The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

NCT06109389 | Unknown Phase 2

• 1 other identifier: E/C.S/N.T71/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (2)

• Monthly Migraine Days

  Number of Migraine Attacks Per Month More or less than (15) for chronicity

  3 Month

• Verbal analogue scale for pain

  verbal analogue scale for pain from( 0) to( 10) as( 0) no pain( 10) severe pain untolerable

  3 month

Secondary Outcomes (4)

• Migraine attack duration

  3 Month

• Calcitonin Gene Related Peptide Biomarker.

  3 Month

• Migraine Specific Quality Of Life Questionaire

  3 Month

• Migraine Disability Assessment Questionaire

  3 Month

Study Arms (2)

infusion of saline

EXPERIMENTAL

infusion saline for 4 successive weeks once weekly over 45 min

Drug: Lidocaine IV

lidocaine infusion

ACTIVE COMPARATOR

infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks

Drug: Lidocaine IV

Interventions

Lidocaine IV DRUG

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

Also known as: Saline infusion once weekly for 4 successive weeks

infusion of saline; lidocaine infusion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University,Medical Research Institute

Alexandria, 5310002, Egypt

Location

Related Publications (13)

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• Al Ghadeer HA, AlSalman SA, Albaqshi FM, Alsuliman SR, Alsowailem FA, Albusror HA, AlAbdi ZI, Alwabari EM, Alturaifi ZA, AlHajji AM. Quality of Life and Disability Among Migraine Patients: A Single-Center Study in AlAhsa, Saudi Arabia. Cureus. 2021 Nov 2;13(11):e19210. doi: 10.7759/cureus.19210. eCollection 2021 Nov.

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  PMID: 34145431 RESULT

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  PMID: 30674285 RESULT

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  PMID: 10772585 RESULT

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  PMID: 22083262 RESULT

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  PMID: 11554951 RESULT

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  PMID: 35295486 RESULT

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  PMID: 34956071 RESULT

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  PMID: 15957691 RESULT

• Schwenk ES, Walter A, Torjman MC, Mukhtar S, Patel HT, Nardone B, Sun G, Thota B, Lauritsen CG, Silberstein SD. Lidocaine infusions for refractory chronic migraine: a retrospective analysis. Reg Anesth Pain Med. 2022 Jul;47(7):408-413. doi: 10.1136/rapm-2021-103180.

  PMID: 35609890 RESULT

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  PMID: 16389388 RESULT

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sahar ah El karadawy, phd

  Medical Research I nstitute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 31, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 to 9 month

Locations

EG (1)