The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06109389

Enrollment

Registered

2023-10-31

Start date

2023-10-01

Completion date

2024-06-01

Last updated

2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine, Headache

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).

Interventions

DRUGLidocaine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Migraine attack duration	3 Month	Duration of each attack from (4) hours to (72) hours
Calcitonin Gene Related Peptide Biomarker.	3 Month	Measurement of CGRP before and after( 1) month from first infusion treatment
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
Migraine Disability Assessment Questionaire	3 Month	(0) Absent of disability,(270) Extremely severe disability,more than (21) severe disability

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026