Pregabalin combined with toludesvenlafaxine for fibromyalgia pain

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Toludesvenlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

This trial will see if adding toludesvenlafaxine to pregabalin improves pain relief without causing more side effects for adults with moderate to severe fibromyalgia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 384 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07208357 on ClinicalTrials.gov

What this trial studies

Adults meeting the 2016 fibromyalgia diagnostic criteria and with baseline pain NRS ≥4 will receive either pregabalin alone or pregabalin plus toludesvenlafaxine and be monitored for pain changes and adverse events. Screening includes liver and kidney function checks and excludes people with epilepsy, antidepressant-treated depression, pregnancy, or serious uncontrolled systemic disease. Outcomes will focus on pain intensity reduction and safety/tolerability measures reported during the treatment period. The comparison aims to determine whether the combination provides superior symptom control without a meaningful increase in side effects.

Who should consider this trial

Good fit: Adults (≥18) diagnosed with fibromyalgia by the 2016 criteria, with moderate-to-severe symptoms (NRS ≥4), adequate liver and kidney function, not currently receiving recommended FM pharmacotherapy, and able to consent and comply with visits.

Not a fit: People with a history of epilepsy, active depression requiring antidepressants, pregnancy or breastfeeding, known allergy to pregabalin or toludesvenlafaxine, uncontrolled serious systemic disease, or severe hepatic/renal impairment are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the combination could provide greater pain relief for people with fibromyalgia without substantially increasing side effects.

How similar studies have performed: SNRIs like duloxetine have shown benefit in fibromyalgia and early work on toludesvenlafaxine is promising, but combining toludesvenlafaxine with pregabalin is relatively novel and not yet widely tested.

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Fibromyalgia; Pregabalin; Duloxetine; Pain