Refractory Chronic MigraineEarly Phase 1NCT06935552
Ketamine and Lidocaine Infusion in Refractory Chronic Migraine
A Early Phase 1 study testing Ketamine infusion, Lidocaine Intravenous Infusion and Dextrose 5% in water in people with Refractory Chronic Migraine, run by Assiut University.
Trial summary
Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Refractory Chronic Migraine
- What is being tested?
- Ketamine infusion, Lidocaine Intravenous Infusion and Dextrose 5% in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Who may be able to join
- All participants must fulfill the following inclusion criteria
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ketamine and Lidocaine Infusion for Refractory Chronic Migraine: Comparative Study
Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study
- Conditions
- Refractory Chronic Migraine
- Being tested
- Ketamine infusion, Lidocaine Intravenous Infusion, Dextrose 5% in water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine infusionDrug
group A will receive ketamine intravenous infusion
Lidocaine Intravenous InfusionDrug
group B will receive lidocaine intravenous infusion
Dextrose 5% in waterDrug
group C will only receive Dextrose 5% in water
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | will receive ketamine Receives: Drug: Ketamine infusion |
| Lidocaine | Experimental | will receive lidocaine Receives: Drug: Lidocaine Intravenous Infusion |
| Dextrose | Placebo comparator | Not described Receives: Drug: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractory Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElRahman Mohamed Mohamed Mohamed, Assiut University
- Investigators
- Nageh Fouly Kamel, PhD., Study chair, Assiut UniversityMohamed Ahmed Abdelhameed, PhD., Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935552
- Sponsor's protocol ID
- ketamine vs lidocaine in RCM
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18484982Ray 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.
PubMed 35356451Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.
PubMed 19378524Kohrs 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.
PubMed 9806706Natoli 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.
PubMed 19614702
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Lidocaine Infusion for Refractory Chronic Migraine: Comparative Study
- ClinicalTrials.gov ID
- NCT06935552
- Acronym / sponsor ID
- ketamine vs lidocaine in RCM
- Conditions
- Refractory Chronic Migraine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ketamine and lidocaine infusion for refractory chronic migraine: Comparative Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine infusionwill receive ketamine |
| Lidocaine | Experimental | Drug: Lidocaine Intravenous Infusionwill receive lidocaine |
| Dextrose | Placebo comparator | Drug: Dextrose 5% in water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All participants must fulfill the following inclusion criteria
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine infusiongroup A will receive ketamine intravenous infusion | Drug | Ketamine |
| Lidocaine Intravenous Infusiongroup B will receive lidocaine intravenous infusion | Drug | Lidocaine |
| Dextrose 5% in watergroup C will only receive Dextrose 5% in water | Drug | Dextrose |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Background: PubMed 18484982Schulman 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.
- Background: PubMed 35356451Ray 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.
- Background: PubMed 19378524Lauretti GR. Mechanisms of analgesia of intravenous lidocaine. Rev Bras Anestesiol. 2008 May-Jun;58(3):280-6. doi: 10.1590/s0034-70942008000300011. English, Portuguese.
- Background: PubMed 9806706Kohrs 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.
- Background: PubMed 19614702Natoli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nageh Fouly Kamel, PhD. study chair
Assiut University
Mohamed Ahmed Abdelhameed, PhD. study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine infusion, Lidocaine Intravenous Infusion and Dextrose 5% in water in people with Refractory Chronic Migraine, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AbdElRahman Mohamed Mohamed (+201066586931, hmdmhmmdl1692@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain scale using Numeric rating scale (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06935552, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.