Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease

Need for ongoing use of concomitant chronic pain medications or any new non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety, including neurolytic treatments (destruction of nerves by chemicals, heat, cold) or surgery, intrathecal pumps, spinal cord stimulators or psychological support within the previous year. Also excluded: topical capsaicin within 6 months; or systemic corticosteroids within 3 months of baseline period.

Unable to undergo pre-study washout of prohibited concomitant medications

Subjects with recent history (i.e., within 1 year prior to screening) of alcohol abuse or illicit drug use (cocaine, heroin, marijuana \[including medical, prescribed\], etc.)

Use of any selective serotonin reuptake inhibitor (SSRI), unless the subject has been on a stable dose for ≥ 90 days prior to screening and is not anticipated to need any dose adjustment during the course of the study

Subjects with severe or uncontrolled depression that, in the judgment of the Investigator, makes the subject inappropriate for entry into the study

Significant neurological or psychiatric disorder unrelated to neuropathic pain

Other severe pain (eg, sciatica, rheumatoid arthritis) that might impair the assessment of neuropathic pain

CrCl ≥ 60 mL/min estimated from serum creatinine by the central laboratory using the Cockcroft-Gault equation.

Subjects who are on hemodialysis or who require hemodialysis before the follow-up assessment; acute renal failure; history of kidney transplant

Any history of a malignancy other than basal cell carcinoma within the past 5 years

Clinically significant unstable neurologic, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (eg, severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) within 12 months prior to screening

Pregnancy or breast feeding or intent to become pregnant during the study period

Known hypersensitivity to α2δ ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.

Clinically significant ECG abnormalities at the Screening Visit

Subjects who are at risk of suicide, as defined by their responses to the C-SSRS or in the opinion of the Investigator. Note: Subjects answering "yes" to any of the questions about active suicidal ideation/intent/behaviors that occurred within the past 12 months must be excluded (C-SSRS Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section - any of the suicide behaviors questions). Such subjects should be referred immediately to a mental health professional for appropriate evaluation.

Subjects who are unlikely to comply with the protocol (eg, uncooperative attitude, inability to return for subsequent visits, and/or otherwise considered by the Investigator to be unlikely to complete the study)

Subject is currently enrolled in, or it has been fewer than 30 days since ending, another investigational device or drug study or is receiving another investigational agent.

Subjects who are employees or immediate family of employees of the study site, Sponsor, or contract research organization (CRO)

Screening laboratory values outside the limits listed in the table below:

* Hematology

* Hemoglobin \< 8 g/dL

* Platelet count \< 100,000/mm3

* Absolute neutrophil count \< 1,500/mm3

* Blood chemistry

* AST \> 2.0 × ULN

* ALT \> 2.0 × ULN

* Alkaline phosphatase \> 1.5 × ULN

* Total bilirubin \> 1.2 × ULN (If a subject has total bilirubin \>ULN: unconjugated and conjugated bilirubin fractions should be analyzed and only subject documented to have Gilbert's syndrome may be enrolled)

* Creatine kinase \> 3.0 × ULN

* Calculated CrCl ≥ 60 mL/min

What this study is about