Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam
NCT ID: NCT05008354
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2020-10-01
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pyridoxine
Pyridoxine
Pyridoxine tablet 40mg once daily
Placebo
Placebo
Placebo tablet once daily
Interventions
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Pyridoxine
Pyridoxine tablet 40mg once daily
Placebo
Placebo tablet once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mazandaran University of Medical Sciences
OTHER
Nasim Tabrizi
OTHER
Responsible Party
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Nasim Tabrizi
Associate professor of neurology
Locations
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Bu Ali Sina Hospital
Sari, Mazandaran, Iran
Countries
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Other Identifiers
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5238
Identifier Type: -
Identifier Source: org_study_id
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