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Effect of pyridoxine on behavioral side effects of levetiracetam

Investigation of pyridoxine effect on behavioral adverse events of levetiracetam in adult patients with idiopathic generalized tonic-clonic epilepsy; A randomized double-blind placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180406039205N1
Enrollment
50
Registered
2019-12-28
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

Epilepsy. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention Pyridoxine, 40mg tablet (Darou pakhsh, Iran) once daily. Intervention 2: Control group: Placebo tablet with the same shape and color as pyridoxine, once daily.

Sponsors

Sari University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >=18 years Patients affected by idiopathic generalized 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

Design outcomes

Primary

MeasureTime frame
Efficacy of pyridoxine in treatment of behavioral side effects. Timepoint: before intervention and 3 weeks after intervention. Method of measurement: Symptom checklist-90-revised (SCL-90-R) questionnaire.;Withdrawal rate of levetiracetam due to behavioral side effects. Timepoint: 3 weeks. Method of measurement: Patient interview.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Tabrizi

Sari University of Medical Sciences

nasimtabrizi@gmail.com+98 11 3334 3015

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026