DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Topiramate (Drug); Levetiracetam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Summary

The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.

Clinical Details

Official title: A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Percentage of Participants With Kidney Stones

Change From Baseline in Weight Z-score at Month 12

Height at Month 12

Change From Baseline in Height at Month 12

Height Z-score at Month 12

Change From Baseline in Height Z-score at Month 12

Height Velocity (HV) at Month 12

Height Velocity (HV) Z-score at Month 12

Percentage of Outlier Participants

Bone Mineral Density (BMD)

Bone Mineral Content (BMC)

Change From Baseline in Bone Mineral Density (BMD) at Month 12

Change From Baseline in Bone Mineral Content (BMC) at Month 12

Bone Mineral Density (BMD)-Z Score

Bone Mineral Content (BMC) Z-Score

Change From Baseline in Bone Mineral Density (BMD)-Z Score at Month 12

Change From Baseline in Bone Mineral Content (BMC) Z-Score at Month 12

Percent Change From Baseline in Bone Mineral Density (BMD) at Month 12

Percent Change From Baseline in Bone Mineral Content (BMC) at Month 12

Percentage of Outlier Participants with BMD Z-score

Change From Baseline in Biochemical Markers at Month 12

Change From Baseline in Serum Laboratory Tests at Month 12

Change From Baseline in Bone Age at Month 12

Secondary outcome:

Change From Baseline in Weight Z-score at Month 1, 3, 6 and 9

Change From Baseline in Height at Month 1, 3, 6 and 9

Change From Baseline in Height Z-score at Month 1, 3, 6 and 9

Percentage of Outlier Participants

Bone Mineral Density (BMD)

Bone Mineral Content (BMC)

Change From Baseline in Bone Mineral Density (BMD) at Month 6

Change From Baseline in Bone Mineral Content (BMC) at Month 6

Bone Mineral Density (BMD)-Z Score

Bone Mineral Content (BMC) Z-Score

Change From Baseline in Bone Mineral Density (BMD)-Z Score at Month 6

Change From Baseline in Bone Mineral Content (BMC) Z-Score at Month 6

Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6

Percent Change From Baseline in Bone Mineral Content (BMC) at Month 6

Percentage of Outlier Participants with BMD Z-score

Change From Baseline in Biochemical Markers at Month 6

Change From Baseline in Serum Laboratory Tests at Month 1, 3, 6 and 9

Detailed description: This is a randomized (study medication assigned to participants by chance), open-label, multi-centric (conducted in more than one center) and 2-arm flexible-dose monotherapy study of topiramate compared with 1 another AED (levetiracetam) in pediatric participants with epilepsy. The total study duration will be up to of 1 year and 2 months per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1); Treatment (1 year) and post-treatment (30 days). Safety will primarily be evaluated by percentage of participants with kidney stones and change from baseline in bone mineral density at Month 12.

Eligibility

Minimum age: 2 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant with a clinical diagnosis of new-onset or recent-onset epilepsy

characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening

- Caregivers (parents or legally acceptable representatives) of the participant must be

able to accurately maintain the participant take-home record and seizure diary

- At screening, participant must have weight and height values within the

5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])

- Participant must never have been treated for epilepsy (treatment-naïve) or have been

treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment

- Parents (or legally acceptable representatives) of the participant must sign

an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation Exclusion Criteria:

- Participant has a surgically implanted and functioning vagus nerve stimulator

- Participant has a history of seizures as a result of a correctable medical condition,

such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening

- Participant has had uncontrolled seizures while previously taking either

topiramate or levetiracetam

- Participant has a history of non-epileptic seizures within 2 weeks prior to

the first day of Screening

- Participant has myoclonic or absence seizures

Locations and Contacts

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Buenos Aires, Argentina; Not yet recruiting

La Plata, Buenos Aires, Argentina; Not yet recruiting

Bregenz, Austria; Not yet recruiting

Graz, Austria; Not yet recruiting

Brussels, Belgium; Not yet recruiting

Leuven, Belgium; Not yet recruiting

Namur, Belgium; Not yet recruiting

Changchun, China; Not yet recruiting

Chengdu, China; Not yet recruiting

Guangzhou, China; Not yet recruiting

Shanghai, China; Not yet recruiting

Amiens, France; Withdrawn

Brest, France; Not yet recruiting

Bron, France; Not yet recruiting

Paris, France; Not yet recruiting

Toulouse, France; Not yet recruiting

Berlin, Germany; Withdrawn

Munchen, Germany; Not yet recruiting

Tübingen, Germany; Not yet recruiting

Balassagyarmat, Hungary; Not yet recruiting

Budapest N/A, Hungary; Not yet recruiting

Debrecen, Hungary; Recruiting

Veszprém, Hungary; Recruiting

Daegu, Korea, Republic of; Not yet recruiting

Seoul, Seoul Teugbyeolsi, Korea, Republic of; Not yet recruiting

Seoul, Korea, Republic of; Not yet recruiting

Morelia, Mexico; Not yet recruiting

Cebu, Philippines; Not yet recruiting

Manila, Philippines; Not yet recruiting

Quezon City, Philippines; Not yet recruiting

Krakow, Poland; Not yet recruiting

Poznan, Poland; Not yet recruiting

Warszawa, Poland; Not yet recruiting

Saint Petersburg, Russian Federation; Not yet recruiting

Ulyanovsk, Russian Federation; Recruiting

Voronezh, Russian Federation; Not yet recruiting

Yaroslavl, Russian Federation; Not yet recruiting

Durban, South Africa; Not yet recruiting

Mthatha, South Africa; Not yet recruiting

Sevilla, Spain; Not yet recruiting

Kaohsiung, Taiwan; Not yet recruiting

New Taipei City, Taiwan; Not yet recruiting

Taichung, Taiwan; Not yet recruiting

Taipei, Taiwan; Not yet recruiting

Taoyuan, Taiwan; Not yet recruiting

London, United Kingdom; Not yet recruiting

Birmingham, Alabama, United States; Recruiting

Calgary, Alberta, Canada; Not yet recruiting

Tucson, Arizona, United States; Not yet recruiting

Los Angeles, California, United States; Not yet recruiting

Gainesville, Florida, United States; Not yet recruiting

Gulf Breeze, Florida, United States; Not yet recruiting

Orlando, Florida, United States; Recruiting

Tampa, Florida, United States; Not yet recruiting

Wellington, Florida, United States; Recruiting

Augusta, Georgia, United States; Not yet recruiting

Iowa City, Iowa, United States; Not yet recruiting

Louisville, Kentucky, United States; Not yet recruiting

Boston, Massachusetts, United States; Not yet recruiting

Detroit, Michigan, United States; Not yet recruiting

Valhalla, New York, United States; Not yet recruiting

Chapel Hill, North Carolina, United States; Not yet recruiting

Durham, North Carolina, United States; Not yet recruiting

Columbus, Ohio, United States; Not yet recruiting

Toledo, Ohio, United States; Not yet recruiting

Portland, Oregon, United States; Not yet recruiting

Philadelphia, Pennsylvania, United States; Not yet recruiting

Saskatoon, Saskatchewan, Canada; Not yet recruiting

Nashville, Tennessee, United States; Not yet recruiting

San Antonio, Texas, United States; Recruiting

Temple, Texas, United States; Not yet recruiting

Salt Lake City, Utah, United States; Not yet recruiting

Seattle, Washington, United States; Not yet recruiting

Madison, Wisconsin, United States; Not yet recruiting

Additional Information

To learn how to participate in this trial please click here.

Starting date: September 2014
Last updated: August 7, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017