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

NCT05008835 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ACP-044-005
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 34

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

Outcome Measures

Primary Outcomes (1)

• Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores

  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.

  4 weeks

Study Arms (3)

Drug - ACP-044 Dose A

EXPERIMENTAL

ACP-044 Dose A

Drug: ACP-044 Dose A

Drug - ACP-044 Dose B

EXPERIMENTAL

ACP-044 Dose B

Drug: ACP-044 Dose B

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ACP-044 Dose A DRUG

Oral dose of ACP-044 Dose A

Drug - ACP-044 Dose A

ACP-044 Dose B DRUG

Oral dose of ACP-044 Dose B

Drug - ACP-044 Dose B

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (34)

Clinical Research Investment, LLC

Birmingham, Alabama, 35216, United States

Location

AOC-Research

Birmingham, Alabama, 36243, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Velocity Clinical Research, North Hollywood

North Hollywood, California, 91606, United States

Location

Artemis Headlands, LLC

San Diego, California, 92103, United States

Location

TriWest Research Associates, LLC

San Diego, California, 92108, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

M&M Medical Center

Miami, Florida, 33185, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Orlando, Florida, 32801, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Precision Clinical Research,LLC

Sunrise, Florida, 33351, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Health Research Network II, LLC

Flossmoor, Illinois, 60422, United States

Location

Affinity Health Corp.

Oak Brook, Illinois, 60523, United States

Location

Medisphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Velocity Clinical Research-Boise

Meridian Hills, Indiana, 83642, United States

Location

AMR Wichita West

Wichita, Kansas, 67205, United States

Location

Alliance for Multispecialty Research, LLC.

Lexington, Kentucky, 40509, United States

Location

Bay State Clinical Trials

Watertown, Massachusetts, 02472, United States

Location

Healthcare Research Network, Inc.

Hazelwood, Missouri, 63042, United States

Location

AMR Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Drug Trials America, Inc.

Hartsdale, New York, 10530, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Future Search Trials

Austin, Texas, 78731, United States

Location

Clinical Investigations of Texas,LLC

Plano, Texas, 75075, United States

Location

Spectrum Medical, Inc.

Danville, Virginia, 24541, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

Limitations and Caveats

Due to the business decision to discontinue clinical development of ACP-044, this study was prematurely terminated. Instead of a planned number of 240 patients, only 61 patients were randomised. Due to these facts, efficacy was not evaluated in this study.

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: Acadia Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: July 20, 2021
• Primary Completion: October 6, 2022
• Study Completion: November 16, 2022
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)