Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee

  • STATUS
    Recruiting
  • End date
    Jan 25, 2023
  • participants needed
    240
  • sponsor
    ACADIA Pharmaceuticals Inc.
Updated on 25 November 2021

Summary

To evaluate the efficacy of ACP-044 compared with placebo in the treatment of pain associated with osteoarthritis of the knee

Details
Condition Osteoarthritis Pain
Treatment Placebo, ACP-044 Dose A, ACP-044 Dose B
Clinical Study IdentifierNCT05008835
SponsorACADIA Pharmaceuticals Inc.
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects 18 and <65 years of age at the time of Screening
Has a body mass index (BMI) 39 kg/m2 at Screening
Confirmed history of pain associated with OA in the index knee
Willing to maintain current activity and exercise levels throughout the study
Willing and able to comply with clinic visits and study-related procedures
Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere to be shared with the Investigator and third parties who will examine the images (i.e., central x-ray reader)

Exclusion Criteria

Pain anywhere else in the body which is greater than or equal to OA pain in the index knee, or likely to interfere with subject's assessment of pain throughout the study, as judged by the Investigator
History or presence on imaging of knee arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), recent fall, injury, or trauma affecting the index knee, ligament tear, neuropathic joint arthropathy, knee dislocation (patella dislocation is eligible), extensive subchondral cysts, Baker's cyst, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas, or pathological fractures during the Screening Period
History or presence at Screening of non-OA inflammatory joint disease (e.g., rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, joint infections within the past 5 years, Paget's disease of the spine, pelvis, or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy) or any condition that would interfere with the rating of OA pain
Recent arthroscopic surgery within 1 month of Screening; or has any planned surgery or procedure during the study
Use of monoamine reuptake inhibitors, tricyclic antidepressants, anticonvulsants, and/or serotonin norepinephrine reuptake inhibitors within 4 weeks prior to Screening
Unwilling to discontinue current use of analgesic medication following Screening and to adhere to study requirements for rescue treatments (study-provided acetaminophen to be taken as needed with a maximum daily dose of 2500 mg), including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, selective cyclooxygenase 2 inhibitors, acetaminophen, or combinations thereof, within 7 days or five half-lives of the drug prior to the Baseline Pain Assessment Period, whichever is longer
Use of immediate- or extended-release or controlled-release opioids (e.g., oxycontin), transdermal fentanyl, or methadone within 3 months prior to Screening
Use of opioids, for the treatment of pain other than OA of the knee, with a morphine equivalent dose of 30 mg per day for more than 2 days per week within 1 month prior to Screening
Use of systemic (i.e., oral) corticosteroids or intra-articular corticosteroids in any joint within 30 days prior to the screening visit (topical, intranasal, and inhaled corticosteroids are permitted)
Intra-articular injection of any approved (i.e., hyaluronic acid and corticosteroids) or unapproved treatments (e.g., platelet-rich plasma, capsaicin) into the index knee within 3 months of Screening
Physical/occupational/chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or the need for such therapy during the study
Has current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, endocrinologic, or other medical disorder, that in the judgment of the Investigator and/or Medical Monitor would jeopardize the safe participation of the subject in the study
Had a malignancy in the last year, with the exception of nonmetastatic basal cell of the skin or localized carcinoma in situ of the cervix
Additional inclusion/exclusion criteria apply. Patients will be evaluated at
screening to ensure that all criteria for study participation are met
Patients may be excluded from the study based on these assessments (and
specifically, if it is determined that their baseline health and psychiatric
condition do not meet all pre-specified entry criteria)
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