NCT05008354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

August 10, 2021

Last Update Submit

March 28, 2022

Conditions

EpilepsyPyridoxineBehavior Problem

Outcome Measures

Primary Outcomes (1)

  • Behavioral side effects

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

    3 weeks

Study Arms (2)

Pyridoxine

ACTIVE COMPARATOR
Drug: Pyridoxine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PyridoxineDRUG

Pyridoxine tablet 40mg once daily

Pyridoxine
PlaceboDRUG

Placebo tablet once daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bu Ali Sina Hospital

Sari, Mazandaran, 4815837477, Iran

Location

MeSH Terms

Conditions

EpilepsyMental Disorders

Interventions

Pyridoxine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 6PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor of neurology

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 17, 2021

Study Start

October 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)