Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT06916403
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06916403
Study Brief:
Protocol Section:
NCT06916403