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Efficacy and Safety of ASP0819 in Patients with Fibromyalgia: Results of a Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
- Source :
- Journal of Pain Research. 13:3355-3369
- Publication Year :
- 2020
- Publisher :
- Informa UK Limited, 2020.
-
Abstract
- Purpose ASP0819 is a novel, non-opioid KCa3.1 channel opener that reverses abnormal nerve firing of primary sensory afferent nerves. Currently available treatments for fibromyalgia provide only modest relief and are accompanied by a host of adverse side effects. Patients and Methods In this phase 2a, double-blind trial (NCT03056690), adults meeting fibromyalgia diagnostic criteria were randomized 1:1 to receive either 15 mg/day of oral ASP0819 (n=91) or placebo (n=95). The primary endpoint was the change from baseline to Week 8 in the mean daily average pain score. Changes in the Fibromyalgia Impact Questionnaire Revised (FIQR) symptoms, function, and overall impact subscales, as well as changes in the patients’ global impression of change, were secondary endpoints; treatment effects on FIQR total score and impact on sleep were exploratory analyses. Results There was no statistically significant difference between ASP0819 and placebo for the primary endpoint (P=0.086); however, ASP0819 versus placebo significantly improved daily average pain at Weeks 2, 6, and 7 (all P
- Subjects :
- medicine.medical_specialty
business.industry
Placebo-controlled study
medicine.disease
Placebo
Clinical trial
Substance abuse
03 medical and health sciences
0302 clinical medicine
Anesthesiology and Pain Medicine
Tolerability
030202 anesthesiology
Internal medicine
Fibromyalgia
Clinical endpoint
medicine
Adverse effect
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 11787090
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Journal of Pain Research
- Accession number :
- edsair.doi...........b71cd1dbd034ec2ee898280d14f4f797