Pregabalin plus venlafaxine for fibromyalgia pain

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

This trial tests whether adding venlafaxine to pregabalin gives better pain relief for adults with moderate-to-severe fibromyalgia than pregabalin alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 2 sites (Beijin and 1 other locations)
• Trial ID: NCT07186751 on ClinicalTrials.gov

What this trial studies

Adults who meet the 2016 fibromyalgia diagnostic criteria and report moderate-to-severe pain will receive either pregabalin alone or pregabalin combined with venlafaxine. The study compares pain reduction on an 11-point numeric rating scale and tracks adverse events to evaluate safety. Key exclusions include psychiatric disorders, pregnancy or breastfeeding, significant uncontrolled systemic disease, and other acute or chronic pain conditions. Participants will attend clinic visits at the study sites for drug administration and regular outcome assessments over the treatment period.

Who should consider this trial

Good fit: Adults over 18 with fibromyalgia by 2016 criteria who have moderate-to-severe pain (NRS > 4) and are not currently receiving recommended pharmacologic treatment for fibromyalgia are appropriate candidates.

Not a fit: People who are pregnant or breastfeeding, have psychiatric illness, contraindications to pregabalin or venlafaxine, uncontrolled major medical conditions, or other pain disorders are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the combination could provide greater pain relief than pregabalin alone without a meaningful increase in side effects.

How similar studies have performed: SNRIs such as duloxetine and some studies of venlafaxine have shown benefit in fibromyalgia, but evidence for combining venlafaxine with pregabalin is limited.

Eligibility criteria

Inclusion Criteria:

* Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
* Aged more than 18 years;
* Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
* Agreed to sign the informed consent form.

Exclusion criteria

* A history of psychiatric disease;
* Hypersensitivity or have contraindications to pregabalin, venlafaxine;
* Pregnancy or breastfeeding;
* Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction;
* With acute or chronic pain conditions other than FM.

Where this trial is running

Beijin and 1 other locations

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

Study contacts

• Study coordinator: Fang Luo

Conditions Fibromyalgia; Pregabalin; Venlafaxine; Pain