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Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam (EPYLEB)

Primary Purpose

Epilepsy, Pyridoxine, Behavior Problem

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pyridoxine
Placebo
Sponsored by
Nasim Tabrizi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bu Ali Sina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pyridoxine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 10, 2021
Last Updated
March 28, 2022
Sponsor
Nasim Tabrizi
Collaborators
Mazandaran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05008354
Brief Title
Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam
Acronym
EPYLEB
Official Title
Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nasim Tabrizi
Collaborators
Mazandaran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Pyridoxine, Behavior Problem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyridoxine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pyridoxine
Intervention Description
Pyridoxine tablet 40mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet once daily
Primary Outcome Measure Information:
Title
Behavioral side effects
Description
Behavioral side effects are measured by SCL-90-R questionnaire
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bu Ali Sina Hospital
City
Sari
State/Province
Mazandaran
ZIP/Postal Code
4815837477
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

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