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NCT05008354 Clinical Trial

Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

Epilepsy Clinical Trial

— EPYLEB  

Official title:
Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05008354
Other study ID # 5238
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2020
Est. completion date September 1, 2021

Study information
Verified date March 2022
Source Mazandaran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Bu Ali Sina Hospital Sari Mazandaran

Sponsors (2)
Lead Sponsor Collaborator
Nasim Tabrizi Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Behavioral side effects Behavioral side effects are measured by SCL-90-R questionnaire 3 weeks
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