Effect of Pyridoxine on Behavioral Adverse Events of Leve... | NCT05008354

Studies
Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam

NCT05008354

Sponsor

Nasim Tabrizi

Status

Completed

Last Update Posted

Mar 29, 2022Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Epilepsy
Pyridoxine
Behavior Problem

Interventions

Pyridoxine
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Sep 1, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Aug 10, 2021

First Submission Date that Met QC Criteria

Aug 10, 2021

First Posted Date

Aug 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Mar 29, 2022Actual

Name	Class
Mazandaran University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pyridoxine	Active Comparator		Drug: Pyridoxine
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pyridoxine	Drug	Pyridoxine tablet 40mg once daily	Pyridoxine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behavioral side effects	Behavioral side effects are measured by SCL-90-R questionnaire	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bu Ali Sina Hospital		Sari	Mazandaran	4815837477	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D001523	Mental Disorders

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011736	Pyridoxine

Ancestor Terms

ID	Term
D025101	Vitamin B 6
D010847	Picolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided