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CompletedNCT05008354EPYLEBUpdated Mar 29, 2022

Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

A Phase 4 interventional study of Pyridoxine and Placebo in Epilepsy, Pyridoxine and Behavior Problem, sponsored by Nasim Tabrizi. Completed at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Nasim Tabrizi · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2020, registered Aug 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy
  • Pyridoxine
  • Behavior Problem
03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 1,228 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Nasim Tabrizi is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Pyridoxine

    Drug: Pyridoxine

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPyridoxine

    Pyridoxine tablet 40mg once daily

  • DrugPlacebo

    Placebo tablet once daily

06

What researchers measure

Primary outcomes

  1. Behavioral side effects

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

    Time frame: 3 weeks

07

Study locations

1 site
  • Bu Ali Sina Hospital
    Sari, Mazandaran 4815837477, Iran
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05008354
Lead sponsor
Nasim Tabrizi
Collaborators
Mazandaran University of Medical Sciences
Responsible party
Nasim Tabrizi (Associate professor of neurology, Mazandaran University of Medical Sciences) — Sponsor-investigator
First posted
Aug 17, 2021
Start date
Oct 1, 2020
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Mar 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Pyridoxine

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