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

NCT07208357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2025-11-17

No results posted yet for this study

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. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of toludesvenlafaxine in FM. We hypothesize that the combination of pregabalin with toludesvenlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Conditions

  • Fibromyalgia
  • Pregabalin
  • Duloxetine
  • Pain

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 toludesvenlafaxine

In the pregabalin with toludesvenlafaxine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. Toludesvenlafaxine will be administered at 40 mg daily initially. If the initial dose is well-tolerated, the dose could be further escalated by 40 mg per day after 7 days, up to a maximum of 160 mg per day. With each dose increase, AEs will be assessed and categorized as mild, moderate, or severe. If participants tolerate the current dose for 2 to 3 days, it will be maintained, with the expectation that tolerance to AEs will develop. If AEs become intolerable, the dose will be decreased back to the previous dose, which was defined as the maximum tolerated dose. In the combination group, dose titration of both pregabalin and toludesvenlafaxine will be conducted simultaneously. If AEs occur, the next dose regimen should be determined in consultation with a clinical physician.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-06-30
Completion
2027-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07208357 on ClinicalTrials.gov