Pregabalin plus desvenlafaxine for fibromyalgia pain

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

This test will try whether adding desvenlafaxine to pregabalin gives better pain relief for adults with moderate to severe fibromyalgia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 384 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07171320 on ClinicalTrials.gov

What this trial studies

This interventional study will compare pregabalin alone to pregabalin combined with desvenlafaxine in adults with moderate to severe fibromyalgia. Participants meeting the 2016 fibromyalgia diagnostic criteria and a baseline pain NRS ≥4 will be enrolled and assigned to one of the two medication regimens. Outcomes include measures of pain relief and monitoring for adverse effects, with laboratory checks for liver and kidney function. The trial aims to determine if adding desvenlafaxine, an SNRI with a potentially lower side-effect profile, increases the proportion of patients achieving meaningful pain reduction.

Who should consider this trial

Good fit: Adults aged 18 or older diagnosed with fibromyalgia by the 2016 criteria, with moderate to severe symptoms (NRS ≥4), adequate liver and kidney function, and not currently on recommended pharmacologic treatment for fibromyalgia.

Not a fit: Patients with hypersensitivity to either drug, a history of epilepsy or depression requiring antidepressant medications, pregnancy or breastfeeding, or serious uncontrolled systemic disease (including uncontrolled hypertension) are excluded and likely would not benefit from participation.

Why it matters

Potential benefit: If successful, combining desvenlafaxine with pregabalin could provide greater pain relief without a large increase in side effects.

How similar studies have performed: Pregabalin and SNRIs such as duloxetine have shown benefit separately for fibromyalgia, but the specific combination of pregabalin with desvenlafaxine is relatively novel and less 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, desvenlafaxine 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, M.D.

Conditions: Fibromyalgia, Pregabalin, Pain