Trial Outcomes & Findings for Evaluate the Efficacy and Safety of ACP-044 in Subjects With Pain Associated With Osteoarthritis of the Knee (NCT NCT05008835)

Last Updated: 2025-01-09

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-01-09

Participant Flow

During the screening period of up to 4 weeks, patients were assessed for eligibility. Prohibited medication was to be discontinued. Eligible patients had to complete a Baseline Pain Assessment Period of about 7 days before randomization (allowed time window +3 days) to be instructed in the use of an electronic diary and to record pain scores and rescue medication use. Compliance with data recording was assessed for continued eligibility. Upon completion of this period, patients were randomised.

Participant milestones

Participant milestones
Measure	Placebo Administration of ACP-044 matching placebo 4 times daily (morning, noon, evening, night)	ACP-044 400 mg QID Administration 4 times daily (morning, noon, evening, night) of 400 mg ACP-044 At each the morning and evening administration, patients received one placebo tablet and one tablet containing ACP-044 400 mg. At each the noon and night administration, patients received one tablet containing ACP-044 400 mg.	ACP-044 800 mg BID Administration 2 times daily (morning, noon, evening, night) of 800 mg ACP-044 At each the morning and evening administration, patients received 2 tablets containing ACP-044 400 mg. At each the noon and night administration, patients received one placebo tablet.
Overall Study STARTED	21	20	20
Overall Study COMPLETED	13	16	16
Overall Study NOT COMPLETED	8	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Administration of ACP-044 matching placebo 4 times daily (morning, noon, evening, night)	ACP-044 400 mg QID Administration 4 times daily (morning, noon, evening, night) of 400 mg ACP-044 At each the morning and evening administration, patients received one placebo tablet and one tablet containing ACP-044 400 mg. At each the noon and night administration, patients received one tablet containing ACP-044 400 mg.	ACP-044 800 mg BID Administration 2 times daily (morning, noon, evening, night) of 800 mg ACP-044 At each the morning and evening administration, patients received 2 tablets containing ACP-044 400 mg. At each the noon and night administration, patients received one placebo tablet.
Overall Study Adverse Event	5	2	1
Overall Study Lack of Efficacy	0	0	1
Overall Study Study terminated by sponsor	0	0	1
Overall Study Not further specified	3	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=21 Participants Administration of ACP-044 matching placebo 4 times daily (morning, noon, evening, night)	ACP-044 400 mg QID n=20 Participants Administration 4 times daily (morning, noon, evening, night) of 400 mg ACP-044 At each the morning and evening administration, patients received one placebo tablet and one tablet containing ACP-044 400 mg. At each the noon and night administration, patients received one tablet containing ACP-044 400 mg.	ACP-044 800 mg BID n=20 Participants Administration 2 times daily (morning, noon, evening, night) of 800 mg ACP-044 At each the morning and evening administration, patients received 2 tablets containing ACP-044 400 mg. At each the noon and night administration, patients received one placebo tablet.	Total n=61 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 5.02 • n=5 Participants	58.1 years STANDARD_DEVIATION 4.82 • n=7 Participants	56.8 years STANDARD_DEVIATION 5.31 • n=5 Participants	57.2 years STANDARD_DEVIATION 5.01 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	61 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: All patients randomised and treated.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Administration of ACP-044 matching placebo 4 times daily (morning, noon, evening, night)	ACP-044 400 mg QID n=20 Participants Administration 4 times daily (morning, noon, evening, night) of 400 mg ACP-044 At each the morning and evening administration, patients received one placebo tablet and one tablet containing ACP-044 400 mg. At each the noon and night administration, patients received one tablet containing ACP-044 400 mg.	ACP-044 800 mg BID n=20 Participants Administration 2 times daily (morning, noon, evening, night) of 800 mg ACP-044 At each the morning and evening administration, patients received 2 tablets containing ACP-044 400 mg. At each the noon and night administration, patients received one placebo tablet.
Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores Baseline	5.4 score on a scale Standard Deviation 1.81	6.1 score on a scale Standard Deviation 1.12	5.6 score on a scale Standard Deviation 1.64
Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores Week 1	3.1 score on a scale Standard Deviation 1.81	4.4 score on a scale Standard Deviation 2.24	4.6 score on a scale Standard Deviation 1.63
Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores Week 2	3.0 score on a scale Standard Deviation 1.28	3.9 score on a scale Standard Deviation 2.26	4.2 score on a scale Standard Deviation 2.19
Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores Week 3	2.9 score on a scale Standard Deviation 0.88	3.8 score on a scale Standard Deviation 2.36	4.2 score on a scale Standard Deviation 2.33
Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Intensity Scores Week 4	—	4.0 score on a scale Standard Deviation 1.41	3.0 score on a scale Standard Deviation NA Standard deviation not applicable if only a single patient is included in the assessment.

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACP-044 400 mg QID

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ACP-044 800 mg BID

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=21 participants at risk Administration of ACP-044 matching placebo 4 times daily (morning, noon, evening, night)	ACP-044 400 mg QID n=20 participants at risk Administration 4 times daily (morning, noon, evening, night) of 400 mg ACP-044 At each the morning and evening administration, patients received one placebo tablet and one tablet containing ACP-044 400 mg. At each the noon and night administration, patients received one tablet containing ACP-044 400 mg.	ACP-044 800 mg BID n=20 participants at risk Administration 2 times daily (morning, noon, evening, night) of 800 mg ACP-044 At each the morning and evening administration, patients received 2 tablets containing ACP-044 400 mg. At each the noon and night administration, patients received one placebo tablet.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/21 • 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.	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/20 • 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • 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.	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/20 • 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.
General disorders Fatigue	0.00% 0/21 • 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.	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/20 • 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.
General disorders Pyrexia	0.00% 0/21 • 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.	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/20 • 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.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/21 • 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.	0.00% 0/20 • 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.	5.0% 1/20 • Number of events 1 • 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.
Investigations Gamma-glutamyltransferase increased	0.00% 0/21 • 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.	0.00% 0/20 • 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.	5.0% 1/20 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/21 • 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.	0.00% 0/20 • 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.	5.0% 1/20 • Number of events 1 • 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.
Nervous system disorders Cervical radiculopathy	0.00% 0/21 • 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.	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/20 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/21 • 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.	10.0% 2/20 • Number of events 2 • 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.	5.0% 1/20 • Number of events 1 • 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.

Additional Information

Sr. Dir. Medical Information and Medical Communications

Acadia Pharmaceuticals Inc.

Phone: 858-261

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator may publish the study results, relative to their own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the Sponsor for review and comment. The sponsor has 60 days to review and comment.
Publication restrictions are in place

Restriction type: OTHER