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Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly.

This study has been completed.

Sponsors and Collaborators: Department of Veterans Affairs
Parke-Davis
Glaxo Wellcome
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007670
  Purpose

New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.


Condition Intervention Phase
Seizures
Drug: Carbamazepine
Drug: Gabapentin
Drug: Lamotrigine
Phase III

Genetics Home Reference related topics:   pyridoxal 5'-phosphate-dependent epilepsy    pyridoxine-dependent epilepsy   

MedlinePlus related topics:   Seizures   

Drug Information available for:   Gabapentin    Lamotrigine    Carbamazepine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   CSP #428 - Treatment of Seizures in the Elderly Population

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   720
Study Start Date:   January 1998
Estimated Study Completion Date:   March 2003

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Veterans 60 years of age or older who have new onset, unprovoked seizures of focal onset, with or without secondary generalization.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007670

Locations
United States, Alabama
Birmingham VA Medical Center    
      Birmingham, Alabama, United States, 35233
United States, Arizona
Carl T. Hayden VA Medical Center    
      Phoenix, Arizona, United States, 85012
United States, California
San Francisco VAMC    
      San Francisco, California, United States, 94121
Vamc - San Diego, San Diego, Ca    
      SAN DIEGO, California, United States, 92161
Vamc - West Los Angeles, Los Angeles, Ca    
      Los Angeles, California, United States, 90073
United States, Colorado
Denver VA Medical Center    
      Denver, Colorado, United States, 80220
United States, Florida
Study Chairperson    
      Miami, Florida, United States, 33125
Gainesville VA Medical Center    
      Gainesville, Florida, United States, 32608-1197
Miami VA Medical Center    
      Miami, Florida, United States, 33125
Vamc - Bay Pines, Fl    
      Bay Pines, Florida, United States, 33744
United States, Illinois
Edward Hines Jr. VA Hospital    
      Hines, Illinois, United States, 60141
Chicago VA Medical Center (West Side)    
      Chicago, Illinois, United States, 60612
United States, Louisiana
New Orleans VAMC    
      New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston VA Medical Center    
      Boston, Massachusetts, United States, 02130
United States, New York
Study Chairman    
      Bronx, New York, United States, 10468
Bronx VA Medical Center    
      Bronx, New York, United States, 10468
United States, Oklahoma
Oklahoma City VA Medical Center    
      Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Vamc - Pittsburgh, Pittsburgh, Pa    
      Pittsburgh, Pennsylvania, United States, 15240-1001
United States, Texas
Dallas VA Medical Center    
      Dallas, Texas, United States, 75216
United States, Virginia
Hunter Holmes McGuire VA Medical Center    
      Richmond, Virginia, United States, 23249

Sponsors and Collaborators
Department of Veterans Affairs
Parke-Davis
Glaxo Wellcome
  More Information


Study ID Numbers:   428
First Received:   December 29, 2000
Last Updated:   February 2, 2007
ClinicalTrials.gov Identifier:   NCT00007670
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
gabapentin  
lamotrigine  
seizures in the elderly  
Carbamazepine  

Study placed in the following topic categories:
Excitatory Amino Acids
Signs and Symptoms
Carbamazepine
Gabapentin
Epilepsy
Seizures
Lamotrigine
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Antiparkinson Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 20, 2008




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