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Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

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: NCT03940326
Recruitment Status : Completed
First Posted : May 7, 2019
Results First Posted : February 17, 2022
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Nasim Tabrizi, Mazandaran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy, Idiopathic Generalized Drug: Levetiracetam Drug: Valproate Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arms and Interventions
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Arm Intervention/treatment
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Seizure [ Time Frame: 6 months ]
    The time interval from the beginning of the study to occurrence of the first seizure

  2. Seizure Freedom Rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Withdrawal Rate [ Time Frame: 6 months ]
  2. Time to Withdrawal [ Time Frame: 9 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Age≥16
  • At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
  • Normal brain MRI or MRI without epileptogenic lesion
  • Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
  • Signing consent form

Exclusion Criteria:

  • History of treatment by sodium valproate or levetiracetam
  • History of treatment by any anti-epileptic drug in last 6 months
  • Plan for pregnancy
  • Using no certain contraceptive method
  • History of past or current hepatic disease
  • History of past or current renal disease
  • History of past or current hematologic disease
  • History of known psychiatric disease
  • History of status epilepticus
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940326


Locations
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Iran, Islamic Republic of
Bu Ali Sina Hospital
Sari, Mazandaran, Iran, Islamic Republic of, 4815837477
Sponsors and Collaborators
Mazandaran University of Medical Sciences
Investigators
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Principal Investigator: Nasim Tabrizi, MD Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.
  Study Documents (Full-Text)

Documents provided by Nasim Tabrizi, Mazandaran University of Medical Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] November 8, 2020

More Information
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Responsible Party: Nasim Tabrizi, Assistant professor of neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03940326    
Other Study ID Numbers: LEVIGS
First Posted: May 7, 2019    Key Record Dates
Results First Posted: February 17, 2022
Last Update Posted: February 17, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Levetiracetam
Valproic Acid
Anticonvulsants
Nootropic Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs