Osteoarthritis PainPhase 2NCT05008835

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

A Phase 2 study testing ACP-044 Dose A and ACP-044 Dose B in people with Osteoarthritis Pain, run by ACADIA Pharmaceuticals Inc. at 34 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the efficacy of ACP-044 compared with placebo in the treatment of pain associated with osteoarthritis of the knee Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Osteoarthritis Pain
What is being tested?: ACP-044 Dose A and ACP-044 Dose B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 34 sitesUnited States
Study dates: 20 Jul 2021to 16 Nov 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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)

Who cannot join

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

Show all 14Show fewer

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).

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Future Search Trials
Austin, Texas, 78731
Clinical Research Investment, LLC
Birmingham, Alabama, 35216
AOC-Research
Birmingham, Alabama, 36243
Hightop Medical Research Center
Cincinnati, Ohio, 45224
Spectrum Medical, Inc.
Danville, Virginia, 24541
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714
Health Research Network II, LLC
Flossmoor, Illinois, 60422
Drug Trials America, Inc.
Hartsdale, New York, 10530
Healthcare Research Network, Inc.
Hazelwood, Missouri, 63042
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
BioSolutions Clinical Research Center
La Mesa, California, 91942
AMR Las Vegas
Las Vegas, Nevada, 89119
Alliance for Multispecialty Research, LLC.
Lexington, Kentucky, 40509
Drug Studies America
Marietta, Georgia, 30060
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Velocity Clinical Research-Boise
Meridian Hills, Indiana, 83642
M&M Medical Center
Miami, Florida, 33185
Health Research of Hampton Roads
Newport News, Virginia, 23606
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606
Affinity Health Corp.
Oak Brook, Illinois, 60523
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Orlando, Florida, 32801
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Arizona Research Center
Phoenix, Arizona, 85053
Clinical Investigations of Texas,LLC
Plano, Texas, 75075
Artemis Headlands, LLC
San Diego, California, 92103
TriWest Research Associates, LLC
San Diego, California, 92108
Encompass Clinical Research
Spring Valley, California, 91978
Precision Clinical Research,LLC
Sunrise, Florida, 33351
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Bay State Clinical Trials
Watertown, Massachusetts, 02472
AMR Wichita West
Wichita, Kansas, 67205
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
Conquest Research
Winter Park, Florida, 32789

Other trials in United States

About this study

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

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

Conditions: Osteoarthritis Pain
Being tested: ACP-044 Dose A, ACP-044 Dose B, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACP-044 Dose ADrug
Oral dose of ACP-044 Dose A
ACP-044 Dose BDrug
Oral dose of ACP-044 Dose B
PlaceboDrug
Placebo

Study groups in NCT05008835
Study group	Role	What they receive
Drug - ACP-044 Dose A	Experimental	ACP-044 Dose A Receives: Drug: ACP-044 Dose A
Drug - ACP-044 Dose B	Experimental	ACP-044 Dose B Receives: Drug: ACP-044 Dose B
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202116 Nov 2022

First posted17 Aug 2021
Study start20 Jul 2021
Primary completion6 Oct 2022
Study completion16 Nov 2022

Why it stopped: Study was terminated for business reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05008835
Sponsor's protocol ID: ACP-044-005
Status last verified: Jan 2025
First submitted: 10 Aug 2021
Last updated: 9 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis

All Osteoarthritis Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05008835
Acronym / sponsor ID: ACP-044-005
Conditions: Osteoarthritis Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated for business reasons.
Enrolment: 61 participants (actual)
Lead sponsor: ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 20 Jul 2021 (actual)
Primary completion: 6 Oct 2022 (actual)
Study completion: 16 Nov 2022 (actual)
First posted: 17 Aug 2021 (actual)
Results: Posted 9 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Drug - ACP-044 Dose A	Experimental	Drug: ACP-044 Dose AACP-044 Dose A
Drug - ACP-044 Dose B	Experimental	Drug: ACP-044 Dose BACP-044 Dose B
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACP-044 Dose AOral dose of ACP-044 Dose A	Drug	Drug - ACP-044 Dose A
ACP-044 Dose BOral dose of ACP-044 Dose B	Drug	Drug - ACP-044 Dose B
PlaceboPlacebo	Drug	Placebo

Primary outcome

Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores
Time frame: 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.

Results and safety

Results posted to the registry on 9 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	21	13
ACP-044 400 mg QID	20	16
ACP-044 800 mg BID	20	16

Primary outcome: Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 21	ACP-044 400 mg QID n = 20	ACP-044 800 mg BID n = 20
Baseline	5.4 (1.81)	6.1 (1.12)	5.6 (1.64)
Week 1	3.1 (1.81)	4.4 (2.24)	4.6 (1.63)
Week 2	3.0 (1.28)	3.9 (2.26)	4.2 (2.19)
Week 3	2.9 (0.88)	3.8 (2.36)	4.2 (2.33)
Week 4	–	4.0 (1.41)	3.0 (NA)

Population analysed: All patients randomised and treated.

Adverse events

Time frame: AEs were planned to be reported from signing informed consent to the end of the follow-up period. Since the study was prematurely terminated, the AE reporting period was abbreviated and thus, AEs were assessed from signing the informed consent to the end of treatment, the mean (SD) duration of this period was 24.1 (8.2) days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	0 of 21 (0%)	0 of 21
ACP-044 400 mg QID	0 of 20 (0%)	4 of 20 (20%)	0 of 20
ACP-044 800 mg BID	0 of 20 (0%)	4 of 20 (20%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis Pain

RecruitingPhase 3
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Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACP-044 Dose A and ACP-044 Dose B in people with Osteoarthritis Pain, run by ACADIA Pharmaceuticals Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05008835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.