The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Pregabalin and venlafaxine concomitant therapy
DrugThe control group will only receive an increased dosage of pregabalin and venlafaxine regimen. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.
Esketamine plus pregabalin and venlafaxine concomitant therapy
DrugThe treatment group, in addition to the increased pregabalin and venlafaxine medication dosage regimen, will also receive a single intravenous infusion of esketamine on the day of enrollment. Plasma concentrations of esketamine and its metabolites will be measured at the end of infusion to enable a limited characterization of systemic exposure and to support exploratory exposure-response analyses. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the mean pain intensity
This outcome is calculated as the average of daily 24-hour pain intensity scores recorded in patient diaries over 7 consecutive days using NRS.
Time frame
At the week 1.Secondary outcomes
1
Average pain intensity
The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
At the weeks 1, 2, 4, 8, and 122
Worst pain intensity
The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
at weeks 1, 2, 4, 8, and 123
Proportion of patients achieving pain reduction at 50% and 30%;
The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
at weeks 1, 2, 4, 8, and 124
The median pain relief time
The median pain relief time, defined as the time of 50% decrease in NRS score from baseline. Pain intensity will be measured using the NRS, where 0 indicates no pain, and 10 represents the worst imaginable pain.
Time frame
Through study completion, an average of 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Beijing Ditan Hospital
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
Source ClinicalTrials.gov