The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregabalin, Pregabalin with dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Fibromyalgia, Pregabalin, Dexmedetomidine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Dexmedetomidine in the Treatment of Fibromyalgia: A Multicenter Clinical Study
Overview
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. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
Interventions
- Drug Pregabalin
In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily. - Drug Pregabalin with dexmedetomidine
In the pregabalin with dexmedetodimine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. The dose of dexmedetomidine administered via nasal spray is 4 sprays per day, with 1 spray in each nostril on both sides. The spray should be held for about 30 seconds before another 1 spray is administered in each nostril. A total of 4 sprays are given. The total dosage is 100 μg.
Primary outcome measures
- The average pain intensity [Time frame: At the 4-weeks]
Secondary outcome measures (8)
- The worst pain intensity [Time frame: At the weeks 1, 2, 4, and 8]
- The proportion of patients achieving pain reduction [Time frame: At the weeks 1, 2, 4, and 8]
- The Revised FM Impact Questionnaire [Time frame: At the weeks 1, 2, 4, and 8]
- The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales [Time frame: At the weeks 1, 2, 4, and 8]
- The short-form 36 Health Survey (SF-36) [Time frame: At the weeks 1, 2, 4, and 8]
- The Medical Outcomes Study Sleep Scale (MOS) [Time frame: At the weeks 1, 2, 4, and 8]
- The Beck Depression Inventory-Ⅱ (BD-Ⅱ) [Time frame: At the weeks 1, 2, 4, and 8]
- Adverse Events [Time frame: Through study completion, an average of 8 weeks]
Eligibility criteria
Inclusion criteria
- Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
- Aged 18 years or older;
- Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
- Numeric rating scale (NRS) score ≥ 4 at baseline;
- Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
Exclusion criteria
- History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;
- History of epilepsy, or depression requiring antidepressant medications;
- Pregnancy or breastfeeding;
- Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
- With acute or chronic pain conditions other than FM.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing
Identifiers
NCT: NCT07230197 · KY2025-217-03-07