Trial Outcomes & Findings for Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia (NCT NCT03249103)

NCT ID: NCT03249103

Last Updated: 2022-09-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: Week 2, Week 4, Week 6
• Results posted on: 2022-09-16

Participant Flow

Approximately 24 subjects were planned to be enrolled. Twenty-two (22) subjects were enrolled.

Participant milestones

Measure	All Treated Subjects Subjects received Placebo, 20 mg NYX-2925 once daily (QD), and 200 mg NYX-2925 QD
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

Baseline characteristics by cohort

Measure	All Treated Subjects n=22 Participants Subjects received Placebo, 20 mg NYX-2925 QD, and 200 mg NYX-2925 QD
Age, Continuous	47.3 years STANDARD_DEVIATION 15.06 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Fibromyalgia disease history, years	14.57 years STANDARD_DEVIATION 14.476 • n=5 Participants

PRIMARY outcome

Timeframe: Week 2, Week 4, Week 6

Population: Population includes study subjects with analyzable images (n=20)

Outcome measures

Measure	All Treated Subjects n=20 Participants Subjects received Placebo, 20 mg NYX-2925 QD, and 200 mg NYX-2925 QD
Mean (SD) Glx/Total Creatine Levels in Dorsal Anterior Cingulate Cortex (dACC): NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. dACC mean placebo	2.1670 ratio Standard Deviation 0.17796
Mean (SD) Glx/Total Creatine Levels in Dorsal Anterior Cingulate Cortex (dACC): NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. dACC mean NYX-2925 20 mg	2.0550 ratio Standard Deviation 0.19710
Mean (SD) Glx/Total Creatine Levels in Dorsal Anterior Cingulate Cortex (dACC): NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. dACC NYX-2925 200 mg	2.0975 ratio Standard Deviation 0.19141

PRIMARY outcome

Timeframe: Week 2, Week 4, and Week 6

Population: Population includes study subjects with analyzable images (n=19)

Outcome measures

Measure	All Treated Subjects n=19 Participants Subjects received Placebo, 20 mg NYX-2925 QD, and 200 mg NYX-2925 QD
Mean (SD) Changes in Posterior Insula (pINS) Glx/Total Creatine Levels Before and After Acute Painful Pressure Stimulation: NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. pINS mean placebo	1.993 ratio Standard Deviation 0.13981
Mean (SD) Changes in Posterior Insula (pINS) Glx/Total Creatine Levels Before and After Acute Painful Pressure Stimulation: NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. pINS mean NYX-2925 20 mg	1.911 ratio Standard Deviation 0.14242
Mean (SD) Changes in Posterior Insula (pINS) Glx/Total Creatine Levels Before and After Acute Painful Pressure Stimulation: NYX-2925 20 mg and 200 mg PO QD at Week 4 and Week 6, Respectively. pINS NYX-2925 200 mg	1.903 ratio Standard Deviation 0.16194

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline, Week 2 (Placebo), Week 4, and Week 6 (NYX-2925)

Population: The efficacy population is based on subjects included in the safety population and have at least one post-baseline visit after receiving NYX-2925 20 mg PO QD.

Numeric pain rating scale is a unidimensional segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of their pain, where 0 represents no pain and 10 the worst pain imaginable.

Outcome measures

Measure	All Treated Subjects n=18 Participants Subjects received Placebo, 20 mg NYX-2925 QD, and 200 mg NYX-2925 QD
Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours Baseline	5.32 units on a scale Standard Deviation 1.411
Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours Week 2	4.82 units on a scale Standard Deviation 1.275
Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours Week 4	4.74 units on a scale Standard Deviation 1.360
Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours Week 6	4.12 units on a scale Standard Deviation 1.650

Adverse Events

All Treated Subjects

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Treated Subjects n=22 participants at risk Subjects received Placebo, 20 mg NYX-2925 QD, and 200 mg NYX-2925 QD. Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Gastrointestinal disorders Abdominal distension	13.6% 3/22 • Number of events 3 • Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7). Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Psychiatric disorders Anxiety	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7). Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Gastrointestinal disorders Diarrhoea/	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7). Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Gastrointestinal disorders Eructation	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7). Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Nervous system disorders Tension headache	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7). Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Infections and infestations Viral upper respiratory tract infection	9.1% 2/22 • Number of events 2 • Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7). Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.

Additional Information

Aptinyx Clinical Development

Aptinyx

Phone: 847-871-0377

Email: clinicalstudies@aptinyx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place