ArticleJournal of pain research2020
Efficacy and Safety of ASP0819 in Patients with Fibromyalgia: Results of a Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.
Article in Journal of pain research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03056690 (A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Effects of pharmacological and non-pharmacological interventions for the management of sleep problems in people with fibromyalgia: a multi-methods evidence synthesis.Health technology assessment (Winchester, England) · 2025Pooled it
- Assessing Ethnic Minority Representation in Fibromyalgia Clinical Trials: A Systematic Review of Recruitment Demographics.International journal of environmental research and public health · 2023Pooled it
- Article
- The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients: Protocol for a Prospective Randomized Open Blinded-Endpoint (PROBE) Study.Journal of pain research · 2026Article
- Pharmacologic treatment of fibromyalgia: an update.Frontiers in pharmacology · 2025Review
- Peripheral Voltage-Gated Cation Channels in Neuropathic Pain and Their Potential as Therapeutic Targets.Frontiers in pain research (Lausanne, Switzerland) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeASP0819 is a novel, non-opioid K PATIENTS AND
methodsIn 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.
resultsThere was no statistically significant difference between ASP0819 and placebo for the primary endpoint (
conclusionASP0819 demonstrated some signals suggestive of efficacy and had a good tolerability profile in patients with fibromyalgia. Further studies are required to determine if ASP0819 can be a novel non-opioid treatment option in this patient group. CLINICALTRIALSGOV REGISTRATION: NCT03056690.
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Registered trials
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