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Tests treatment safety and results for Fibromyalgia
Official title The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT07196657
What this study is testing
What is Pregabalin?
Pregabalin is an investigational medicine, given as an once-daily, being studied as a potential treatment for fibromyalgia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
- Aged over 18 years old;
- Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological...
- Baseline numeric rating scale (NRS) score of 4 or higher;
- Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;
You likely can't join if
- Previous allergic reactions to pregabalin, crisugabalin, or any of their excipients;
- Prior diagnosis of epilepsy or depression requiring antidepressant therapy;
- Women who are pregnant or breastfeeding;
- Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;
- Suffering from acute or chronic pain disorders other than FM.
See the full eligibility criteria
- Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
- Aged over 18 years old;
- Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM;
- Baseline numeric rating scale (NRS) score of 4 or higher;
- Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m²;
- Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements;
- Previous allergic reactions to pregabalin, crisugabalin, or any of their excipients;
- Prior diagnosis of epilepsy or depression requiring antidepressant therapy;
- Women who are pregnant or breastfeeding;
- Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;
- Suffering from acute or chronic pain disorders other than FM.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.