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Can a single ketamine infusion rewrite the story of fibromyalgia pain?

NCT ID NCT06916403

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether slow intravenous ketamine infusions can safely reduce pain in people with fibromyalgia. Researchers will measure pain levels before and after treatment, and track how long any relief lasts. They will also look for traits that predict who responds best, aiming to personalize future treatment.

What this could mean

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

Active substance
ketamine given as an intravenous infusion
What this could lead to
If effective, ketamine infusions could offer a new option for managing fibromyalgia pain, potentially providing longer-lasting relief than current treatments.
What could go wrong
This is a small, early-stage trial. Ketamine can cause dissociative side effects, and pain relief may be short-lived or not work for everyone.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Who is studied

Patients will be recruited from Wilderman Medical Clinic, a chronic pain clinic located in Thornhill, Ontario. The clinic consists of state-of-the-art out-patient facilities, an interdisciplinary team and nursing support.

Ages

18 years and older

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: To be included in Part 1 of the study, patients must fulfil the following criteria: * Given written consent to permit Wilderman Medical Clinic investigators to use their medical and demographic information in research studies. * Male or female \>18 years of age * Having been diagnosed with fibromyalgia * Received at least 4 IV ketamine infusion(s) * Made at least one rating of pain (NRS) immediately before the intervention and one after the intervention * Had follow-up data recorded on the follow-up visit: percentage and duration of pain relief To be included in Part 2 of the study, patients must fulfil the following criteria: * Male or female \>18 years of age * Given the written Informed Consent Form to participate in the study * Having been diagnosed with fibromyalgia * Having been prescribed IV ketamine infusions treatment * Passed safety screening for ketamine infusions * Had at least 3 IV ketamine infusions for dose optimization * Willingness and ability to comply with the study procedure and the ability to follow verbal and written instructions Exclusion Criteria: Patients will be excluded from Part 1 of the study if they meet any of the following criteria: * Age less than 18 years old * Absence of signed Informed Consent Form * Patients who received less than 4 IV ketamine infusion(s) * Insufficient information to conduct analysis (e.g. absence of pain ratings or follow up measurements) Patients will be excluded from the Part II of the study if they meet any of the following criteria: * Age less than 18 years old * Absence of signed Informed Consent Form * Received less than 3 IV ketamine infusions * Have any contradictions to the administration of intravenous ketamine (known allergy to ketamine or fail to pass Ketamine treatment screening) * Diagnosis of dementia or other cognitive impairments * Any clinically significant acute or chronic medical condition that in the judgment of Investigator may preclude the use of intravenous ketamine or compromise patient safety, limit patient's ability to complete the study, and/or compromise the objectives of the study. * Participation in any other clinical study within 3 months prior to screening and during the study period.

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Conditions

The condition(s) this trial relates to.

Chronic Pain Depression fibromyalgia neuralgia

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wilderman Medical Clinic

    Thornhill, Ontario, L4J 1W3, Canada

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