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

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07230197
Status
Recruiting
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Conditions

  • Dexmedetomidine
  • Fibromyalgia
  • Pregabalin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pregabalin — DRUG
    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.
  • Pregabalin with dexmedetomidine — DRUG
    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.

Study Details

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.

Key Dates

First listed
Nov 17, 2025
Start date
Sep 30, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Monotherapy group
    Pregabalin
  • Experimental: Combination therapy group
    Pregabalin with dexmedetomidine

Primary Outcome Measure

The average pain intensity [ Time Frame: At the 4-weeks ]

Central Contacts

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