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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02201251




Registration number
NCT02201251
Ethics application status
Date submitted
24/07/2014
Date registered
28/07/2014
Date last updated
3/05/2023

Titles & IDs
Public title
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
Scientific 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
Secondary ID [1] 0 0
TOPMATEPY4067
Secondary ID [2] 0 0
CR104425
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Topiramate
Treatment: Drugs - Levetiracetam

Experimental: Topiramate - Topiramate weight based dosing for participants 2 to less than (\<) 10 years of age not to exceed 350 mg/day (milligram per day), as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.

Active comparator: Levetiracetam - Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 milligram per kilogram per day (mg/kg/day), as tolerated. The maximum recommended daily dosage is 3,000 milligram (mg).


Treatment: Drugs: Topiramate
Topiramate weight based dosing for participants 2 to \<10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.

Treatment: Drugs: Levetiracetam
Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Weight Z-score up to Month 1
Timepoint [1] 0 0
Baseline up to Month 1
Primary outcome [2] 0 0
Change From Baseline in Weight Z-score up to Month 3
Timepoint [2] 0 0
Baseline up to Month 3
Primary outcome [3] 0 0
Change From Baseline in Weight Z-score up to Month 6
Timepoint [3] 0 0
Baseline up to Month 6
Primary outcome [4] 0 0
Change From Baseline in Weight Z-score up to Month 9
Timepoint [4] 0 0
Baseline up to Month 9
Primary outcome [5] 0 0
Change From Baseline in Weight Z-score up to Month 12
Timepoint [5] 0 0
Baseline up to Month 12
Primary outcome [6] 0 0
Change From Baseline in Height Z-score up to Month 1
Timepoint [6] 0 0
Baseline up to Month 1
Primary outcome [7] 0 0
Change From Baseline in Height Z-score up to Month 3
Timepoint [7] 0 0
Baseline up to Month 3
Primary outcome [8] 0 0
Change From Baseline in Height Z-score up to Month 6
Timepoint [8] 0 0
Baseline up to Month 6
Primary outcome [9] 0 0
Change From Baseline in Height Z-score up to Month 9
Timepoint [9] 0 0
Baseline up to Month 9
Primary outcome [10] 0 0
Change From Baseline in Height Z-score up to Month 12
Timepoint [10] 0 0
Baseline up to Month 12
Primary outcome [11] 0 0
Change From Baseline in Bone Mineral Density (BMD) Z-score up to Month 6
Timepoint [11] 0 0
Baseline up to Month 6
Primary outcome [12] 0 0
Change From Baseline in BMD Z-score up to Month 12
Timepoint [12] 0 0
Baseline up to Month 12
Primary outcome [13] 0 0
Change From Baseline in Bone Mineral Content (BMC)-Z Score up to Month 6
Timepoint [13] 0 0
Baseline up to Month 6
Primary outcome [14] 0 0
Change From Baseline in BMC-Z Score up to Month 12
Timepoint [14] 0 0
Baseline up to Month 12
Secondary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Timepoint [1] 0 0
Up to Day 390
Secondary outcome [2] 0 0
Percentage of Participants With Kidney Stones
Timepoint [2] 0 0
Up to Day 390

Eligibility
Key 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
Minimum age
2 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2020
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Queensland
Recruitment postcode(s) [1] 0 0
- Queensland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Cordoba
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Namur
Country [13] 0 0
Canada
State/province [13] 0 0
Saskatchewan
Country [14] 0 0
France
State/province [14] 0 0
Brest
Country [15] 0 0
France
State/province [15] 0 0
Bron
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Germany
State/province [18] 0 0
Munchen
Country [19] 0 0
Germany
State/province [19] 0 0
Tübingen
Country [20] 0 0
Hungary
State/province [20] 0 0
Balassagyarmat
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest N/a
Country [22] 0 0
Hungary
State/province [22] 0 0
Debrecen
Country [23] 0 0
Hungary
State/province [23] 0 0
Veszprém
Country [24] 0 0
Philippines
State/province [24] 0 0
Cebu
Country [25] 0 0
Philippines
State/province [25] 0 0
Manila
Country [26] 0 0
Poland
State/province [26] 0 0
Krakow
Country [27] 0 0
Poland
State/province [27] 0 0
Poznan
Country [28] 0 0
Poland
State/province [28] 0 0
Warsaw
Country [29] 0 0
Poland
State/province [29] 0 0
Warszawa
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Saint Petersburg
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Ulyanovsk
Country [32] 0 0
South Africa
State/province [32] 0 0
Durban
Country [33] 0 0
Taiwan
State/province [33] 0 0
Kaohsiung
Country [34] 0 0
Taiwan
State/province [34] 0 0
New Taipei City
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02201251