The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine 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. 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.
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 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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Pregabalin
DrugIn 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.
Pregabalin with dexmedetomidine
DrugIn 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Monotherapy groupActive comparator 1 intervention
Group B: Combination therapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The average pain intensity
The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
At the 4-weeksSecondary outcomes
1
The worst pain intensity
The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. 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, and 82
The proportion of patients achieving pain reduction
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline 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, and 83
The Revised FM Impact Questionnaire
The Revised FM Impact Questionnaire assesses the severity of FM symptoms and their impact on daily functioning. It evaluates three linked domains: function, overall impact, and symptoms, using a 0 to10 NRS. The total score ranges from 0 to 100, with higher scores indicating greater disease burden.
Time frame
At the weeks 1, 2, 4, and 84
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales
BPI-S accesses pain intensity over the past 24 hours, calculated as the average of items 3 to 6 on the BPI, scored using a 0 to 10 NRS. In the NRS scale, 0 indicates no pain, while 10 represents the worst pain imaginable. The total score ranges from 0 to 40, with higher scores indicating greater pain severity. BPI-I evaluates the degree to which pain interferes with daily activities, including general activity, mood, mobility work, relationships, sleep, and pleasure. This subscale comprises 7 items, each scored from 0 (no interference) to 10 (complete interference), with a total score ranging from 0 to 70.
Time frame
At the weeks 1, 2, 4, and 8Sponsors and contacts
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Source ClinicalTrials.gov