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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05357066
Eligibility Criteria:
Inclusion Criteria:
* 2016 American College of Rheumatology Revised criteria for fibromyalgia (2016-ACR)
* Subjects 18 -75 years of age.
* Self-reported pain of at least 4 on the Numeric Pain Rating Scale (NPRS) at screening and baseline.
* Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 4 weeks prior to dosing. Stable means no change in dose or any pain medication.
* Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
* If currently on psychotherapy, it must have been maintained at the same frequency for 4 weeks prior to treatment.
Exclusion Criteria:
* Unstable doses of allowed antidepressants or muscle relaxants or dosages for any other medical condition.
* Pain due to concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, or other chronic widespread pain condition(s) that may confound fibromyalgia pain.
* Psychiatric or cognitive disorder (e.g., current schizophrenia, severe depression, suicidal ideation, dementia, etc.) that the investigator or sponsor considers significant for this study.
* Clinically significant alcohol or other substance abuse within the last 2 years, in the opinion of the investigator.
* Current or recent history of medically inappropriate or illegal use of drugs of abuse including benzodiazepines, opiates, cocaine, cannabinoids, and amphetamines.
* Current treatment with N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, amantadine, dextromethorphan, memantine, methadone, or dextropropoxyphene.
* Subjects who are pregnant, breast feeding, or planning to become pregnant during the course of the study and for 28 days after the final administration of investigational product.
* Any other serious medical condition affecting heart, lung or any other organ system.
* Any impairment, activity or situation that in the judgment of the investigator would prevent satisfactory completion of the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05357066
Study Brief:
Protocol Section:
NCT05357066