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出境医 / 临床实验 / Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Study Description
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
Arms and Interventions
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
Primary Outcome Measures :
  1. Time to first seizure [ Time Frame: 1 year ]
  2. Seizure freedom rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Withdrawal rate [ Time Frame: 1 year ]
  2. Time to withdrawal [ Time Frame: 1 year ]

Eligibility Criteria
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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

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.
Tracking Information
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
 (submitted: May 4, 2019)
  • Time to first seizure [ Time Frame: 1 year ]
  • Seizure freedom rate [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
  • Withdrawal rate [ Time Frame: 1 year ]
  • Time to withdrawal [ Time Frame: 1 year ]
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
Condition  ICMJE Epilepsy, Idiopathic Generalized
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Levetiracetam
    Intervention: Drug: Levetiracetam
  • Active Comparator: Valproate
    Intervention: Drug: Valproate
Publications * Not Provided

*   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: August 11, 2020) 		103
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2019) 		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nasim Tabrizi, Mazandaran University of Medical Sciences
Study Sponsor  ICMJE Mazandaran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nasim Tabrizi, MD Neurology department, Mazandaran University of Medical Sciences, Sari, Iran.
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

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