The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Phase 2

Active, not recruiting

• Conditions: Chronic Migraine, Headache
• Interventions: Drug: Lidocaine IV

• Registration Number: NCT06109389
• Lead Sponsor: Alexandria University

Brief Summary

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

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 Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine infusion	Lidocaine IV	infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks
infusion of saline	Lidocaine IV	infusion saline for 4 successive weeks once weekly over 45 min

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alexandria University,Medical Research Institute; 🇪🇬 Alexandria, Egypt