Prospective Pilot Study on Metabolism and Weight Changes... | NCT00236886

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

NCT00236886

Sponsor

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

Status

Completed

Last Update Posted

Apr 28, 2010Estimated

Enrollment

49Actual

Phase

Phase 3

Conditions

Epilepsy
Epilepsies, Partial
Epilepsy, Generalized
Seizures

Interventions

topiramate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1998

Primary Completion Date

Not provided

Completion Date

Jun 2000Actual

First Submitted Date

Oct 7, 2005

First Submission Date that Met QC Criteria

Oct 11, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2010

Last Update Posted Date

Apr 28, 2010Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Name	Type	Description	Arm Group Labels	Other Names
topiramate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12690085	Result	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.

ID	Term
D004827	Epilepsy
D004828	Epilepsies, Partial
D004829	Epilepsy, Generalized
D012640	Seizures
C562694	Epilepsy, Idiopathic Generalized
D015431	Weight Loss

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241