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CompletedEarly Phase 1

Ketamine for Refractory Chronic Migraine: a Pilot Study

NCT03896256 · Thomas Jefferson University

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
6
Target enrolment
1
Study sites
1 US states

What it is testing

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 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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over 1 year

  • 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.

    Measured over 1 year

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Where

1 study site

FacilityCityRegionCountry
Thomas Jefferson University HospitalPhiladelphiaPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03896256 on ClinicalTrials.gov →

Last updated in the registry 2020-03-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in