Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,270 people across four groups to study treatments for fibromyalgia — a condition involving widespread pain and fatigue. Participants were randomly assigned to receive either a placebo (a dummy treatment with no active ingredient), pregabalin 150 mg twice daily, DS-5565 15 mg once daily, or DS-5565 15 mg twice daily. The main thing being measured was how much each person's daily pain score changed over 13 weeks, rated on a scale from 0 (no pain) to 10 (worst possible pain). Between 221 and 249 people in each group completed the full 13 weeks. The reported data shows that all four groups had lower average daily pain scores by week 13 compared to where they started. The placebo group's average score fell by 1.86 points, the pregabalin group's fell by 2.47 points, the DS-5565 once-daily group's fell by 2.24 points, and the DS-5565 twice-daily group's fell by 2.09 points. For the secondary measures — which looked at overall wellbeing, fatigue, anxiety, depression, and how participants rated their own overall change — all groups also reported lower (improved) scores by week 13. For example, when asked to rate their overall impression of change, 91 people in the placebo group, 141 in the pregabalin group, 116 in the DS-5565 once-daily group, and 117 in the DS-5565 twice-daily group said they felt "much improved or better." Similar patterns of change across all groups were reported for fatigue, anxiety, and depression scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 31284771) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Fibromyalgia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- You are able to sign a written consent form agreeing to take part in the study
- You are able to fill out questionnaires about how you are feeling, as judged by the study doctor
- You have been diagnosed with fibromyalgia according to specific medical guidelines — this includes having widespread pain for at least 3 months, pain in at least 11 out of 18 specific tender points on your body, and meeting certain pain and symptom scoring requirements (confirm with trial site)
- Your average daily pain score has been at least 4 out of 10 over the 7 days before you officially join the study, based on completing at least 4 daily pain diary entries during that time
- You have had an eye examination (with dilated pupils) within the past 12 months, or are willing to have one at the start of the study
- If you are a woman who could become pregnant, you must be using a reliable form of birth control during the study and for 4 weeks after it ends
Who may not be able to join:
- You have a serious or unstable medical condition affecting your nervous system, mental health, eyes, liver, lungs, blood, or heart (such as very low blood pressure, uncontrolled irregular heartbeat, or a heart attack in the past 12 months) that the study doctor believes would interfere with your participation
- You are planning to start or significantly change your exercise routine, or need to take other pain treatments during the study that could affect the results
- You are not able to stop taking certain medications before the study begins, as required by the study rules
- You are considered to be at risk of suicide, including if you have had any active thoughts, plans, or behaviours related to suicide in the past 12 months (as measured by a specific questionnaire)
- You currently have severe or uncontrolled major depression or an anxiety disorder (mild to moderate depression or anxiety may be allowed if the study doctor considers you stable enough to participate)
- You have ever been diagnosed with bipolar disorder or a psychotic disorder
- You have pain caused by another condition — such as nerve pain from diabetes or shingles — that could make it hard to tell apart from fibromyalgia pain
- You have widespread pain or inflammation caused by another condition such as rheumatoid arthritis or lupus
- You have misused or been dependent on prescription drugs, illegal drugs, or alcohol within the past year
- You have had any cancer other than a specific type of minor skin cancer (basal cell carcinoma) within the past 5 years
- You have untreated sleep apnea, or you have started treatment for sleep apnea within the past 3 months
- You are currently pregnant, breastfeeding, or planning to become pregnant during the study
- You are currently taking part in another clinical trial, or it has been fewer than 30 days since you finished one
- You have a known allergy or sensitivity to the type of medication being studied (confirm with trial site)
- The study doctor believes you are unlikely to follow the study rules or complete all required visits
- Your blood or heart test results at the start of the study are significantly abnormal, particularly those related to kidney function, liver function, or muscle health (confirm specific values with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Global Clinical Leader, Daiichi Sankyo
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
11 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.