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Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug



Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

For Condition: Epilepsy
Status: No longer recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic seizures.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: (All of these criteria must be met in order to be eligible to participate in the study) - Weigh at least 13kg. - Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types. - Currently being treated with an antiepileptic drug(s) (AED). - Benzodiazepines are allowed with some frequency restrictions. - Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study. - History of primary generalized tonic-clonic seizures with no focal onset. - Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study. - Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study. - Females must agree to acceptable form of birth control. EXCLUSION CRITERIA: (None of these criteria can be met in order to be eligible to participate in this study) - A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram. - Have Lennox-Gastaut syndrome. - Currently using or has previously used the drug being studied. - Is abusing alcohol and/or other substance(s). - Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study. - Is receiving chronic (long-term) treatment with any medication that could influence seizure control. - Follows the ketogenic diet. - Is planning surgery to control seizures during the study. - Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality. - Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
Total Enrollment: 

Location and Contact Information:

Study Site
Natrona Heights,  Pennsylvania,  15065
United States
 

Study Site
Chicago,  Illinois,  60637
United States
 

Study Site
Atlanta,  Georgia,  30341
United States
 

Study Site
Lima,  ,  27
Peru
 

Study Site
Seattle,  Washington,  98104
United States
 

Study Site
Augusta,  Georgia,  30912
United States
 

Study Site
Idaho Falls,  Idaho,  83404
United States
 

Study Site
Newport News,  Virginia,  23601
United States
 

Study Site
Canton,  Ohio,  44718
United States
 

Study Site
Medford,  New Jersey,  08055
United States
 

Study Site
St. Cloud,  Minnesota,  56303
United States
 

Study Site
Salt Lake City,  Utah,  84111
United States
 

Study Site
Ft. Worth,  Texas,  76104
United States
 

Study Site
Winston Salem,  North Carolina,  27157
United States
 

Study Site
Danville,  Virginia,  24541
United States
 

Study Site
Atlanta,  Georgia,  30338
United States
 

Study Site
Wilmington,  Delaware,  19806
United States
 

Study Site
Raleigh,  North Carolina,  27607
United States
 

Study Site
Little Rock,  Arkansas,  72205
United States
 

Study Site
Washington D.C.,  District of Columbia,  20037
United States
 

Study Site
Bennington,  Vermont,  05201
United States
 

Study Site
Sharon,  Massachusetts,  02067
United States
 

Study Site
Sacramento,  California,  95817
United States
 

Study Site
Tacoma,  Washington,  98405
United States
 

Study Site
Nashville,  Tennessee,  37212
United States
 

Study Site
Santiago,  ,  Lira 44
Chile
 

Study Site
Miami,  Florida,  33125
United States
 

Study Site
Baltimore,  Maryland,  21201
United States
 

Study Site
Newton,  Massachusetts,  02459
United States
 

Study Site
Bakersfield,  California,  93309
United States
 

Study Site
Danville,  Pennsylvania,  17822
United States
 

Study Site
Spartanburg,  South Carolina,  29303
United States
 

Study Site
Oklahoma City,  Oklahoma,  73104
United States
 

Study Site
Las Vegas,  Nevada,  89102
United States
 

Study Site
Greenville,  North Carolina,  27834
United States
 

Study Site
Medforo,  Oregon,  97504
United States
 

Study Site
San Antonio,  Texas,  78258
United States
 

Study Site
New Brunswick,  New Jersey,  08901
United States
 

Study Site
Marshfield,  Wisconsin,  54449
United States
 

Study Site
Cleveland,  Ohio,  44195
United States
 

Study Site
Northridge,  California,  91325
United States
 

Study Site
Elkhart,  Indiana,  46514
United States
 

Study Site
Wichita,  Kansas,  67214
United States
 

Study Site
Asheville,  North Carolina,  28803
United States
 

Study Site
Panama City,  Florida,  32405
United States
 

Study Site
St. Louis,  Missouri,  63110
United States
 

Study Site
Salt Lake City,  Utah,  84113
United States
 

Study Site
Dallas,  Texas,  75390
United States
 

Study Site
Memphis,  Tennessee,  38119
United States
 

Study Site
Valparaiso,  ,  725
Chile
 

Study Site
Denver,  Colorado,  80218
United States
 

Study Site
Cherry Hill,  New Jersey,  08034
United States
 

Study Site
Indianapolis,  Indiana,  46202
United States
 

Study Site
Gurnee,  Illinois,  60031
United States
 

Study Site
Atlanta,  Georgia,  30322
United States
 

Study Site
Brownwood,  Texas,  76801
United States
 

Study Site
Cleveland,  Ohio,  44106
United States
 

Study Site
Miami,  Florida,  33136
United States
 

Study Site
Little Rock,  Arkansas,  72205
United States
 

Study Site
Springfield,  Missouri,  65807
United States
 

Study Site
Southfield,  Michigan,  48034
United States
 

Study Site
Madison,  Wisconsin,  53715
United States
 

Study Site
Lexington,  Kentucky,  40536
United States
 

Study Site
Boise,  Idaho,  83712
United States
 

Study Site
San Antonio,  Texas,  78229
United States
 

Study Site
Springfield,  Illinois,  62702
United States
 

Study Site
Crestview,  Kentucky,  41017
United States
 

Study Site
Memphis,  Tennessee,  38105
United States
 

Study Site
Kansas City,  Missouri,  64108
United States
 

Study Site
Orlando,  Florida,  32806
United States
 

Study Site
Golden Valley,  Minnesota,  55422
United States
 

Study Site
Stephenville,  Texas,  76401
United States
 

Study Site
Ft. Worth,  Texas,  76104
United States
 

Study Site
West Palm Beach,  Florida,  33407
United States
 

Study Site
San Antonio,  Texas,  78229
United States
 

Study Site
Mt. Vernon,  New York,  10550
United States
 

Study Site
Gainesville,  Florida,  32608
United States
 

Study Site
Alabaster,  Alabama,  35007
United States
 

Study Site
Northport,  Alabama,  35476
United States
 

Study Site
Gainesville,  Florida,  32610
United States
 

Study Site
Buenos Aires,  ,  C1428AQK
Argentina
 


Additional Information:
Study ID Numbers:
  LAM40097; 
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043901

Other Epilepsy Studies:
1. Ketogenic Diet for Child Epilepsy and Seizure Control

2. Monitoring Patients with Uncontrolled Epilepsy

3. Mapping the Areas of the Brain Associated with Language in Children with Epilepsy

4. Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy.

5. Functional Coupling of Cortico-Cortical and Cortico-Muscular Connections during Motor Movements: An Electrocorticographic Study of Ipsilateral Motor Control

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Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

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