The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07196657
Status
Recruiting
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Conditions

  • Fibromyalgia
  • Pain
  • Pregabalin

Eligibility Criteria

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

Interventions

  • Pregabalin — DRUG
    For 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.
  • Crisugabalin — DRUG
    For the crisugabalin group, therapy will begin at 20 mg twice daily, with a maximum allowable dose of 40 mg twice daily.

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. crisugabalin, 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 crisugabalin in treating FM, with the aim of providing a better treatment option for FM patients.

Key Dates

First listed
Sep 29, 2025
Start date
Sep 30, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
1,116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pregabalin group
  • Experimental: Crisugabalin group

Primary Outcome Measure

The proportion of patients achieving pain relief [ Time Frame: At the 12-weeks ]

Central Contacts

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