Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

April 11, 2025 updated by: AbdElRahman Mohamed Mohamed Mohamed, Assiut University

Ketamine and Lidocaine Infusion for Refractory Chronic Migraine: Comparative Study

Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

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

N/A

Description

Inclusion Criteria:

  • All participants must fulfill the following inclusion criteria

    1. medically stable outpatients with confirmed diagnosis of refractory chronic migraine according to American Headache society
    2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
    3. Men or women older than 18years of age.
    4. clear written informed consent from each participant in the trial.
    5. Adult patients with refractory migraine or refractory chronic migraine defined according to the American headache society

Exclusion Criteria:

  1. Pregnancy, active psychosis, liver disease, uncontrolled cardiac disease or cardiac rhythm abnormalities
  2. presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
  3. participation in any other type of medical research that may interfere with the interpretation of the study.
  4. patients with hemocoagulation disorders, local infection or those who refused to consent

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Dextrose
Drug: Dextrose 5% in water
group C will only receive Dextrose 5% in water
Experimental: Ketamine
will receive ketamine
Drug: Ketamine infusion
group A will receive ketamine intravenous infusion
Experimental: Lidocaine
will receive lidocaine
Drug: Lidocaine Intravenous Infusion
group B will receive lidocaine intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain scale using Numeric rating scale
Time Frame: From enrollment to the end of treatment at 6 weeks
Pain assessment by using a Numeric rating scale (0 (no pain) to 10 (worst possible pain). Scores of 1-3 are considered mild, 4-6 moderate, and 7-10 severe) before the infusion and daily for 1-week post infusion, then weekly for 6 weeks post infusion
From enrollment to the end of treatment at 6 weeks
Changes in pain scale using Migraine disability assessment
Time Frame: From enrollment to the end of treatment at 6 weeks
Migraine disability assessment test before the infusion and daily for 1-week post infusion, then weekly for 6 weeks post infusion
From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Nageh Fouly Kamel, PhD., Assiut University
  • Study Chair: Mohamed Ahmed Abdelhameed, PhD., Assiut 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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ketamine vs lidocaine in RCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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