NCT07208357 The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia
| NCT ID | NCT07208357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 384 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 384 participants in total. It began in 2025-10-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria; * Aged 18 years or older; * Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM; * Numeric rating scale (NRS) score ≥ 4 at baseline; * Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal; * Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher; * Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements. Exclusion criteria * History of hypersensitivity to pregabalin, toludesvenlafaxine or any of its excipients; * History of epilepsy, or depression requiring antidepressant medications; * Pregnancy or breastfeeding; * Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction; * With acute or chronic pain conditions other than FM.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07208357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07208357 currently recruiting?
Yes, NCT07208357 is actively recruiting participants. Contact the research team at 13611326978@163.com for enrollment information.
Where is the NCT07208357 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07208357 clinical trial?
NCT07208357 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 384 participants.
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