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

Primary Purpose

Epilepsy, Epilepsies, Partial, Epilepsy, Generalized

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
topiramate
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Partial Epilepsy, Secondary Generalized Epilepsy, Primary Generalized Epilepsy, Tonic-Clonic Seizures, Topiramate, Weight Loss

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    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

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    April 26, 2010
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236886
    Brief Title
    Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2000 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Epilepsies, Partial, Epilepsy, Generalized, Seizures
    Keywords
    Epilepsy, Partial Epilepsy, Secondary Generalized Epilepsy, Primary Generalized Epilepsy, Tonic-Clonic Seizures, Topiramate, Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12690085
    Citation
    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.
    Results Reference
    result

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

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