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

NCT00236886 | Completed Phase 3

• 1 other identifier: CR003703
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy; Epilepsies, Partial; Epilepsy, Generalized; Seizures

Keywords

Epilepsy; Partial Epilepsy; Secondary Generalized Epilepsy; Primary Generalized Epilepsy; Tonic-Clonic Seizures; Topiramate; Weight Loss

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• 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.

  PMID: 12690085 RESULT

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Epilepsy, Generalized; Seizures; Epilepsy, Idiopathic Generalized; Weight Loss

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 1998
• Study Completion: June 1, 2000
• Last Updated: April 28, 2010

Record last verified: 2010-04