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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Pregabalin
DrugFor the pregabalin group, treatment will be initiated at a dosage of 150 mg daily, administered into 2 or 3 divided doses. After 3 to 7 days, the dose will be titrated to 300 mg per day, with subsequent incremental increases of 150 mg daily permitted at 3-day to 7-day intervals based on therapeutic response and tolerability, up to a maximum dose of 450 mg daily.
Crisugabalin
DrugFor the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily.
Treatment groups
1,116 Participants
are divided into 2 treatment groupsGroup A: Pregabalin groupActive comparator 1 intervention
Group B: Crisugabalin groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients achieving pain relief
The proportion of patients achieving pain relief defined as the proportion of patients whose baseline average pain intensity is reduced by at least 50%. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
At the 12-weeksSecondary outcomes
1
The average pain intensity
The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
At the weeks 1, 2, 4, 8, and 122
The worst pain intensity
The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
At the weeks 1, 2, 4, 8, and 123
Dose of crisugabalin or pregabalin
the dose of experimental drug
Time frame
At the week 1, 2, 4, 8, 124
Average weekly consumption of rescue analgesics
Acetaminophen will be permitted as rescue medication for FM-related pain, at doses up to 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use, including dose and frequency, will be recorded prospectively.
Time frame
at weeks 4, 8, 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov