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.
Sponsor:
Collaborators:
Parke-Davis
Glaxo Wellcome
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007670
First received: December 29, 2000
Last updated: January 20, 2009
Last verified: February 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: CSP #428 - Treatment of Seizures in the Elderly Population

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vamc - West Los Angeles, Los Angeles, Ca
Los Angeles, California, United States, 90073
Vamc - San Diego, San Diego, Ca
San Diego, California, United States, 92161
San Francisco VAMC
San Francisco, California, United States, 94121
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
United States, Florida
Vamc - Bay Pines, Fl
Bay Pines, Florida, United States, 33744
Gainesville VA Medical Center
Gainesville, Florida, United States, 32608-1197
Miami VA Medical Center
Miami, Florida, United States, 33125
Study Chairperson
Miami, Florida, United States, 33125
United States, Illinois
Chicago VA Medical Center (West Side)
Chicago, Illinois, United States, 60612
Edward Hines Jr. VA Hospital
Hines, Illinois, United States, 60141
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
Parke-Davis
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007670     History of Changes
Other Study ID Numbers: 428
Study First Received: December 29, 2000
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Carbamazepine
Lamotrigine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on October 16, 2014