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

NCT ID: NCT00236886

Last Updated: 2010-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2000-06-30

Brief Summary

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

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.

Conditions

Epilepsy; Epilepsies, Partial; Epilepsy, Generalized; Seizures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

topiramate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

Ben-Menachem E, Axelsen M, Johanson EH, Stagge A, Smith U. Predictors of weight loss in adults with topiramate-treated epilepsy. Obes Res. 2003 Apr;11(4):556-62. doi: 10.1038/oby.2003.78.

Reference Type: RESULT

PMID: 12690085 (View on PubMed)

Other Identifiers

CR003703

Identifier Type: -

Identifier Source: org_study_id