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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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 α2δ 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Pregabalin
  • Crisugabalin

Treatment groups

1,116 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Tiantan Hospital

Lead sponsor

China-Japan Friendship Hospital

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Peking University Third Hospital

Collaborator

The Fourth Affiliated Hospital of Harbin Medical University

Collaborator

Zhongnan Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

The Affiliated Hospital of Yanbian University

Collaborator

The Second Hospital University of South China

Collaborator

LanZhou University

Collaborator