NCT07230197

The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Dexmedetomidine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibromyalgia
• Pregabalin
• Dexmedetomidine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-06-30
• Completion: 2027-08-31
• First posted: 2025-11-17
• Last updated: 2025-11-28

Locations

1 site across 1 country: China