Effects of Keppra on Thinking, Emotions, and Balance in Elderly Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospitals of Cleveland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Michael Schoenberg, Ignacio Pita, Kyra Dawson
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00221988
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Epilepsy is a common disorder with an incidence of about 6 per 1000. The incidence progressively increases above age 50. By age 75, the incidence is two to three fold compared with any age group. Unfortunately, older individuals are especially at risk to incur significant side effects to anti-epileptic drugs. A newer anti-epileptic drug may markedly improve seizure management in older individuals as it is removed by the kidneys and not the liver and does not interact with other medications. We expect it to be tolerated well in terms of effects on memory, thinking,balance, and walking. The current study assesses the side effects of levetiracetam in healthy volunteers aged 65 to 80. Use of healthy volunteers eliminates the effects of seizures on the outcome.


Condition Intervention
Epilepsy
Drug: Levetiracetam (Keppra)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Cross-Over Study of the Cognitive and Mood Effects of KEPPRA (Levetiracetam) Tablets in Healthy Older Adults.

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • 1.Objective Neuropsyhological testing
  • 2.Subjective Behavioral Measures
  • 3.Balance Measures

Estimated Enrollment: 40
Study Start Date: March 2004
Estimated Study Completion Date: September 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study Population Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply. A subject must:

  1. Provide a copy of their medical records from a primary care physician for the past year to assist in establishing the patient’s current health status. The study physician will review PCP medical records to assure participants meet the study inclusion/exclusion criteria.
  2. Be a healthy adult age 65 to 80 years old. Healthy subjects are defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychiatric disease as determined by history and physical examination.
  3. Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable.
  4. Subjects must score within –1.0 standard deviations of the mean performance of healthy individuals on the neuropsychological tests at screen (week –2). Subjects must have a reading equivalency of 8th grade. Participants must also have a MMSE score of 28. (Bravo & Herbert, 1997; Crum et al., 1993). Finally, participants must score a 45 or better on the Berg Balance Test at screening (week –2) to be included in the study.
  5. Sign an informed consent.
  6. For participants living alone, provide the name and number of at least one friend or family member that study personnel may contact in the unlikely event that study personnel are unable to contact the patient by phone past 48 hours of a scheduled phone contact time which was not planned.

Exclusion Criteria:

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply. A subject must not:

  1. Have a history of any type of epilepsy.
  2. Be taking any concomitant medications that are or any concomitant medications that may alter cognitive function or mood.
  3. Have a current or past history of drug or alcohol abuse or dependence. Have a positive urine toxicology test at screen.
  4. Have a history and clinical finding of a progressive encephalopathy including CNS tumors of all types.
  5. Have a serious illness in the past month that may confound the interpretation of study results.
  6. Be on anticoagulation with warfarin.
  7. Have experienced a prior adverse reaction or hypersensitivity to either study medication or to related compounds.
  8. Be currently participating in another clinical study in which the subject will be exposed to an investigational or a non-investigational drug or device.

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  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: NCT00221988

Contacts
Contact: Mary Ann Werz, M.D., Ph,D. 216-844-3717 maryann.werz@uhhs.com
Contact: Mike R Schoenberg, Ph.D. 216-844-5820 michael.schoenberg@uhhs.com

Locations
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mary Ann Werz, M.D., Ph.D.    216-844-3100    maryann.werz@uhhs.com   
Contact: Mary Ann Werz, M.D.    216-844-3717    maryann.werz@uhhs.com   
Principal Investigator: Mary Ann Werz, M.D., Ph.D.         
Principal Investigator: Mike R sCHOENBERG, Ph.D.         
Sponsors and Collaborators
University Hospitals of Cleveland
Michael Schoenberg, Ignacio Pita, Kyra Dawson
Investigators
Principal Investigator: Mary Ann Werz, M.D., Ph.D. University Hospitals of Cleveland
Principal Investigator: Mike R Schoenberg, Ph.D. University Hospitals of Cleveland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221988     History of Changes
Other Study ID Numbers: UCB MRS001, UHC 06-04-52
Study First Received: September 16, 2005
Last Updated: September 16, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Elderly
Epilepsy
Cognition
Health Outcome

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014