Pregabalin plus dexmedetomidine for reducing pain and improving sleep in fibromyalgia

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Dexmedetomidine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

This trial will try combining pregabalin with dexmedetomidine to reduce pain and improve sleep in adults with moderate-to-severe fibromyalgia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07230197 on ClinicalTrials.gov

What this trial studies

Adults meeting the 2016 fibromyalgia diagnostic criteria with a baseline pain NRS ≥4 are enrolled and receive either pregabalin alone or pregabalin combined with dexmedetomidine. The trial compares pain relief rates, sleep quality, and adverse events between the two intervention groups during the treatment period. Participants must have acceptable liver and kidney function and cannot have epilepsy, depression requiring antidepressants, pregnancy, or serious uncontrolled systemic disease. Investigators hypothesize the combination will provide greater pain relief and better sleep without a substantial increase in side effects.

Who should consider this trial

Good fit: Adults (≥18) with moderate-to-severe fibromyalgia per the 2016 criteria, baseline NRS ≥4, acceptable liver and kidney tests, and who have not received recommended pharmacologic FM treatments are ideal candidates.

Not a fit: People with a history of epilepsy, depression requiring antidepressants, allergy to pregabalin or related drugs, pregnant or breastfeeding individuals, or those with serious uncontrolled systemic diseases are unlikely to be eligible and may not benefit.

Why it matters

Potential benefit: If successful, the combination could provide greater pain relief and improved sleep for people with fibromyalgia without substantially more adverse effects.

How similar studies have performed: Pregabalin is an established fibromyalgia medication but provides only partial relief for many patients, and while dexmedetomidine can improve sleep in other clinical contexts, combining it with pregabalin for fibromyalgia is novel and not well established.

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, venlafaxine 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, Dexmedetomidine