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Trial record 20 of 103 for:    fibromyalgia | Open Studies | Interventional Studies

A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT03092726
First received: March 10, 2017
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to assess analgesic efficacy of ASP8062 relative to placebo as well as the safety and tolerability. This study will also assess the treatment differences in physical function as well the improvements in overall subject status (e.g., fibromyalgia symptoms, global functioning) of ASP8062 relative to placebo.

Condition Intervention Phase
Fibromyalgia
Drug: ASP8062
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline to week 8 in mean daily average pain score assessed by NRS (0 to 10 scale) in the subject's daily e-diary [ Time Frame: Baseline and Week 8 ]
    Numerical Rating Scale (NRS) is a generic instrument for the assessment of pain, consisting of a single question that asks subjects to record the subjects daily average pain on an 11- point scale, where 0 anchors 'no pain' and 10 is 'pain as bad as you can imagine'. The recall period is the last 24 hours.

  • Safety assessed by incidence of treatment emergent adverse events (TEAES) [ Time Frame: Until End of Study (Day 85) ]
    Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.

  • Safety assessed by incidence of serious adverse events (SAES) [ Time Frame: Until End of Study (Day 85) ]
    Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.

  • Number of participants with laboratory value abnormalities and/or adverse events [ Time Frame: Up to Week 10 ]
    Number of participants with potentially clinically significant laboratory values.

  • Number of participants with vital signs abnormalities and/or adverse events [ Time Frame: Up to Week 10 ]
    Number of participants with potentially clinically significant vital sign values.

  • Safety assessed by 12- lead electrocardiogram (ECG) [ Time Frame: Up to Week 10 ]
    ECGs will be recorded with the subject in the supine position, after the subject has been lying down for approximately 5 minutes. There should be at least 5 minutes between ECG measurements in case a repeat is needed. Any clinically significant adverse changes on the ECG will be reported as Adverse Events (AEs).

  • Number of participants with physical exam abnormalities and/or adverse events [ Time Frame: Up to Week 10 ]
    Number of participants with potentially clinically significant physical exam values.

  • Safety as assessed by C-SSRS (evaluation of suicidal ideation and behavior) [ Time Frame: Up to Week 10 ]
    The Colombia Suicide Severity Rating Scale (C-SSRS) was developed as a screening tool to identify suicide risk. The interview asks subjects detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Response options and recall periods vary in accordance with the nature of the question.


Secondary Outcome Measures:
  • Subject's response defined as achieving ≥ 30 % reduction from baseline to Week 8 and End of Treatment (EOT) in mean daily average pain score assessed by NRS (0 to 10 scale) in the subject's daily diary [ Time Frame: Baseline, Week 8 and End of Treatment (Day 57) ]
    Numerical Rating Scale (NRS) is a generic instrument for the assessment of pain, consisting of a single question that asks subjects to record the subjects daily average pain on an 11- point scale, where 0 anchors 'no pain' and 10 is 'pain as bad as you can imagine'. The recall period is the last 24 hours.

  • Subject's response defined as achieving ≥ 50 % reduction from baseline to Week 8 and EOT in mean daily average pain score assessed by NRS (0 to 10 scale) in the subject's daily diary [ Time Frame: Baseline, Week 8 and End of Treatment (Day 57) ]
    Numerical Rating Scale (NRS) is a generic instrument for the assessment of pain, consisting of a single question that asks subjects to record the subjects daily average pain on an 11- point scale, where 0 anchors 'no pain' and 10 is 'pain as bad as you can imagine'. The recall period is the last 24 hours.

  • Change from baseline to Weeks 2, 4, 8, and EOT in the FIQR [ Time Frame: Baseline, Weeks 2, 4, 8, and End of Treatment (Day 57) ]
    The 21-item Fibromyalgia Impact Questionnaire Revised (FIQR) contains 3 domains: activities of daily living, overall impact, and symptoms. Subjects answer each question on an 11-pt NRS, with anchors appropriate to each question. The recall period is the last 7 days or, for the physical function domain, the last time the activity was performed if not within the 7 day recall period.

  • Overall subject improvement assessed by patient global impression of change (PGIC) at weeks 2, 4, 8, and EOT [ Time Frame: Baseline, Weeks 2, 4, 8, and End of Treatment (Day 57) ]
    The Patient Global Impression of Change (PGIC) is a self-administered 7-pt Likert scale that asks subjects to evaluate the subject's fibromyalgia relative to baseline. The PGIC is anchored by "very much improved" and "very much worse."


Estimated Enrollment: 178
Anticipated Study Start Date: April 17, 2017
Estimated Study Completion Date: August 13, 2018
Estimated Primary Completion Date: August 13, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP8062
A single oral dose to be taken preferably in the morning with or without food
Drug: ASP8062
oral
Placebo Comparator: Placebo
A single oral dose to be taken preferably in the morning with or without food
Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a body mass index (BMI) ≤ 45 kg/m2.
  • Female subject must either:

    • Be of nonchildbearing potential:
    • Postmenopausal (defined as at least 1 year without any menses) prior to Screening, or,
    • Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
    • Or, if of childbearing potential, agree not to try to become pregnant during the study and for 28 days after the final study drug administration, have a negative blood pregnancy test at Screening and negative urine test on Day 1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.
  • Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration.
  • Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration.
  • Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration.
  • A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:

    • Agree to use a male condom starting at screening and continue throughout study treatment and for 28 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile the male subjects female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment, and for 28 days after the male subject receives final study drug administration.
  • Male subject with a partner of child-bearing potential, or a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period and for 28 days after the final study drug administration.
  • Subject meets the American College of Rheumatology (ACR) 1990 fibromyalgia diagnostic criteria at Screening:

    • Widespread pain for at least 3 months, defined as the presence of all of the following: Pain above and below the waist and Pain in the axial skeleton (cervical spine or anterior chest or thoracic spine or low back) must be present.
    • Pain in at least 11 of 18 tender point sites on digital palpation. Digital palpation should be performed with an approximate force of 4 kg.
  • Subject meets the ACR 2010 fibromyalgia diagnostic criteria at Screening:

    • Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 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.
  • Subject has a pain score ≥ 4 on the revised fibromyalgia impact questionnaire (FIQR) pain item at Screening.
  • Subject is compliant with daily pain recordings during the Baseline Diary Run-In period, as defined by the completion of a minimum of 5 of 7 daily average pain ratings and agrees to complete daily diaries throughout the duration of the study.
  • Subject has a mean daily average pain score ≥ 4 and ≤ 9 on an 11-point 0 to 10 NRS as recorded in the subject e-diary during the Baseline Diary Run-In period, and meeting pre-specified criteria for daily average pain scores.
  • Subject agrees to use only acetaminophen as rescue medication for fibromyalgia pain throughout the course of the trial (up to 1000 mg per dose and not to exceed 3000 mg/day).
  • Subject agrees not to initiate or change any non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) during the course of the study. Non-pharmacologic interventions must be stable for a minimum of 30 days prior to Screening. And subject agrees to maintain usual level of activity for the duration of the study.
  • Subject is capable of completing study assessments and procedures.
  • Subject agrees not to participate in another interventional study from Screening through the End of Study (EOS) visit.

Exclusion Criteria:

  • Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening.
  • Subject has had no meaningful improvement from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes).
  • Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP8062.
  • Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subject's fibromyalgia pain or require excluded therapies during the subject's study participation.
  • Subject has infectious or inflammatory arthritis (for example, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout), autoimmune disease (for example, systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia.
  • Subject has a current, untreated moderate or severe major depressive disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). Subject with current, treated major depressive disorder can be included provided that it is without clinically significant changes in symptoms while on the same dose of a protocol allowed antidepressant for greater than 60 days prior to Screening.
  • Subject has initiated any non-pharmacologic interventions for the treatment of fibromyalgia or depression within 30 days prior to Screening or during the Screening period.
  • Subject has a history of any psychotic and/or bipolar disorder as assessed by the M.I.N.I.
  • Subject has a Hospital Anxiety and Depression Scale (HADS) score > 14 on the Depression subscale at Screening or at the time of Visit 3 (Randomization).
  • Subject has a history of suicide attempt or suicidal behavior within the last 12 months, or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale C-SSRS]), or who is at significant risk to commit suicide at Screening and at the time of Visit 3 (Randomization).
  • Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine > 1.5x the ULN at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
  • Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of the reference range at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
  • Subject has a positive test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV [IgM]) or hepatitis C virus antibodies (anti-HCV) at Screening or has history of a positive test for human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2).
  • Subject has a resting systolic blood pressure > 180 mmHg or < 90 mmHg, and/or a sitting diastolic blood pressure > 100 mmHg at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
  • Subject has a clinically significant abnormality on 12-lead electrocardiogram (ECG) at Screening or Visit 3 (Randomization). If the ECG is abnormal an additional ECG can be carried out. If this also gives an abnormal result, the subject must be excluded.
  • Subject has a history of myocardial infarction (within 6 months of Screening), unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease or a family history of Long QT Syndrome.
  • Subject has evidence of any clinically significant, uncontrolled cardiovascular, gastrointestinal, endocrinologic (low thyroid stimulating hormone [TSH], but euthyroid is allowed), hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary (including obstructive sleep apnea not controlled by a continuous positive airway pressure device) neurologic, dermatologic, psychiatric, renal and/or other major disease (exclusive of fibromyalgia).
  • Subject has planned surgery during the study participation.
  • Subject has an active malignancy or a history of malignancy (except for treated nonmelanoma skin cancer) within 5 years of Screening.
  • Subject has a positive drug or alcohol test at Screening, Baseline Diary Run-In or prior to Randomization. However, a positive test for tetrahydrocannabinol (THC) and/or opioids is allowed at the Screening visit, but must be confirmed negative prior to Baseline Diary Run-In and Randomization.
  • Subject has a current or recent (within 12 months of Screening) history of a substance use disorder including cannabinoid and/or alcohol abuse disorder. Subject has used opioids for pain for more than 4 days during the week preceding the Screening visit.
  • Subject is currently using protocol specified prohibited medications and is unable to wash-out including over-the-counter (OTC) products and grapefruit and/or grapefruit juice.
  • Subject has filed or is awaiting judgment on a disability claim or has any pending worker's compensation litigation or related monetary settlements.
  • Subject has any condition which makes the subject unsuitable for study participation.
  • Subject is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site personnel directly affiliated with this study and/or immediate families (spouse, parent, child, or sibling, whether biological or legally adopted).
  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: NCT03092726

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 astellas.registration@astellas.com

Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Executive Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03092726     History of Changes
Other Study ID Numbers: 8062-CL-0101
Study First Received: March 10, 2017
Last Updated: April 6, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc:
ASP8062
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 24, 2017