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EPYLEB: Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

Sponsor
Nasim Tabrizi (Other)
Overall Status
Completed
CT.gov ID
NCT05008354
Collaborator
Mazandaran University of Medical Sciences (Other)
30
Enrollment
1
Location
2
Arms
11
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a two-arm parallel group randomized double-blind placebo-controlled trial with the aim of Investigating pyridoxine effect on behavioral side effects of levetiracetam in adult patients with epilepsy.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pyridoxine

Drug: Pyridoxine
Pyridoxine tablet 40mg once daily
Placebo Comparator: Placebo

Drug: Placebo
Placebo tablet once daily

Outcome Measures

Primary Outcome Measures

  1. Behavioral side effects [3 weeks]

    Behavioral side effects are measured by SCL-90-R questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Ageā‰„18 years

  • Patients with epilepsy

  • Patients who are treated by levetiracetam (Levebel, Cobel darou) in recent month

  • Complaint of behavioral problem

  • Patient's consent for participation

Exclusion Criteria:

  • History of known psychiatric disease

  • Pregnancy

  • Incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt

  • Treatment with psychiatric medications

  • Alcohol or drug abuse

  • Mental retardation to the degree that intervenes comprehension and response to questionnaire

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bu Ali Sina Hospital Sari Mazandaran Iran, Islamic Republic of 4815837477

Sponsors and Collaborators

  • Nasim Tabrizi
  • Mazandaran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nasim Tabrizi, Associate professor of neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05008354
Other Study ID Numbers:
  • 5238
First Posted:
Aug 17, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Epilepsy
Problem Behavior
Pyridoxine

Study Results

No Results Posted as of Mar 29, 2022