Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam
Overview
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.
Full Title of Study: “Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 1, 2021
Interventions
- Drug: Pyridoxine
- Pyridoxine tablet 40mg once daily
- Drug: Placebo
- Placebo tablet once daily
Arms, Groups and Cohorts
- Active Comparator: Pyridoxine
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- Behavioral side effects
- Time Frame: 3 weeks
- Behavioral side effects are measured by SCL-90-R questionnaire
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Nasim Tabrizi
- Collaborator
- Mazandaran University of Medical Sciences
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Nasim Tabrizi, Associate professor of neurology – Mazandaran University of Medical Sciences
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