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

Phase 2

Terminated

Conditions: Osteoarthritis Pain

Interventions: Drug: Placebo
Drug: ACP-044 Dose B
Drug: ACP-044 Dose A

Registration Number: NCT05008835

Lead Sponsor: ACADIA Pharmaceuticals Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 61

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Drug - ACP-044 Dose B	ACP-044 Dose B	ACP-044 Dose B
Drug - ACP-044 Dose A	ACP-044 Dose A	ACP-044 Dose A

Primary Outcome Measures

Name	Time	Method
Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores	4 weeks	The 0-10 NRS consists of a single 11-point numeric scale, with 0 indicating no pain at all and 10 reflecting the worst pain imaginable. Due to the business decision to discontinue clinical development of ACP-044, this study was prematurely terminated. Efficacy was not evaluated in this study by using (planned) inferential statistics. For the purpose of results posting, changes in NRS over time are displayed using descriptive statistics.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (32): Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸
Orlando, Florida, United States
Chase Medical Research, LLC
🇺🇸
Waterbury, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Memphis, Tennessee, United States
M&M Medical Center
🇺🇸
Miami, Florida, United States
Precision Clinical Research,LLC
🇺🇸
Sunrise, Florida, United States
Conquest Research
🇺🇸
Winter Park, Florida, United States
BioSolutions Clinical Research Center
🇺🇸
La Mesa, California, United States
Velocity Clinical Research-Boise
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Meridian Hills, Indiana, United States
Bay State Clinical Trials
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Watertown, Massachusetts, United States
Drug Trials America, Inc.
🇺🇸
Hartsdale, New York, United States
Healthcare Research Network, Inc.
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Hazelwood, Missouri, United States
AMR Las Vegas
🇺🇸
Las Vegas, Nevada, United States
Health Research of Hampton Roads
🇺🇸
Newport News, Virginia, United States
AMR Wichita West
🇺🇸
Wichita, Kansas, United States
Clinical Research Investment, LLC
🇺🇸
Birmingham, Alabama, United States
AOC-Research
🇺🇸
Birmingham, Alabama, United States
TriWest Research Associates, LLC
🇺🇸
San Diego, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸
North Hollywood, California, United States
Artemis Headlands, LLC
🇺🇸
San Diego, California, United States
Encompass Clinical Research
🇺🇸
Spring Valley, California, United States
Drug Studies America
🇺🇸
Marietta, Georgia, United States
Health Research Network II, LLC
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Flossmoor, Illinois, United States
Affinity Health Corp.
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Oak Brook, Illinois, United States
Medisphere Medical Research Center, LLC
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Evansville, Indiana, United States
Alliance for Multispecialty Research, LLC.
🇺🇸
Lexington, Kentucky, United States
Upstate Clinical Research Associates, LLC
🇺🇸
Williamsville, New York, United States
Hightop Medical Research Center
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Cincinnati, Ohio, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Clinical Investigations of Texas,LLC
🇺🇸
Plano, Texas, United States
Spectrum Medical, Inc.
🇺🇸
Danville, Virginia, United States
Future Search Trials
🇺🇸
Austin, Texas, United States