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



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 2015
End Date:April 2017

Use our guide to learn which trials are right for you!

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, DS5565-A-E310,
or DS5565-A-E311 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.


Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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)
We found this trial at
117
sites
?
mi
from
Alpharetta, GA
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Biloxi, MS
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Blackwood, NJ
Click here to add this to my saved trials
?
mi
from
Bolingbrook, IL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Brandon, FL
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Camperdown,
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
?
mi
from
Cromwell, CT
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
?
mi
from
Fall River, MA
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fountain Inn, South Carolina 29644
?
mi
from
Fountain Inn, SC
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Gurnee, IL
Click here to add this to my saved trials
?
mi
from
Hazelwood, MO
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Kettering, OH
Click here to add this to my saved trials
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Leesburg, FL
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Melrose Park, IL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
New Bedford, Massachusetts 02740
?
mi
from
New Bedford, MA
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New Tazewell, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Newton, KS
Click here to add this to my saved trials
North Massapequa, New York 11758
?
mi
from
North Massapequa, NY
Click here to add this to my saved trials
?
mi
from
Oak Brook, IL
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Paducah, KY
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rancho Mirage, California 90070
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Royal Palm Beach, FL
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
Salem, OR
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Savannah, GA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
?
mi
from
Smyrna, GA
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
?
mi
from
Springfield, MO
Click here to add this to my saved trials
?
mi
from
Sunrise, FL
Click here to add this to my saved trials