Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05008354

Acronym

EPYLEB

Enrollment

Registered

2021-08-17

Start date

2020-10-01

Completion date

2021-09-01

Last updated

2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior Problem, Epilepsy, Pyridoxine

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.

Interventions

DRUGPyridoxine

Pyridoxine tablet 40mg once daily

DRUGPlacebo

Placebo tablet once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Behavioral side effects	3 weeks	Behavioral side effects are measured by SCL-90-R questionnaire

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026