research Center of New Jersey (CRCNJ)
  • University of Rochester Medical Center
  • University Neurology, Inc.
  • The Children's Hospital of Philadelphia
  • Jefferson Epilepsy Center
  • UTMG Pediatric Neurology
  • Children's Medical Center at UT Southwestern-Dallas
  • Cook Children's Health Care System
  • Baylor College of Medicine Pediatric Neurology
  • Virginia Commonwealth University
  • Strategic Health Evaluators
  • Royal Melbourne Hospital Department of Neurology
  • Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre
  • Vitebsk Regional Diagnostic Center
  • Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre
  • Neurology Center
  • St. John's Medical College Hospital
  • Malikatta Neuro Center
  • K. S. Hedge Medical Academy
  • Jaslok Hospital & Research Centre
  • KEM Hospital & Research Centre
  • Institute of Human Behaviour and Allied Sciences
  • Deenanath Mangeshkar Hospital and Research Center
  • Christian Medical College
  • Dr. Kamakshi Memorial Hospital
  • Chhatrapati Sahu Ji Maharaj Medical University
  • Apollo Gleneagles Hospitals
  • P.D. Hinduja National Hospital Medical Research Centre
  • Kaunas University of Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Clobazam Low Dose

Clobazam Medium Dose

Clobazam High Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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".
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".

Full Information

First Posted
August 20, 2007
Last Updated
January 6, 2012
Sponsor
Lundbeck LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00518713
Brief Title
Clobazam in Patients With Lennox-Gastaut Syndrome
Official Title
Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundbeck LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Epilepsy, Generalized, Seizures
Keywords
Epilepsy, Lennox-Gastaut Syndrome, Drop seizures, Clobazam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clobazam Low Dose
Arm Type
Experimental
Arm Title
Clobazam Medium Dose
Arm Type
Experimental
Arm Title
Clobazam High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clobazam Low Dose
Other Intervention Name(s)
Onfi™
Intervention Description
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
Intervention Type
Drug
Intervention Name(s)
Clobazam Medium Dose
Other Intervention Name(s)
Onfi™
Intervention Description
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
Intervention Type
Drug
Intervention Name(s)
Clobazam High Dose
Other Intervention Name(s)
Onfi™
Intervention Description
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablets; orally; daily for 15-18 weeks
Primary Outcome Measure Information:
Title
Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
Description
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.
Time Frame
4-week baseline period and 12-week maintenance period
Secondary Outcome Measure Information:
Title
Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
Description
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.
Time Frame
4-week baseline period and the first 4 weeks of the 12-week maintenance period
Title
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
Description
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.
Time Frame
4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Title
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
Description
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.
Time Frame
4-week baseline period and the last 4 weeks of the 12-week maintenance period
Title
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
Description
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.
Time Frame
4-week baseline period and the 12-week maintenance period
Title
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).
Description
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.
Time Frame
4-week baseline period and the first 4 weeks of the 12-week maintenance period
Title
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).
Description
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.
Time Frame
4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Title
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).
Description
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.
Time Frame
4-week baseline period and the last 4 weeks of the 12-week maintenance period
Title
Tolerance
Description
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.
Time Frame
4-week baseline period and first 4/first 8 weeks of the maintenance period
Title
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Description
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".
Time Frame
Week 15
Title
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Description
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".
Time Frame
Week 15
Other Pre-specified Outcome Measures:
Title
Percent Reduction in the Number of Non-drop Seizures.
Description
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.
Time Frame
4-week baseline period and the 12-week maintenance period
Title
Percent Reduction of Total (Drop and Non-Drop) Seizures.
Description
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.
Time Frame
4-week baseline period and 12-week maintenance period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35081
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85216
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
The Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Pediatric Neurology and Epilepsy Center
City
Loxahatchee
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Child Neurology Center of NW FL
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Pediatric Epilepsy & Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Pediatric Neurology of Idaho Children's Specialty Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
61516
Country
United States
Facility Name
University of Kentucky, Kentucky Clinic, Department of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Minnesota Epilepsy Group
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55012
Country
United States
Facility Name
The Comprehensive Epilepsy Care Center for Children and Adults
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
St. Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Clinical Research Center of New Jersey (CRCNJ)
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14450
Country
United States
Facility Name
University Neurology, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Jefferson Epilepsy Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UTMG Pediatric Neurology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Children's Medical Center at UT Southwestern-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Cook Children's Health Care System
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine Pediatric Neurology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0211
Country
United States
Facility Name
Strategic Health Evaluators
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Royal Melbourne Hospital Department of Neurology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Vitebsk Regional Diagnostic Center
City
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Neurology Center
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
St. John's Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Malikatta Neuro Center
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
K. S. Hedge Medical Academy
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India
Facility Name
Jaslok Hospital & Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
KEM Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 011
Country
India
Facility Name
Institute of Human Behaviour and Allied Sciences
City
Delhi
State/Province
New Delhi
ZIP/Postal Code
110095
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Center
City
Erandawane
State/Province
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Christian Medical College
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
1410108
Country
India
Facility Name
Dr. Kamakshi Memorial Hospital
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600 100
Country
India
Facility Name
Chhatrapati Sahu Ji Maharaj Medical University
City
Lucknow
State/Province
Uttra Pradesh
ZIP/Postal Code
226 003
Country
India
Facility Name
Apollo Gleneagles Hospitals
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
P.D. Hinduja National Hospital Medical Research Centre
City
Mumbai
ZIP/Postal Code
400016
Country
India
Facility Name
Kaunas University of Medicine Hospital
City
Kaunas
ZIP/Postal Code
LT 50009
Country
Lithuania

12. IPD Sharing Statement

Citations:
PubMed Identifier
21956725
Citation
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.
Results Reference
result
PubMed Identifier
33825230
Citation
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.
Results Reference
derived
PubMed Identifier
27683846
Citation
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.
Results Reference
derived

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Clobazam in Patients With Lennox-Gastaut Syndrome

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