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Tests treatment safety and results for Fibromyalgia
Official title The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT07230171
What this study is testing
What is Pregabalin and venlafaxine concomitant therapy?
Pregabalin and venlafaxine concomitant therapy 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 is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits.
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
- Patients between ages over 18 years with proper cognitive function and language skills for the study;
- Patients diagnosed with FM as defined by the ACR FM diagnostic criteria;
- Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended...
- A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline.
You likely can't join if
- Patient refusal;
- Inability to sign informed consent;
- Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder;
- Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder;
- Obstructive sleep apnea syndrome or a STOP-Bang score ≥ 3;
- History of treatment with pregabalin and/or venlafaxine for any disease;
See the full eligibility criteria
- Patients between ages over 18 years with proper cognitive function and language skills for the study;
- Patients diagnosed with FM as defined by the ACR FM diagnostic criteria;
- Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM;
- A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline.
- Patient refusal;
- Inability to sign informed consent;
- Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder;
- Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder;
- Obstructive sleep apnea syndrome or a STOP-Bang score ≥ 3;
- History of treatment with pregabalin and/or venlafaxine for any disease;
- History of treatment with intravenous ketamine or ESK for chronic pain;
- Presence of other painful ailments such as inflammatory rheumatic disease;
- Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to esketamine;
- History of prescription drug abuse, alcoholism or illicit drug use;
- Pregnant or lactating women;
- Allergic to any of the study drugs.
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.