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Trial record 10 of 40 for:    CARBAMAZEPINE AND Valproic Acid

A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy

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.
 
ClinicalTrials.gov Identifier: NCT00236717
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE September 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
Time to first seizure from Day 15 of the study
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Time to first seizure from Day 15 of the study.
Change History Complete list of historical versions of study NCT00236717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
Official Title  ICMJE TOPAMAX (Topiramate) Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy (RWJ-17021-000); Phase IIIB
Brief Summary The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.
Detailed Description Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate (100 or 200mg per day) compared with standard antiepileptic drugs (carbamazepine or valproate) in patients with newly diagnosed epilepsy. The study is composed of three phases: baseline (up to 7 days), double-blind treatment, and a blinded extension. The double-blind phase is divided into two periods: titration, in which the dose of drug is gradually increased (approximately 35 days), and stabilization (of variable duration, with regular scheduled visits up to 92 days and then every 3 months thereafter). The dose of study drug remains constant during the stabilization period. In the blinded extension, patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion (patient unaware of identity of the drug). This phase continues until the patient leaves the study or the data base for the double blind phase is finalized. The primary assessment of effectiveness is the time to first seizure from Day 15 of the study. Safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology and biochemistry), measurements of vital signs and body weight, and physical examination findings. The study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated. Oral topiramate (25milligram [mg] or 50mg capsules or tablets),starting at 25mg/day (Week 1),increasing to 100mg or 200mg/day (Week 5).Increasing carbamazepine to 600mg/day or valproate to 1250mg/day (Week 5).Maximum dosages continue for a variable time and then taper over 4 weeks to starting dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Seizures
Intervention  ICMJE Drug: Topiramate; Carbamazepine; Valproate
Study Arms  ICMJE Not Provided
Publications * Wheless JW, Neto W, Wang S; EPMN-105 Study Group. Topiramate, carbamazepine, and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. J Child Neurol. 2004 Feb;19(2):135-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2011)
865
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
600
Actual Study Completion Date  ICMJE November 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body weight of at least 30 kilograms
  • New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry
  • No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks
  • Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry

Exclusion Criteria:

  • Patients who do not have epilepsy
  • Have progressive or degenerative disorders (for example, certain hereditary conditions)
  • Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)
  • Have mental retardation or other condition that could make interpretation of the study results difficult
  • alcohol or drug abuse within the previous year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00236717
Other Study ID Numbers  ICMJE CR005461
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP