Ketamine and Lidocaine Infusion in Refractory Chronic Migraine

NCT06935552 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ketamine vs lidocaine in RCM
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study

Conditions

Refractory Chronic Migraine

Outcome Measures

Primary Outcomes (2)

• Changes in pain scale using Numeric rating scale

  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

  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

Study Arms (3)

Ketamine

EXPERIMENTAL

will receive ketamine

Drug: Ketamine infusion

Lidocaine

EXPERIMENTAL

will receive lidocaine

Drug: Lidocaine Intravenous Infusion

Dextrose

PLACEBO COMPARATOR

Drug: Dextrose 5% in water

Interventions

Ketamine infusion DRUG

group A will receive ketamine intravenous infusion

Ketamine

Lidocaine Intravenous Infusion DRUG

group B will receive lidocaine intravenous infusion

Lidocaine

Dextrose 5% in water DRUG

group C will only receive Dextrose 5% in water

Dextrose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Schulman EA, Lake AE 3rd, Goadsby PJ, Peterlin BL, Siegel SE, Markley HG, Lipton RB. Defining refractory migraine and refractory chronic migraine: proposed criteria from the Refractory Headache Special Interest Section of the American Headache Society. Headache. 2008 Jun;48(6):778-82. doi: 10.1111/j.1526-4610.2008.01132.x. Epub 2008 May 14.

  PMID: 18484982 BACKGROUND

• Ray JC, Cheng S, Tsan K, Hussain H, Stark RJ, Matharu MS, Hutton E. Intravenous Lidocaine and Ketamine Infusions for Headache Disorders: A Retrospective Cohort Study. Front Neurol. 2022 Mar 9;13:842082. doi: 10.3389/fneur.2022.842082. eCollection 2022.

  PMID: 35356451 BACKGROUND

• Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.

  PMID: 19378524 BACKGROUND

• Kohrs R, Durieux ME. Ketamine: teaching an old drug new tricks. Anesth Analg. 1998 Nov;87(5):1186-93. doi: 10.1097/00000539-199811000-00039. No abstract available.

  PMID: 9806706 BACKGROUND

• Natoli JL, Manack A, Dean B, Butler Q, Turkel CC, Stovner L, Lipton RB. Global prevalence of chronic migraine: a systematic review. Cephalalgia. 2010 May;30(5):599-609. doi: 10.1111/j.1468-2982.2009.01941.x.

  PMID: 19614702 BACKGROUND

MeSH Terms

Interventions

Glucose; Water

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Nageh Fouly Kamel, PhD.

  Assiut University

  STUDY CHAIR

• Mohamed Ahmed Abdelhameed, PhD.

  Assiut University

  STUDY CHAIR

Central Study Contacts

AbdElRahman Mohamed Mohamed

CONTACT

+201066586931; hmdmhmmdl1692@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor in neurology and psychiatry department

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04