Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

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.

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Key information

Conditions

Epilepsy Behavior Problem Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Pyridoxine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pyridoxine

Drug

Pyridoxine tablet 40mg once daily

Placebo

Drug

Placebo tablet once daily

Primary outcomes

Behavioral side effects

Time frame: 3 weeks

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

Sponsors and collaborators

Lead sponsor

Nasim Tabrizi

Other

Collaborators

Mazandaran University of Medical Sciences

Registry information

Official study title

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

Acronym: EPYLEB

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Aug 17, 2021
Registry last updated: Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed