Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

Overview

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.

Full Title of Study: “Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2021

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Pyridoxine
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Behavioral side effects
    • Time Frame: 3 weeks
    • Behavioral side effects are measured by SCL-90-R questionnaire

Participating in This Clinical Trial

Inclusion Criteria

  • Age≥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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nasim Tabrizi
  • Collaborator
    • Mazandaran University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Nasim Tabrizi, Associate professor of neurology – Mazandaran University of Medical Sciences

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