Osteoarthritis Pain

  • sponsor
    ACADIA Pharmaceuticals Inc.
Updated on 21 April 2022


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


  • Condition: Osteoarthritis Pain
  • Clinical Trial Identifier: NCT05008835
  • Sponsor: ACADIA Pharmaceuticals Inc.

Condition Osteoarthritis
Clinical Study IdentifierTX290598
SponsorACADIA Pharmaceuticals Inc.
Last Modified on21 April 2022


Yes No Not Sure

Inclusion Criteria

Male or female subjects ≥18 and <65 years of age at the time of Screening
Confirmed history of pain associated with OA in the index knee
Willing to maintain current activity and exercise levels throughout the study

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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