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

Nasim Tabrizi

Status and phase: Completed; Phase 4

Conditions: Behavior Problem; Epilepsy; Pyridoxine

Treatments: Drug: Placebo; Drug: Pyridoxine

Study type: Interventional

Funder types: Other

Identifiers

NCT05008354

5238

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups, including a placebo group

Pyridoxine

Active Comparator group

Treatment:

Drug: Pyridoxine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo