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

NCT ID: NCT05008835

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2022-11-16

Brief Summary

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

Conditions

Osteoarthritis Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Drug - ACP-044 Dose A

ACP-044 Dose A

Group Type: EXPERIMENTAL

ACP-044 Dose A

Intervention Type: DRUG

Oral dose of ACP-044 Dose A

Drug - ACP-044 Dose B

ACP-044 Dose B

Group Type: EXPERIMENTAL

ACP-044 Dose B

Intervention Type: DRUG

Oral dose of ACP-044 Dose B

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

ACP-044 Dose A

Oral dose of ACP-044 Dose A

Intervention Type: DRUG

ACP-044 Dose B

Oral dose of ACP-044 Dose B

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Investment, LLC

Birmingham, Alabama, United States

AOC-Research

Birmingham, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

BioSolutions Clinical Research Center

La Mesa, California, United States

Velocity Clinical Research, North Hollywood

North Hollywood, California, United States

Artemis Headlands, LLC

San Diego, California, United States

TriWest Research Associates, LLC

San Diego, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

M&M Medical Center

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Orlando, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Precision Clinical Research,LLC

Sunrise, Florida, United States

Conquest Research

Winter Park, Florida, United States

Drug Studies America

Marietta, Georgia, United States

Health Research Network II, LLC

Flossmoor, Illinois, United States

Affinity Health Corp.

Oak Brook, Illinois, United States

Medisphere Medical Research Center, LLC

Evansville, Indiana, United States

Velocity Clinical Research-Boise

Meridian Hills, Indiana, United States

AMR Wichita West

Wichita, Kansas, United States

Alliance for Multispecialty Research, LLC.

Lexington, Kentucky, United States

Bay State Clinical Trials

Watertown, Massachusetts, United States

Healthcare Research Network, Inc.

Hazelwood, Missouri, United States

AMR Las Vegas

Las Vegas, Nevada, United States

Drug Trials America, Inc.

Hartsdale, New York, United States

Upstate Clinical Research Associates, LLC

Williamsville, New York, United States

Hightop Medical Research Center

Cincinnati, Ohio, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Future Search Trials

Austin, Texas, United States

Clinical Investigations of Texas,LLC

Plano, Texas, United States

Spectrum Medical, Inc.

Danville, Virginia, United States

Health Research of Hampton Roads

Newport News, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ACP-044-005

Identifier Type: -

Identifier Source: org_study_id