FibromyalgiaNCT06916403
Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
An observational study of Fibromyalgia, run by Wilderman Medical Clinic at 1 site in Canada.
Trial summary
Previous studies of intravenous ketamine, which is a non-competitive N-methyl-D aspartate receptor antagonist, for fibromyalgia pain relief are limited to three studies. Two studies have focused on short-term pain relief of intravenous ketamine by measuring the patients' pain levels immediately before and after the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Intravenous Ketamine Infusions
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2020to 30 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Two-part Study to Access the Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
Previous studies of intravenous ketamine, which is a non-competitive N-methyl-D aspartate receptor antagonist, for fibromyalgia pain relief are limited to three studies. Two studies have focused on short-term pain relief of intravenous ketamine by measuring the patients' pain levels immediately before and after the infusion. Currently, existing studies used short-term infusions (30-40 minutes) of sub-anesthetic doses of ketamine for pain relief in fibromyalgia patients, whereas the 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 recommend infusing IV ketamine for at least two hours and a minimal total dose of 80 mg.
The rationale of this study is to expand on the existing data of safety and efficacy of intravenous ketamine to relieve fibromyalgia pain. Specifically, this investigation will add data to fill the existing gap regarding the short- and long-term pain relief in the treatment of fibromyalgia with intravenous ketamine infusions. The study will also attempt to determine safety and tolerability. In addition, the characteristics of treatment responders versus non-responders will be assessed in an effort to determine whether specific characteristics can be used to predict treatment response in this group of patients.
Read the detailed description
This study consists of two parts. The first part is a single-centre, retrospective chart review to analyze and summarize the investigators' experience with intravenous ketamine infusions in the treatment of patients with fibromyalgia who received at least four infusions for pain management. For the second part, patients who already received at least three intravenous ketamine infusions (for optimal dose determination) will be enrolled in an open single-group prospective study to receive one intravenous ketamine treatment. In this prospective study, the investigators will evaluate infusion effectiveness, safety, and tolerability as well as the influence of patients' demographic and medical characteristics, including depression status and ketamine dissociation symptoms, on the treatment outcome.
This two-part study aims to evaluate whether intravenous ketamine is effective in reducing pain in patients diagnosed with fibromyalgia. To achieve this goal, the study will assess the effect of intravenous ketamine infusions on short- and long-term pain relief. The study will also evaluate the safety and tolerability of ketamine infusions in fibromyalgia patients and factors that may have an impact on the treatment outcome.
- Conditions
- Fibromyalgia
- Being tested
- Intravenous Ketamine Infusions
- Keywords
- Fibromyalgia, Intravenous Ketamine Infusions, Chronic Pain, Neuropathic Pain, Dissociative State, Depression, Pain Relief
- Medical subject headings
- Fibromyalgia, Chronic Pain, Neuralgia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Ketamine InfusionsDrug
Ketamine will be slowly infused with the routine target dose 1.5-2 mg/kg over 3-4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Study Group | A total of approximately 30 patients diagnosed with fibromyalgia will be selected for participation in the study, all of whom will be treated with one IV ketamine infusion for pain relief according to their regular schedule of IV ketamine infusions.
Each patient will be evaluated at baseline (prior to ketamine infusion), 40 minutes post-infusion, and at follow up visits. Receives: Drug: Intravenous Ketamine Infusions | |
| Retrospective Study group | A total of approximately 20 patients will be selected for participation in the study, all of whom were treated with IV ketamine infusions. Information regarding clinically relevant outcomes will be obtained from chart reviews from patients who meet the eligibility criteria.
The patient's response to treatment will be assessed. Receives: Drug: Intravenous Ketamine Infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Measured: Baseline visit: immediately before IV ketamine infusion
Numeric Rating Scale (NRS)
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Measured: Baseline visit: immediately after the IV ketamine infusion
Numeric Rating Scale (NRS)
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Measured: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Integral of pain relief
IPR is a multidimensional measure combining the duration of patients' pain relief (in days) and the percentage of pain relief that they had experienced. IPR seeks to tap into a fuller picture of the patients' pain relief, since it not only measures current pain levels, but patients' experience of pain, both in duration and percentage of relief, over a longer period of time. The scale has no restrictions, beginning at 0 (no treatment effect). Therefore, the higher the IPR value, the more effective the treatment was at reducing pain
Measured: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Secondary outcomes (17)
The Clinician-Administered Dissociative States Scale (CADSS)
The CADSS is a 27-item scale with 19 subject-rated items and 8 items scored by an observer. The subjective component consists of 19 items which are administered by a clinician who begins each question with the phrase "at this time" and then reads the item to the subject. The subject then endorses one of a range of possible responses: 0 = not at all, 1 = slightly, 2 = moderately, 3 = considerably, 4 = extremely. The subject's response on these 0 to 4 scales is recorded and the clinician moves on to the next item. Three non-empirically derived subscales for the CADSS have been proposed: amnesia (two items), depersonalization (five items), and derealization (12 items).
Measured: Baseline visit: immediately before IV ketamine infusion
The Clinician-Administered Dissociative States Scale (CADSS)
The CADSS is a 27-item scale with 19 subject-rated items and 8 items scored by an observer. The subjective component consists of 19 items which are administered by a clinician who begins each question with the phrase "at this time" and then reads the item to the subject. The subject then endorses one of a range of possible responses: 0 = not at all, 1 = slightly, 2 = moderately, 3 = considerably, 4 = extremely. The subject's response on these 0 to 4 scales is recorded and the clinician moves on to the next item. Three non-empirically derived subscales for the CADSS have been proposed: amnesia (two items), depersonalization (five items), and derealization (12 items).
Measured: Baseline visit: 40 minutes after the IV ketamine infusion
Patient Health Questionnaire (PHQ-9)
PHQ-9 is endorsed by the National Institute for Health and Clinical Excellence for use in primary care in measuring baseline depression severity and responsiveness to treatment. The 9 items on the PHQ-9 consist of the 9 criteria on which the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) depressive disorder diagnoses are based. A 4-point scale indicates a degree of severity; items are rated from 0 (not at all) to 3 (nearly every day).
Measured: Baseline visit: before IV ketamine infusion
Patient Health Questionnaire (PHQ-9)
PHQ-9 is endorsed by the National Institute for Health and Clinical Excellence for use in primary care in measuring baseline depression severity and responsiveness to treatment. The 9 items on the PHQ-9 consist of the 9 criteria on which the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) depressive disorder diagnoses are based. A 4-point scale indicates a degree of severity; items are rated from 0 (not at all) to 3 (nearly every day).
Measured: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
The LANSS is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). S-LANSS is a modified version of the LANSS pain scale to make it capable of self-completion.
Measured: Baseline visit: before IV ketamine infusion
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
The LANSS is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). S-LANSS is a modified version of the LANSS pain scale to make it capable of self-completion.
Measured: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Fibromyalgia Impact Questionnaire, Revised (FIQR)
The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia patients. The revised FIQ has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions), (b) 'overall impact' (contains 2 questions), and (c) 'symptoms' (contains 10 questions). The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score.
Measured: Baseline visit: before IV ketamine infusion
Fibromyalgia Impact Questionnaire, Revised (FIQR)
The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia patients. The revised FIQ has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions), (b) 'overall impact' (contains 2 questions), and (c) 'symptoms' (contains 10 questions). The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score.
Measured: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Patients Global Impression of Change (PGIC)
PGIC is a seven-point single-item scale ranging from 'very much worse' to 'very much improved' worse' with 'no change' as the mid-point that evaluates improvement with treatment during a clinical trial.
Measured: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Periprocedural adverse effects
Variations of heart rate (beats per minute)
Measured: Baseline visit: During the infusion
Periprocedural adverse effects
Variations of blood pressure (mmHg)
Measured: Baseline visit: During the infusion
Periprocedural adverse effects
Variations of pulse oxygen saturation (percentage of hemoglobin carrying oxygen)
Measured: Baseline visit: During the infusion
Periprocedural adverse effects
Presence of dizziness, nausea, chest pain, shortness of breast
Measured: Baseline visit: During the infusion
Postprocedural adverse effects
Variations of heart rate (beats per minute)
Measured: Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Variations of blood pressure (mmHg)
Measured: Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Variations of pulse oxygen saturation (percentage of hemoglobin carrying oxygen)
Measured: Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Presence of dizziness, nausea, chest pain, shortness of breast
Measured: Baseline visit: During 60-90 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start30 Nov 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilderman Medical Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Wilderman, MD, Principal investigator, Wilderman Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916403
- Sponsor's protocol ID
- WMC003
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available according to reasonable demands.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Study to Access the Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT06916403
- Acronym / sponsor ID
- WMC003
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Intravenous Ketamine Infusions, Chronic Pain, Neuropathic Pain, Dissociative State, Depression, Pain Relief
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wilderman Medical ClinicUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 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.
Previous studies of intravenous ketamine, which is a non-competitive N-methyl-D aspartate receptor antagonist, for fibromyalgia pain relief are limited to three studies. Two studies have focused on short-term pain relief of intravenous ketamine by measuring the patients' pain levels immediately before and after the infusion. Currently, existing studies used short-term infusions (30-40 minutes) of sub-anesthetic doses of ketamine for pain relief in fibromyalgia patients, whereas the 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 recommend infusing IV ketamine for at least two hours and a minimal total dose of 80 mg.
The rationale of this study is to expand on the existing data of safety and efficacy of intravenous ketamine to relieve fibromyalgia pain. Specifically, this investigation will add data to fill the existing gap regarding the short- and long-term pain relief in the treatment of fibromyalgia with intravenous ketamine infusions. The study will also attempt to determine safety and tolerability. In addition, the characteristics of treatment responders versus non-responders will be assessed in an effort to determine whether specific characteristics can be used to predict treatment response in this group of patients.
Detailed description
This study consists of two parts. The first part is a single-centre, retrospective chart review to analyze and summarize the investigators' experience with intravenous ketamine infusions in the treatment of patients with fibromyalgia who received at least four infusions for pain management. For the second part, patients who already received at least three intravenous ketamine infusions (for optimal dose determination) will be enrolled in an open single-group prospective study to receive one intravenous ketamine treatment. In this prospective study, the investigators will evaluate infusion effectiveness, safety, and tolerability as well as the influence of patients' demographic and medical characteristics, including depression status and ketamine dissociation symptoms, on the treatment outcome.
This two-part study aims to evaluate whether intravenous ketamine is effective in reducing pain in patients diagnosed with fibromyalgia. To achieve this goal, the study will assess the effect of intravenous ketamine infusions on short- and long-term pain relief. The study will also evaluate the safety and tolerability of ketamine infusions in fibromyalgia patients and factors that may have an impact on the treatment outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Study Group | – | Drug: Intravenous Ketamine InfusionsA total of approximately 30 patients diagnosed with fibromyalgia will be selected for participation in the study, all of whom will be treated with one IV ketamine infusion for pain relief according to their regular schedule of IV ketamine infusions. Each patient will be evaluated at baseline (prior to ketamine infusion), 40 minutes post-infusion, and at follow up visits. |
| Retrospective Study group | – | Drug: Intravenous Ketamine InfusionsA total of approximately 20 patients will be selected for participation in the study, all of whom were treated with IV ketamine infusions. Information regarding clinically relevant outcomes will be obtained from chart reviews from patients who meet the eligibility criteria. The patient's response to treatment will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Intravenous Ketamine InfusionsKetamine will be slowly infused with the routine target dose 1.5-2 mg/kg over 3-4 hours. | Drug | Prospective Study Group, Retrospective Study group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Baseline visit: immediately before IV ketamine infusion
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Numeric Rating Scale (NRS)
Time frame: Baseline visit: immediately after the IV ketamine infusion
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Numeric Rating Scale (NRS)
Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Integral of pain relief
Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
IPR is a multidimensional measure combining the duration of patients' pain relief (in days) and the percentage of pain relief that they had experienced. IPR seeks to tap into a fuller picture of the patients' pain relief, since it not only measures current pain levels, but patients' experience of pain, both in duration and percentage of relief, over a longer period of time. The scale has no restrictions, beginning at 0 (no treatment effect). Therefore, the higher the IPR value, the more effective the treatment was at reducing pain
17 secondary outcomes
The Clinician-Administered Dissociative States Scale (CADSS)
Time frame: Baseline visit: immediately before IV ketamine infusion
The Clinician-Administered Dissociative States Scale (CADSS)
Time frame: Baseline visit: 40 minutes after the IV ketamine infusion
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline visit: before IV ketamine infusion
Patient Health Questionnaire (PHQ-9)
Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time frame: Baseline visit: before IV ketamine infusion
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Fibromyalgia Impact Questionnaire, Revised (FIQR)
Time frame: Baseline visit: before IV ketamine infusion
Fibromyalgia Impact Questionnaire, Revised (FIQR)
Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Patients Global Impression of Change (PGIC)
Time frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Periprocedural adverse effects
Time frame: Baseline visit: During the infusion
Periprocedural adverse effects
Time frame: Baseline visit: During the infusion
Periprocedural adverse effects
Time frame: Baseline visit: During the infusion
Periprocedural adverse effects
Time frame: Baseline visit: During the infusion
Postprocedural adverse effects
Time frame: Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Time frame: Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Time frame: Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Time frame: Baseline visit: During 60-90 minutes after the procedure
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 3 Aug 2026.
- Individual participant dataSharing planned: No. IPD will be available according to reasonable demands.
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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.
Igor Wilderman, MD principal investigator
Wilderman Medical Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Wilderman Medical Clinic at 1 site in Canada.
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 15 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. 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 Canada. 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.
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?
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?
Numeric Rating Scale (NRS) (time frame: Baseline visit: immediately before IV ketamine infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.