Pregabalin versus crisugabalin for fibromyalgia pain

Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Crisugabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

This trial will test whether pregabalin or the newer drug crisugabalin reduces moderate-to-severe fibromyalgia pain in adults who have not yet used recommended fibromyalgia medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07196657 on ClinicalTrials.gov

What this trial studies

Adults meeting the 2016 fibromyalgia diagnostic criteria with baseline pain NRS ≥4 and who are refractory to non‑pharmacological care will be enrolled to receive either pregabalin or crisugabalin per protocol. The study will track changes in pain scores and record adverse events, with routine monitoring of liver enzymes and renal function. Participants must meet laboratory cutoffs (AST/ALT <2×ULN, eGFR ≥30 mL/min/1.73 m²) and will be followed at participating hospital sites in Beijing. The goal is to compare pain relief and tolerability between the established drug pregabalin and the newer selective α2δ ligand crisugabalin.

Who should consider this trial

Good fit: Adults aged 18 or older with fibromyalgia per 2016 criteria, moderate-to-severe symptoms (NRS ≥4), refractory to non-pharmacologic therapies, and no prior use of recommended pharmacologic FM treatments, with acceptable liver and kidney function.

Not a fit: People with prior epilepsy, depression requiring antidepressants, pregnancy or breastfeeding, allergy to the study drugs, severe uncontrolled systemic illness, or eGFR below 30 mL/min/1.73 m² are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If crisugabalin is safer or more effective than pregabalin, patients could gain a better-tolerated option that provides greater pain relief for fibromyalgia.

How similar studies have performed: Pregabalin is an established but only partially effective treatment (about 25–40% pain relief rate), while crisugabalin has shown promise in animal studies and early clinical work but lacks robust evidence in fibromyalgia.

Eligibility criteria

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 m²;
* 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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Fang Luo, M.D.

Conditions: Fibromyalgia, Pregabalin, Pain