Trial record 37 of 99 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Daiichi Sankyo Inc.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02496884
First received: July 8, 2015
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia pain. Because it is metabolized through the kidneys, people who have reduced kidney function will not process the drug as well as with those with normal kidney function, so the dose must be reduced. This study will test two reduced dose levels for both moderately reduced and severely reduced kidney function. The study will test the hypothesis that the drug will be safe and well-tolerated in people who have both fibromyalgia and chronic kidney disease.

Condition Intervention Phase
Fibromyalgia
Drug: DS-5565
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Safety Study of DS-5565 for Treatment of Pain Due to Fibromyalgia in Subjects With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • measure the frequency of Adverse Events [ Time Frame: baseline through end of week 13 ]
    To determine the safety and tolerability of subjects with FM and moderate to severe renal dysfunction during 13 weeks of renally adjusted dosing of DS-5565 compared to placebo by measuring the frequency of Treatment Emergent Adverse Events (TEAE).


Secondary Outcome Measures:
  • change in Average Daily Pain Score (ADPS) for each dose DS-5565 versus placebo [ Time Frame: baseline to week 13 ]
    To compare change in weekly average pain as assessed by average daily pain score (ADPS) from baseline measured at randomization to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes the worst pain over the previous 24 hours

  • percent change in patient global impression of change (PGIC) scores [ Time Frame: up to week 13 ]
    To measure the change in patient global impression of change (PGIC) up to Week 13


Estimated Enrollment: 60
Study Start Date: June 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FM with moderate chronic kidney disease
7.5 mg tablets twice per day
Drug: DS-5565
7.5 mg tablet DS-5565
Experimental: FM with severe chronic kidney disease
7.5 mg tablet once per day, placebo once per day
Drug: DS-5565
7.5 mg tablet DS-5565
Drug: placebo
placebo tablet to match 7.5mg tablet DS-5565
Placebo Comparator: placebo
placebo tablets twice per day
Drug: placebo
placebo tablet to match 7.5mg tablet DS-5565

Detailed Description:

This is a stratified, randomized, double-blind, placebocontrolled, multi-center safety study of DS-5565 in subjects with Fibromyalgia (FM) and renal dysfunction. Eligible subjects will be randomized 2:1 to receive either DS-5565 7.5 mg once daily (QD) or placebo for the category of subjects with creatinine clearance (CrCl) 15-29 mL/min, or 2:1 to receive treatment with DS-5565 7.5 mg twice daily (BID) or placebo for the category of subjects with CrCl 30-59 mL/min.

Subjects will be stratified for renal impairment by CrCl. The treatment period is 13 weeks in duration. The total study duration (individual subject) will be approximately 21 weeks. The study includes a screening period (approximately 3 weeks but no longer than 35 days, including a washout period [if necessary] and a 1-week baseline period), double-blind treatment period (13 weeks), and a 4 week follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Able to give written informed consent
  • Able to complete patient-reported questionnaires per the Investigator's judgment
  • Estimated CrCl between 15-59 mL/min from serum creatinine by the central laboratory using the Cockcroft-Gault equation
  • Fibromyalgia meeting American College of Rheumatology criteria for FM:

    • Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3 to 6 and SS scale score ≥ 9,
    • Pain in at least 11 of 18 specific tender point sites,
    • Symptoms have been present at a similar level for at least 3 months, and
    • The subject does not have a disorder that would otherwise explain the pain
  • Average Daily Pain Score of ≥ 4 on the 11-point numeric rating scale (NRS) over the 7 days prior to randomization (based on completion of at least 4 daily pain assessments during the 7-day baseline period prior to randomization)
  • Women of child bearing potential (WOCBP) must be using adequate methods of contraception to avoid pregnancy during the study and for 4 weeks after study completion.

Exclusion Criteria:

  • 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
    • Abbreviations: ALT = alanine aminotransferase, AST = aspartate *aminotransferase, CrCl = creatinine clearance (determined by the central laboratory using the Cockcroft-Gault equation), ULN = upper limit of normal . *C-SSRS = Columbia-Suicide Severity Rating Scale
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02496884

Contacts
Contact: INC Research SM_DS5565-A-U307Info@incresearch.com

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85018
United States, California
Recruiting
Colton, California, United States, 92324
Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Recruiting
Colorado Springs, Colorado, United States, 80918
United States, Florida
Recruiting
Brooksville, Florida, United States, 34601
Recruiting
Debary, Florida, United States, 32713
Recruiting
Hialeah, Florida, United States, 33013
Recruiting
Kissimmee, Florida, United States, 34744
Recruiting
Miami, Florida, United States, 33144
United States, Michigan
Recruiting
Grand Blanc, Michigan, United States, 48439
United States, North Carolina
Recruiting
High Point, North Carolina, United States, 27262
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45224
United States, Pennsylvania
Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Recruiting
Greer, South Carolina, United States, 29651
United States, South Dakota
Recruiting
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Recruiting
Knoxville, Tennessee, United States, 37919
United States, Texas
Recruiting
Houston, Texas, United States, 77098
Recruiting
Plano, Texas, United States, 75093
United States, West Virginia
Recruiting
Charleston, West Virginia, United States, 25304
Recruiting
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Daiichi Sankyo Inc.
INC Research
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02496884     History of Changes
Other Study ID Numbers: DS5565-A-U307 
Study First Received: July 8, 2015
Last Updated: July 20, 2016

Keywords provided by Daiichi Sankyo Inc.:
chronic kidney disease
. α2δ ligands
mirogabalin
pain relief
kidney metabolism

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 23, 2017