Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

Phase 4

Completed

• Conditions: Behavior Problem; Epilepsy; Pyridoxine
• Interventions: Drug: Placebo; Drug: Pyridoxine

• Registration Number: NCT05008354
• Lead Sponsor: Nasim Tabrizi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-17
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pyridoxine	Pyridoxine	-

Primary Outcome Measures

Name	Time	Method
Behavioral side effects	3 weeks	Behavioral side effects are measured by SCL-90-R questionnaire

Trial Locations

Locations (1)

Bu Ali Sina Hospital; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of