๐ŸŒ EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia

RecruitingNAAges 18 Years - anyAllBeijing Tiantan Hospital
NCT07196657 on ClinicalTrials.gov โ†—
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. crisugabalin, a new highly selective ฮฑ2ฮด ligand, has shown potential in animal models or preliminary clinical trials, but there is insufficient evidence for its application in FM. This study aims to explore the effectiveness and safety of pregabalin or crisugabalin in treating FM, with the aim of providing a better treatment option for FM patients.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria; * Aged over 18 years old; * Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM; * Baseline numeric rating scale (NRS) score of 4 or higher; * Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range; * Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 mยฒ; * Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements; Exclusion Criteria: * Previous allergic reactions to pregabalin, crisugabalin, or any of their excipients; * Prior diagnosis of epilepsy or depression requiring antidepressant therapy; * Women who are pregnant or breastfeeding; * Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment; * Suffering from acute or chronic pain disorders other than FM.
๐Ÿ’Š

What it tests

  • Pregabalin
  • Crisugabalin
๐Ÿ“

Where

1 site
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy