Valproic Acid Use in Patients With Neurological Disorders

July 8, 2023 updated by: Rehab Werida, Damanhour University

Valproic Acid Use Evaluation in Patients With Neurological Disorders: a Retrospective and Prospective Analysis

Sodium valproate is a well-known anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of mood stabilizers. Aim of the present study is to assess sodium valproate usage among patients with neurological disorders.

Prescriptions of 600 patients from out-patient pharmacy of neurology department at Mansoura university teaching hospital were analyzed in a retrospective prospective observational study which conducted between January 2015 and December 2017. Data collected include: demographic data, medical history, drug-drug interaction, polypharmacy, medication error, doses and therapeutic duplication. A designed and structured form was used to collect the required information.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective prospective observational study was conducted at the outpatient's pharmacy of Neurology department at tertiary care hospital. After identifying problems with use and completing a follow-up, 3 months of educational intervention (Lectures) among professionals was given. As this study is observational informed consent from all subjects was waived. The subjects were enrolled on the basis of inclusion and exclusion criteria. Patients receiving at least 7 days of Valproic acid, between 10-70 years old, both sexes, were included in the study figure 1. 600 Prescriptions were reviewed between January of 2015 to December of 2017 for patients who were suffering from any psychotic illness and were on psychiatric medications. Then pharmacist educational intervention started and followed up for three months then prescriptions re-evaluted.

Inclusion/ exclusion criteria: The study population was limited to those who were continuously eligible for the outpatient pharmacy refilling thier medications during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period. A designed and structured form was used to collect the required information. Data then collected on Microsoft Excel sheet, which included patients' initial therapeutic indications, concomitant use of oral medications, significant adverse drug effects and any drug -drug interaction.

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Prescriptions of 600 patients from out-patient clinic of neurology department at Mansoura university teaching hospital were analyzed in a retrospective cohort study which conducted between January 2015 and December 2017. Data collected include: demographic data, medical history, drug-drug interaction, polypharmacy, medication error, doses and therapeutic duplication. A designed and structured form was used to collect the required information.

Description

Inclusion Criteria:

  • The study population was limited to those who prescribed with valproate and were continuously eligible for the outpatient during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period.

Exclusion Criteria:

  • Patients who not use valproate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1
n=600
Other: Educational intervention
3 months of educational intervention (Lectures, information bulletin, handbook and hardcopy presentation slides) among professionals and patients.
Other Names:
  • Educational &counselling sessions
Phase 2
n=504
Other: Educational intervention
3 months of educational intervention (Lectures, information bulletin, handbook and hardcopy presentation slides) among professionals and patients.
Other Names:
  • Educational &counselling sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Valproate dose (Number)
Time Frame: 3 month
Right dose
3 month
Number of drugs (Number)
Time Frame: 3 Months
Number of drugs included in the prescriptions analyzed
3 Months
Medication errors (Number)
Time Frame: 3 Months
Medication errors regarding frequency or dose of Sodium valproate
3 Months
Adherence (Number)
Time Frame: 3 Months
Adherence to medication regimens
3 Months
Tolerability (Number)
Time Frame: 3 Months
tolerability was assessed through monitoring of ADRs and recorded in the patient's file.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Mansoura University

Investigators

  • Principal Investigator: Rehab H Werida, Ass. Prof., Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 8, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • valproic acid therapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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