Clinical trial NCT05008835: Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis Pain
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Investment, LLC
state: Alabama
city: Birmingham
country: United States
facility: AOC-Research
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: San Diego
country: United States
facility: Artemis Headlands, LLC
state: California
city: San Diego
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: M&M Medical Center
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research,LLC
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Flossmoor
country: United States
facility: Health Research Network II, LLC
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health Corp.
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Meridian Hills
country: United States
facility: Velocity Clinical Research-Boise
state: Indiana
city: Wichita
country: United States
facility: AMR Wichita West
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC.
state: Kentucky
city: Watertown
country: United States
facility: Bay State Clinical Trials
state: Massachusetts
city: Hazelwood
country: United States
facility: Healthcare Research Network, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: AMR Las Vegas
state: Nevada
city: Hartsdale
country: United States
facility: Drug Trials America, Inc.
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas,LLC
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
Study officials:
References: