The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

October 25, 2023 updated by: Alexandria University

The Efficacy of Intravenous Lidocaine Infusion in Chronic Unilateral Migraine Headache Clinical and Laboratory Assessment .Aprospective Randomized Double Blind Controlled Study

STUDY THE EFFICACY OF INTRAVENOUS LIDOCAINE INFUSION ON PATIENTS WITH CHRONICUNILATERAL MIGRAINE HEADACHE ..NO OF PATIENTS 80..WILLBE DIVIDED INTO 2 GROUPS..FIRST WILL RECEIVE MEDICAL TREATMENT PLUS LIDOCAINE INFUSION ONCE WEEKLY FOR 4 SUCCESIVE WEEKS ,OTHER WILL RECEIVE MEDICAL TREATMENT PLUS SALINE INFUSION SAME REGIMNE,FOLLOW UP USING MONTHLY MIGRAINE DAYS,VAS SCORE,MIDAS SCORE,QUALITY OF LIFE QUESTIONAIRE,PRE AND POST MEASUREMENT OF CALCITONIN GENE RELATED PEPTIDE

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Group A will receive medical treatment for migraine plus normal saline infusion,Group B will receive medical treatment plus lidocaine infusion at dose from 3 to 4 mg per kg,computer generated random number will be used to identify the selected blocks and give the sequence of patients allocation,guarantee equal random in each group a set of permuted blocks will be generated. Each block has 4 differently ordered treatment assignments.Block 1 (AABB),Block2(ABAB),Block3(BABA),Block 4(ABBA),Block5(BAAB),Block 6(BBAA).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 5310002
        • Alexandria University,Medical Research Institute

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age (18-55) years for both genders.
  • Patients with chronic unilateral migraine headache for at least (3) month with VASscore more than (4).
  • Patient who failed to respond to conservative treatment as medical treatment algorithm including at least tow preventive trials.

Excusion criteria:

  • patient with disabling chronic disease or psychiatric illness
  • unstable cardiac arrhythmia
  • patient refusal red flags

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infusion of saline
infusion saline for 4 successive weeks once weekly over 45 min
Drug: Lidocaine IV
LIDOCAINE INFUSION STARTED 3 MG PER KG FOR 2 SUCCESSIVE WEEKS ,THEN 4 MG PER KG FOR ANOTHER 2 WEEKS .ONCE WEEKLY,other group saline infusion once weekly for 4 successive weeks
Other Names:
  • Saline infusion once weekly for 4 successive weeks
Active Comparator: lidocaine infusion
infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks
Drug: Lidocaine IV
LIDOCAINE INFUSION STARTED 3 MG PER KG FOR 2 SUCCESSIVE WEEKS ,THEN 4 MG PER KG FOR ANOTHER 2 WEEKS .ONCE WEEKLY,other group saline infusion once weekly for 4 successive weeks
Other Names:
  • Saline infusion once weekly for 4 successive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly Migraine Days
Time Frame: 3 Month
Number of Migraine Attacks Per Month More or less than (15) for chronicity
3 Month
Verbal analogue scale for pain
Time Frame: 3 month
verbal analogue scale for pain from( 0) to( 10) as( 0) no pain( 10) severe pain untolerable
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine attack duration
Time Frame: 3 Month
Duration of each attack from (4) hours to (72) hours
3 Month
Calcitonin Gene Related Peptide Biomarker.
Time Frame: 3 Month
Measurement of CGRP before and after( 1) month from first infusion treatment
3 Month
Migraine Specific Quality Of Life Questionaire
Time Frame: 3 Month
14 questions ,each one measured from ( 1) never affect to(6) always affect ,answers summed for all questions value is obtained
3 Month
Migraine Disability Assessment Questionaire
Time Frame: 3 Month
(0) Absent of disability,(270) Extremely severe disability,more than (21) severe disability
3 Month

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Study Director: Sahar ah El karadawy, phd, Medical Research I nstitute

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)

October 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E/C.S/N.T71/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data and results will be available to share of other researches after completion

IPD Sharing Time Frame

6 to 9 month

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

Clinical Trials on Chronic Migraine, Headache

Clinical Trials on Lidocaine IV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe