Condition or disease | Intervention/treatment | Phase |
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Epilepsy, Idiopathic Generalized | Drug: Levetiracetam Drug: Valproate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures |
Actual Study Start Date : | April 1, 2018 |
Actual Primary Completion Date : | October 1, 2019 |
Actual Study Completion Date : | December 1, 2019 |
Arm | Intervention/treatment |
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Experimental: Levetiracetam |
Drug: Levetiracetam
Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
Other Name: Levebel
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Active Comparator: Valproate |
Drug: Valproate
Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Bu Ali Sina Hospital | |
Sari, Mazandaran, Iran, Islamic Republic of, 4815837477 |
Principal Investigator: | Nasim Tabrizi, MD | Neurology department, Mazandaran University of Medical Sciences, Sari, Iran. |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 30, 2019 | ||||||
First Posted Date ICMJE | May 7, 2019 | ||||||
Last Update Posted Date | August 12, 2020 | ||||||
Actual Study Start Date ICMJE | April 1, 2018 | ||||||
Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures | ||||||
Official Title ICMJE | Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures | ||||||
Brief Summary | This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Epilepsy, Idiopathic Generalized | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
103 | ||||||
Original Estimated Enrollment ICMJE |
148 | ||||||
Actual Study Completion Date ICMJE | December 1, 2019 | ||||||
Actual Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 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 | Iran, Islamic Republic of | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03940326 | ||||||
Other Study ID Numbers ICMJE | LEVIGS | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Nasim Tabrizi, Mazandaran University of Medical Sciences | ||||||
Study Sponsor ICMJE | Mazandaran University of Medical Sciences | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Mazandaran University of Medical Sciences | ||||||
Verification Date | August 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |