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Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236886
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : April 28, 2010
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.

Condition or disease Intervention/treatment Phase
Epilepsy Epilepsies, Partial Epilepsy, Generalized Seizures Drug: topiramate Phase 3

Detailed Description:
Topiramate has been shown to be an effective anti-epileptic medication with a good safety profile. In clinical trials, some patients have experienced substantial weight loss. This prospective single center, open, pilot study will investigate whether there is any metabolic predictor for the weight loss. The patients will receive daily oral dose of topiramate in addition to anti-epileptic medications already prescribed by their physicians. A battery of metabolic tests including Body Mass Index (BMI), lean body mass, blood lipids and fasting glucose in tandem with other examinations will be taken before dispensing of topiramate, after 3 months and at the final visit. The study hypothesis is metabolic test results will provide a predictor of weight loss with topiramate. Patients will receive between 25 to 400mg daily of topiramate by mouth in addition to current anti-epileptic medications for up to 1 year. Dose will be adjusted (up to 1000 mg daily) by the investigators depending on the patients' clinical response.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Pilot Study on Metabolism and Weight Changes in Subjects With Diagnosed Partial Onset Epilepsy, With or Without Secondarily Generalized Seizures and Treated With Topiramate.
Study Start Date : May 1998
Actual Study Completion Date : June 2000

Primary Outcome Measures :
  1. Metabolic test battery including Body Mass Index (BMI), lean body mass, blood lipids and fasting glucose along with physical examinations (including body weights) will be recorded at the beginning of the trial, after 3 months and after one year

Secondary Outcome Measures :
  1. Safety evaluations (vital signs, physical exams, electrocardiogram, incidence and severity of adverse events) will be conducted throughout the study; Seizure frequency will be monitored throughout the study

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of partial onset epilepsy, with or without secondary generalization. Patients with a diagnosis of epilepsy characterized by primary generalized tonic-clonic seizures may also qualify
  • Currently taking one or more anti-epileptic medications on a stable dose for one month
  • Weight between 40 and 130 kg (88 to 286 lbs)
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test).

Exclusion Criteria:

  • Patients with rapidly progressive disorders that may impair their weight or their reliable participation in the study
  • Patients prone to severe malabsorption and/or metabolic disorders
  • Patients who have mental retardation or impairment which would confound the interpretation of this study
  • History (within the past six months) of a psychiatric or mood disorder requiring medical treatment
  • History of poor compliance with past anti-epileptic drug therapy
  • Suicide attempt in the past five years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236886

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publications of Results:
Layout table for additonal information Identifier: NCT00236886    
Other Study ID Numbers: CR003703
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Partial Epilepsy
Secondary Generalized Epilepsy
Primary Generalized Epilepsy
Tonic-Clonic Seizures
Weight Loss
Additional relevant MeSH terms:
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Epilepsies, Partial
Epilepsy, Generalized
Body Weight Changes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Body Weight
Hypoglycemic Agents
Physiological Effects of Drugs