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Migraine Headache With Intractable MigraineEarly Phase 1NCT03896256

Ketamine for Refractory Chronic Migraine: a Pilot Study

A Early Phase 1 study testing ketamine infusion in people with Migraine Headache With Intractable Migraine, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ketamine is a drug used for anesthesia but at low doses it is a very effective pain reliever in several chronic conditions. Preliminary studies have shown that ketamine might be effective for patients with refractory chronic migraine, which is a severe type of headache for which patients usually have tried and failed… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ketamine infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
22 Mar 2019to 1 Jan 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients (age 18 years and older) who meet the criteria of refractory chronic migraine as defined by the International Classification of Headache Disorders-II definition who present to the Jefferson Headache Center after failing an inpatient course of treatment at Methodist.

Who cannot join

  • Schizophrenia
  • active psychosis
  • pregnancy
  • poorly controlled cardiovascular disease
  • cirrhosis
  • previous treatment with intravenous ketamine
  • These criteria are all consistent with the 2018 Consensus Guidelines for Ketamine. Patients who are deemed poor candidates for ketamine by a study team member for any reason, such as intolerance of prior neuroleptic medications, may be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Ketamine is a drug used for anesthesia but at low doses it is a very effective pain reliever in several chronic conditions. Preliminary studies have shown that ketamine might be effective for patients with refractory chronic migraine, which is a severe type of headache for which patients usually have tried and failed many medications and can cause severe disability to their lives. This study will evaluate ketamine prospectively when given to patients who have "failed" an initial inpatient treatment.

Read the detailed description

This study is a comparison between ketamine, used in the standard fashion at Thomas Jefferson University Hospital (TJUH) for 5 days, and past data collected from inpatient treatment at Methodist Hospital. The collection of blood samples is the only experimental part of the study.

Eligible patients will be identified by a study team member at the end of inpatient treatment at Methodist Hospital. The study will be explained to patients at that time. Patients who express interest in participation will be given a consent packet to take home and bring to their office visit at Jefferson Headache Center prior to admission to TJUH for ketamine infusions. Patients will be given the time to read over the study information and have all questions answered to their satisfaction. The will provide informed consent at the end of the office visit if they choose to participate. Baseline demographic information and past medical history including current medications and medications previously tried will be collected. Patients and assessors will not be blinded to treatment.

When the patient is admitted to the hospital for treatment, the neurology team will be the admitting team and will consult the Acute Pain Service (APS) for assistance with management of ketamine, which is standard practice when ketamine is used for headache treatment at TJUH. Patients will be admitted for a total of 5 full days from the time of admission until discharge. Adjustments to ketamine infusion will be made according to standard APS protocol and data will be collected by the research coordinator or other study team personnel. A standard 11-point numeric rating scale (NRS) will be used to obtain pain ratings and they will be collected twice daily. A 4-point pain assessment scale (0=none, 1=mild, 2=moderate, 3=severe) will also be used. Blood samples will be collected at baseline and at 24 hours, 72 hours, and the final day of treatment. They will be performed at external laboratories. A daily headache diary will be used for all patients and they will be given instructions how to use one prior to discharge. A depression screening will be performed on day of admission to TJUH.

Follow-up office visits at approximately 2 weeks and 2 months will be used for collection of pain ratings and medication use. Headache diaries will be collected. If telephone visits occur, assessments will be done over the phone in place of an office visit.

Being tested
ketamine infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ketamine infusionDrug

    Also called Ketalar

    Ketamine will be used in subanesthetic doses for patients with refractory chronic migraine to see if it improves pain after a 5-day continuous infusion.

Study groups in NCT03896256
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients will be admitted to the hospital for a total of 5 full days from the time of admission until discharge. Ketamine infusion will be started on day 1. Adjustments to ketamine infusion will be made according to standard acute pain service protocol.
Receives: Drug: ketamine infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The improvement in pain after ketamine (0 to 10 numerical rating scale) will be compared to improvement after initial inpatient treatment.

    Each patient will serve as his or her own control.

    Measured: 1 year

  2. Improvement in a 0-3 qualitative scale where 0=none, 1=mild, 2=moderate, 3=severe pain will be used comparing change from beginning to end of ketamine treatment to change after initial inpatient treatment.

    Each patient will serve as his or her own control.

    Measured: 1 year

Secondary outcomes (2)

  1. Incidence of adverse effects

    The number and severity of adverse effects, including hallucinations, nightmares, nausea/vomiting, blurry vision, sedation, and changes in liver function tests, will be recorded.

    Measured: 1 year

  2. Ketamine metabolite levels

    Levels of ketamine metabolites, including norketamine, hydroxynorketamines, hydroxyketamines, and dehydronorketamines, will be measured at baseline, 24 h, 48 h, 72 h, and just before infusion is stopped.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start22 Mar 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03896256
Sponsor's protocol ID
19D0.99
Status last verified
Mar 2020
First submitted
26 Mar 2019
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Schwenk ES, Dayan AC, Rangavajjula A, Torjman MC, Hernandez MG, Lauritsen CG, Silberstein SD, Young W, Viscusi ER. Ketamine for Refractory Headache: A Retrospective Analysis. Reg Anesth Pain Med. 2018 Nov;43(8):875-879. doi: 10.1097/AAP.0000000000000827.

    PubMed 29923953

  • Cohen SP, Bhatia A, Buvanendran A, Schwenk ES, Wasan AD, Hurley RW, Viscusi ER, Narouze S, Davis FN, Ritchie EC, Lubenow TR, Hooten WM. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):521-546. doi: 10.1097/AAP.0000000000000808.

    PubMed 29870458

  • Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.

    PubMed 29870457

  • Schulman E. Refractory migraine - a review. Headache. 2013 Apr;53(4):599-613. doi: 10.1111/head.12047. Epub 2013 Feb 13.

    PubMed 23405959

  • Afridi SK, Giffin NJ, Kaube H, Goadsby PJ. A randomized controlled trial of intranasal ketamine in migraine with prolonged aura. Neurology. 2013 Feb 12;80(7):642-7. doi: 10.1212/WNL.0b013e3182824e66. Epub 2013 Jan 30.

    PubMed 23365053

  • Pomeroy JL, Marmura MJ, Nahas SJ, Viscusi ER. Ketamine Infusions for Treatment Refractory Headache. Headache. 2017 Feb;57(2):276-282. doi: 10.1111/head.13013. Epub 2016 Dec 27.

    PubMed 28025837

  • Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.

    PubMed 39428602

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing ketamine infusion in people with Migraine Headache With Intractable Migraine, run by Thomas Jefferson University at 1 site in United States.

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 1 inclusion and 7 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: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The improvement in pain after ketamine (0 to 10 numerical rating scale) will be compared to improvement after initial inpatient treatment. (time frame: 1 year). 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 NCT03896256, which also lists 7 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 11 Mar 2020.

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