Pregabalin combined with toludesvenlafaxine for fibromyalgia pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Tiantan Hospital, Beijing, Beijing 100070
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: +8613611326978

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.