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AzTrials

Pain Associated With FibromyalgiaPhase 3NCT02234583

An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

A Phase 3 study testing DS-5565 in people with Pain Associated With Fibromyalgia, run by Daiichi Sankyo at 276 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain Associated With Fibromyalgia
What is being tested?
DS-5565
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,485 participants
Where
276 sitesin 29 countries
Study dates
4 Feb 2015to 19 Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to give written informed consent
  • Completed participation (i.e. completed the End-of-Tapering visit) in a preceding study of DS 5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)
  • Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
  • Able to complete subject-reported questionaires per the investigator's judgement
  • The subject must not have experienced any significant safety issues during the preceding study that, in the investigator's judgment, would adversely impact the subject's well-being in the long-term extension
  • De Novo Subjects
Show all 16Show fewer
  • Age ≥ 18 years
  • Able to give written informed consent
  • Able to complete subject-reported questionnaires per the investigator's judgment
  • At screening, subjects must meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
  • Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
  • Symptoms have been present at a similar level for at least 3 months
  • The subject does not have a disorder that would otherwise explain the pain
  • ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to first dose (based on completion of at least 4 daily pain diaries during the 7-day baseline period)
  • Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening
  • Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion

Who cannot join

  • Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease during the preceding study (for rollover subjects) or within 12 months prior to screening (for de novo subjects) that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
  • Subjects who are at risk of suicide as defined by their responses to the C-SSRS or in the opinion of the investigator.
  • Subjects with severe or uncontrolled depression that, in the judgment of the investigator, makes the subject inappropriate for entry into the study
  • Subjects with pain due to other conditions (e.g. DPNP or post-herpetic neuralgia) that, in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM
  • Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
  • Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
Show all 16Show fewer
  • A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
  • Known hypersensitivity to α2δ ligands or other components of the study medications
  • Pregnancy or breast-feeding, or intent to become pregnant during the study period
  • Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the investigator to be clinically significant at the End-of-Treatment visit (Visit - Week 13) in the preceding study (for rollover subjects) or at screening (for de novo subjects), with particular focus on:
  • For De Novo Subjects Only
  • Unable to undergo pre-study washout of prohibited concomitant medications (as listed in Section 5.2.1 of the protocol)
  • Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) interview (Version 6.0) at screening are excluded, but mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study
  • Any diagnosis of lifetime bipolar disorder or psychotic disorder
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
  • Subject is an employee of the study center, an immediate family member* of an employee of the study center, or an employee of Daiichi Sankyo, INC Research, or any of the study vendors supporting this study. *(spouse, parent, child, or sibling, whether biological or legally adopted)

Trial locations and contacts

276 sites in 29 countries.

276 sites in 29 countries

United States117 sites

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Alpharetta, Georgia, 30005

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Bellevue, Washington, 98007

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Billings, Montana, 59102

  • Study site

    Biloxi, Mississippi, 39531

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Blackwood, New Jersey, 08012

  • Study site

    Bolingbrook, Illinois, 60490

  • Study site

    Boston, Massachusetts, 02131

  • Study site

    Bradenton, Florida, 34201

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brooklyn, New York, 11230

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chicago, Illinois, 60634

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Columbus, Georgia, 31909

  • Study site

    Coral Springs, Florida, 33067

  • Study site

    Cromwell, Connecticut, 06416

  • Study site

    Dakota Dunes, South Dakota, 57049

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dayton, Ohio, 45417

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Fountain Inn, South Carolina, 29644

  • Study site

    Fresno, California, 93710

  • Study site

    Fresno, California, 93720

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hazelwood, Missouri, 63042

  • Study site

    Hialeah, Florida, 33013

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Kissimmee, Florida, 34744

  • Study site

    Knoxville, Tennessee, 37919

  • Study site

    Lake Charles, Louisiana, 70601

  • Study site

    Lakeland, Florida, 33805

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Leesburg, Florida, 34748

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Los Alamitos, California, 90720

  • Study site

    Los Angeles, California, 90036

  • Study site

    Lubbock, Texas, 79424

  • Study site

    Manhasset, New York, 11030

  • Study site

    Medford, Oregon, 97504

  • Study site

    Melrose Park, Illinois, 60160

  • Study site

    Miami, Florida, 33140

  • Study site

    Mobile, Alabama, 36608

  • Study site

    New Bedford, Massachusetts, 02740

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New Tazewell, Tennessee, 37836

  • Study site

    New York, New York, 10168

  • Study site

    Newport Beach, California, 92660

  • Study site

    Newton, Kansas, 67114

  • Study site

    North Massapequa, New York, 11758

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Orlando, Florida, 32801

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Paducah, Kentucky, 42003

  • Study site

    Phoenix, Arizona, 85018

  • Study site

    Plano, Texas, 75093

  • Study site

    Portland, Oregon, 97210

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Roseville, California, 95661

  • Study site

    Royal Palm Beach, Florida, 33411

  • Study site

    Salem, Oregon, 97301

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    San Antonio, Texas, 78232

  • Study site

    San Diego, California, 92103

  • Study site

    Santa Ana, California, 92705

  • Study site

    Santa Barbara, California, 93108

  • Study site

    Santa Monica, California, 90404

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Seattle, Washington, 98104

  • Study site

    Shawnee Mission, Kansas, 66218

  • Study site

    Smyrna, Georgia, 30080

  • Study site

    Spring Valley, California, 91978

  • Study site

    Springfield, Missouri, 65807

  • Study site

    St Louis, Missouri, 63141

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Sunrise, Florida, 33351

  • Study site

    Tampa, Florida, 33606

  • Study site

    Thousand Oaks, California, 91360

  • Study site

    Tiffin, Ohio, 44863

  • Study site

    Tipton, Pennsylvania, 16684

  • Study site

    Tullahoma, Tennessee, 37388

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tustin, California, 92780

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Watertown, Massachusetts, 02472

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    West Des Moines, Iowa, 50265

  • Study site

    Wichita, Kansas, 67205

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Willoughby, Ohio, 44094

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada18 sites

  • Study site

    Burlington, Ontario

  • Study site

    Kitchener, Ontario

  • Study site

    London, Ontario

  • Study site

    Markham, Ontario, L3R 9W9

  • Study site

    Markham, Ontario

  • Study site

    Mississauga, Ontario

  • Study site

    Newmarket, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Penticton, British Columbia

  • Study site

    Pointe-Claire, Quebec, H9R 3J1

  • Study site

    Québec, Quebec

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Sarnia, Ontario

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario, M3J 2C5

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

United Kingdom16 sites

  • Study site

    Atherstone, Warwickshire, CV9 1EU

  • Study site

    Belfast, Northern Ireland

  • Study site

    Blackpool, Lancashire

  • Study site

    Cannock, Staffordshire

  • Study site

    Chesterfield, Derbyshire

  • Study site

    Manchester, Greater Manchester

  • Study site

    North Shields, Tyne and Wear

  • Study site

    Penzance, Cornwall

  • Study site

    Romford, Essex

  • Study site

    Salford, Manchester

  • Study site

    Southport, Merseyside

  • Study site

    Stourton, Leeds

  • Study site

    Thornton-Cleveleys, Lancashire

  • Study site

    Torpoint

  • Study site

    Wellingborough, Northamptonshire

  • Study site

    Wigan, Lancashire

Other trials in United Kingdom

Australia12 sites

  • Study site

    Camperdown, New South Wales

  • Study site

    Campsie, New South Wales

  • Study site

    Clayton, Victoria

  • Study site

    Coffs Harbour, New South Wales

  • Study site

    Hobart, Tasmania

  • Study site

    Malvern East, Victoria

  • Study site

    Maroochydore, Queensland

  • Study site

    Sherwood, Queensland, 4075

  • Study site

    Sherwood, Queensland

  • Study site

    Southport, Queensland

  • Study site

    St Leonards, New South Wales

  • Study site

    Woodville, South Australia

Other trials in Australia

Poland11 sites

  • Study site

    Elblag

  • Study site

    Gdansk

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Nadarzyn

  • Study site

    Nowa Sól

  • Study site

    Torun

  • Study site

    Tychy

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Bulgaria8 sites

  • Study site

    Burgas

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sevlievo

  • Study site

    Sofia

  • Study site

    Targovishte

  • Study site

    Varna

Other trials in Bulgaria

Germany8 sites

  • Study site

    Berlin

  • Study site

    Böhlen

  • Study site

    Dresden

  • Study site

    Hanover

  • Study site

    Leipzig

  • Study site

    Magdeburg

  • Study site

    Mainz

  • Study site

    Stadtroda

Other trials in Germany

Ukraine8 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kherson

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Latvia7 sites

  • Study site

    Baldone

  • Study site

    Balvi

  • Study site

    Jēkabpils

  • Study site

    Liepāja

  • Study site

    Ogre

  • Study site

    Riga

  • Study site

    Ventspils

Other trials in Latvia

Slovakia7 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Dubnica nad Váhom

  • Study site

    Galanta

  • Study site

    Krompachy, 05342

  • Study site

    Piešťany

  • Study site

    Prešov

Other trials in Slovakia

South Africa7 sites

  • Study site

    Bayview, Chatsworth

  • Study site

    Cape Town, Western Cape

  • Study site

    Durban, KwaZulu-Natal

  • Study site

    Johannesburg, Gautang

  • Study site

    Pretoria, Gautang

  • Study site

    Somerset West, Western Cape

  • Study site

    Stellenbosch

Other trials in South Africa

Norway6 sites

  • Study site

    Ålesund

  • Study site

    Hamar

  • Study site

    Hønefoss

  • Study site

    Kløfta

  • Study site

    Lillehammer

  • Study site

    Stavanger

Other trials in Norway

Czechia5 sites

  • Study site

    Choceň

  • Study site

    Pilsen

  • Study site

    Prague

  • Study site

    Říčany

  • Study site

    Rychnov nad Kněžnou

Other trials in Czechia

New Zealand5 sites

  • Study site

    Auckland

  • Study site

    Hamilton

  • Study site

    Nelson

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

Hungary4 sites

  • Study site

    Balassagyarmat

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Nyíregyháza

Other trials in Hungary

Portugal4 sites

  • Study site

    Aveiro

  • Study site

    Guimarães

  • Study site

    Porto

  • Study site

    Vila Nova de Gaia

Other trials in Portugal

Russia4 sites

  • Study site

    Krasnoyarsk

  • Study site

    Moscow

  • Study site

    Nizhniy Novgarad

  • Study site

    Stavropol

Other trials in Russia

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Granada

  • Study site

    Madrid

  • Study site

    Santiago de Compostela, A Coruna

Other trials in Spain

Austria3 sites

  • Study site

    Klagenfurt

  • Study site

    Senftenberg

  • Study site

    Vienna, 1090

Other trials in Austria

France3 sites

  • Study site

    Douai, Nord

  • Study site

    Élancourt

  • Study site

    Saint-Etienne, Cedex

Other trials in France

Lithuania3 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Vilnius

Other trials in Lithuania

Romania3 sites

  • Study site

    Bacau

  • Study site

    Bucharest

  • Study site

    Târgu Mureş

Other trials in Romania

Chile2 sites

  • Study site

    Antofagasta, Region 11

  • Study site

    Puerto Varas, Region X

Other trials in Chile

Denmark2 sites

  • Study site

    Aalborg

  • Study site

    Odense

Other trials in Denmark

Estonia2 sites

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

Finland2 sites

  • Study site

    Hyvinkää

  • Study site

    Kuopio

Other trials in Finland

Puerto Rico2 sites

  • Study site

    Ponce, 00716

  • Study site

    San Juan, 00909

Other trials in Puerto Rico

Slovenia2 sites

  • Study site

    Ljubljana

  • Study site

    Slovenj Gradec

Other trials in Slovenia

Serbia1 site

  • Study site

    Belgrade

Other trials in Serbia

About this study

Official title: An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.

Being tested
DS-5565
Keywords
pain, fibromyalgia
Medical subject headings
Pain, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-5565Drug

    Also called Investigational product

    DS-5565 15 mg tablet for oral administration

Study groups in NCT02234583
Study groupRoleWhat they receive
DS-5565ExperimentalParticipants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.
Receives: Drug: DS-5565

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Daily Pain Score (ADPS) for DS-5565

    Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.

    Measured: Day 0 (baseline) up to to Week 52 postdose

Secondary outcomes (5)

  1. Number of Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change

    Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" status are reported.

    Measured: Week 52 postdose

  2. Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565

    The HADS questionnaire is a self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale from 0 to 3, where higher scores indicate greater anxiety or depression. Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.

    Measured: Day 0 (baseline) up to Week 52 postdose

  3. EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565

    The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.

    Measured: Day 0 (baseline) up to Week 52 postdose

  4. Short Form-36 (SF-36) Measure for DS-5565

    The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 physical component summary and mental component summary scales range from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) total scores at baseline and Week 52 are reported.

    Measured: Day 0 (baseline) to Week 52 postdose

  5. Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565

    Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.

    Measured: Day 0 (baseline) up to Week 52 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2014 (estimated)
  2. Study start4 Feb 2015
  3. Primary completion19 Apr 2017
  4. Study completion19 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,485 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02234583
Sponsor's protocol ID
DS5565-A-E312
Other IDs
2013-005164-26
Status last verified
Jul 2020
First submitted
4 Sep 2014
Last updated
23 Jul 2020
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

    PubMed 31284771

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DS-5565 in people with Pain Associated With Fibromyalgia, run by Daiichi Sankyo at 276 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 276 sites in United States, Canada, United Kingdom, Australia, Poland and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Daily Pain Score (ADPS) for DS-5565 (time frame: Day 0 (baseline) up to to Week 52 postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02234583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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