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Could a One-Time ketamine infusion tame cluster headaches?

NCT ID NCT04814381

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a single 2-hour infusion of ketamine combined with magnesium sulfate can reduce the number of daily attacks in people with refractory chronic cluster headache—a rare and severe headache disorder. 93 adults who had at least 2 attacks per day and did not respond to standard treatments received either the drug combination or an active placebo (hydroxyzine). The main goal was to compare weekly attack counts before treatment and one week after.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketamine and magnesium sulfate combination
What this could lead to
If it works, this could offer a new, quick-acting option to reduce daily attacks for people with hard-to-treat chronic cluster headache.
What could go wrong
This is a single infusion with only short-term follow-up (90 days). The earlier promising results were from a small, uncontrolled study, so the placebo-controlled trial may not confirm the same benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

93 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>= 18 years * Chronic cluster headache diagnosis made according to ICHD-3 criteria * A mean of at least 2 attacks/day during the 14 days before infusion * Insufficient efficacy or intolerance or contra-indication to the use of the 3 main validated treatments (verapamil, lithium and sub-occipital steroids injections) * Stable preventive treatment for at least 7 days before infusion Exclusion Criteria: * Pregnant or lactating woman * Contra-indication to ketamine use (uncontrolled high blood pressure, stoke history, severe cardiac failure) * Ketamine use during the previous year * Hypersensitivity to the product or their metabolites * Severe renal insufficiency (creatinine clearance \< 30ml/min)

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Conditions

The condition(s) this trial relates to.

cluster headache syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory chronic cluster headache

Contacts and locations

Locations

  • AP-HM Marseille

    Marseille, 13005, France

  • CH Annecy Genevois

    Annecy, 74370, France

  • CHRU De Lille

    Lille, 59000, France

  • CHU Grenoble-Alpes

    Voiron, 38500, France

  • CHU Nantes, Hopital Nord Laennec

    Nantes, 44000, France

  • CHU Rouen

    Rouen, 76100, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000, France

  • CHU de Montpellier

    Montpellier, 34295, France

  • Clinique Beau Soleil

    Montpellier, 34070, France

  • Hopital Pierre Paul Riquet

    Toulouse, 31059, France

  • Hopital de Hautepierre

    Strasbourg, 67098, France

  • Hospices civils de Lyon, Hôpital Pierre Wertheimer

    Lyon, 69500, France

  • Hôpital Lariboisière

    Paris, 75010, France

  • Polyclinique Jean Villar

    Bruges, 33520, France

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