Fibromyalgia Clinical Trials

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Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients between ages over 18 years with proper cognitive function and language skills for the study;

• Patients diagnosed with FM as defined by the ACR FM diagnostic criteria;

• Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM;

• A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline.

Locations
Other Locations
China
Beijing Tiantan Hospital, Beijing, Beijing 100070
RECRUITING
Beijing
Contact Information
Primary
Fang Luo
15383510462@163.com
+8613611326978
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 106
Treatments
Active_comparator: Control group
Pregabalin and venlafaxine concomitant therapy
Experimental: Treatment group
Esketamine plus pregabalin and venlafaxine concomitant therapy
Related Therapeutic Areas
Sponsors
Collaborators: Beijing Ditan Hospital, Beijing Sanbo Brain Hospital
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov