The Efficacy and Safety of Pregabalin and Mirogabalin 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. Mirogabalin, 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 mirogabalin in treating FM, with the aim of providing a better treatment option for FM patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;[1]
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, mirogabalin, 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
Mirogabalin
DrugFor the mirogabalin group, therapy will begin at 5mg twice daily. If the pain will remain inadequately controlled after one week without significant adverse effects, the dose will be escalated in 5 mg per day increments at weekly intervals, with a maximum allowable dose of 15mg twice daily.
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.
Treatment groups
674 Participants
are divided into 2 treatment groupsGroup A: Pregabalin groupActive comparator 1 intervention
Group B: Mirogabalin 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
The average weekly consumption of rescue analgesics
Acetaminophen is permitted as rescue medication for intolerable FM-related pain. The maximum allowable dose is 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use will be recorded prospectively in patient diaries, including date, dose, and frequency of administration.
Time frame
At the weeks 4, 8, and 124
The Revised FM Impact Questionnaire
The Revised FM Impact Questionnaire is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. The total score ranges from 0 to 100, with higher values indicating worse health status.
Time frame
At the weeks 4, 8, and 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Chongqing Three Gorges Central Hospital
Collaborator
Affiliated Hospital of Yanbian University
Collaborator
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Source ClinicalTrials.gov