Fibromyalgia
Conditions
Brief summary
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
Detailed description
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia. This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week double-blind, randomized, placebo-controlled Treatment Period.
Interventions
DRUGNYX-2925
NYX-2925 administered orally
DRUGPlacebo
Placebo administered orally
Sponsors
Worldwide Clinical Trials
Aptinyx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Subject has a history of fibromyalgia that was diagnosed \>1 year prior to screening and reports at least moderate pain over the last week * Stable protocol allowed medication and other therapies during the study * Agrees to use highly effective birth control during the study * Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study
Exclusion criteria
* Pain due to other conditions or diseases that would complicate participation in the study or pain reporting * Current or historical serious medical conditions * Prior participation in NYX-2925 clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Numerical Rating Scale (NRS) Score | Week 12 | Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Sleep Interference (DSIS) Score | Week 12 | Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep. |
| Number of Subjects Achieving ≥30% Pain Reduction | Week 12 | Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain). |
| Number of Subjects Achieving ≥50% Pain Reduction | Week 12 | Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain) |
| Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | Week 12 | Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia |
| Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | Week 12 | Number of subjects much improved or very much improved on the Patient Global Impression of Change (PGI-C) at Week 12 |
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | Week 12 | Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue |
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | Week 12 | Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function. |
| Use of Rescue Medication | Week 12 | The number of subjects using rescue medication. |
| Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | Week 12 | Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NYX-2925 50 mg NYX-2925 50 mg administered orally once daily. | 101 |
| NYX-2925 100 mg NYX-2925 100 mg administered orally once daily. | 104 |
| Placebo Placebo administered orally once daily. | 105 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 | 6 |
| Overall Study | Lack of Efficacy | 3 | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 6 | 2 |
| Overall Study | Subject Noncompliance, Other | 4 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 10 |
Baseline characteristics
| Characteristic | Placebo | Total | NYX-2925 50 mg | NYX-2925 100 mg |
|---|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 12.28 | 52.7 years STANDARD_DEVIATION 12.83 | 53.1 years STANDARD_DEVIATION 12.81 | 51.8 years STANDARD_DEVIATION 13.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 82 Participants | 33 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 227 Participants | 67 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 34 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 84 Participants | 259 Participants | 87 Participants | 88 Participants |
| Region of Enrollment United States | 105 participants | 310 participants | 101 participants | 104 participants |
| Sex: Female, Male Female | 96 Participants | 289 Participants | 94 Participants | 99 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 104 | 0 / 105 |
| other Total, other adverse events | 18 / 101 | 19 / 104 | 18 / 105 |
| serious Total, serious adverse events | 0 / 101 | 2 / 104 | 0 / 105 |
Outcome results
Primary
Change in the Mean Numerical Rating Scale (NRS) Score
Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NYX-2925 50 mg | Change in the Mean Numerical Rating Scale (NRS) Score | -1.26 units on a scale | Standard Deviation 1.603 |
| NYX-2925 100 mg | Change in the Mean Numerical Rating Scale (NRS) Score | -1.47 units on a scale | Standard Deviation 1.983 |
| Placebo | Change in the Mean Numerical Rating Scale (NRS) Score | -1.23 units on a scale | Standard Deviation 1.846 |
p-value: 0.539t-test, 2 sided
p-value: 0.425t-test, 2 sided
Secondary
Daily Sleep Interference (DSIS) Score
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NYX-2925 50 mg | Daily Sleep Interference (DSIS) Score | -1.42 units on a scale | Standard Deviation 1.835 |
| NYX-2925 100 mg | Daily Sleep Interference (DSIS) Score | -1.45 units on a scale | Standard Deviation 2.104 |
| Placebo | Daily Sleep Interference (DSIS) Score | -1.38 units on a scale | Standard Deviation 2.177 |
p-value: 0.297t-test, 2 sided
p-value: 0.603t-test, 2 sided
Secondary
Fibromyalgia Impact Questionnaire-Revised (FIQR) Score
Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NYX-2925 50 mg | Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | -12.6 units on a scale | Standard Deviation 20.1 |
| NYX-2925 100 mg | Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | -12.3 units on a scale | Standard Deviation 20.56 |
| Placebo | Fibromyalgia Impact Questionnaire-Revised (FIQR) Score | -9.9 units on a scale | Standard Deviation 20.08 |
p-value: 0.059t-test, 2 sided
p-value: 0.726t-test, 2 sided
Secondary
Number of Subjects Achieving ≥30% Pain Reduction
Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain).
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NYX-2925 50 mg | Number of Subjects Achieving ≥30% Pain Reduction | 30 Participants |
| NYX-2925 100 mg | Number of Subjects Achieving ≥30% Pain Reduction | 34 Participants |
| Placebo | Number of Subjects Achieving ≥30% Pain Reduction | 29 Participants |
p-value: 0.871t-test, 2 sided
p-value: 0.352t-test, 2 sided
Secondary
Number of Subjects Achieving ≥50% Pain Reduction
Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NYX-2925 50 mg | Number of Subjects Achieving ≥50% Pain Reduction | 13 Participants |
| NYX-2925 100 mg | Number of Subjects Achieving ≥50% Pain Reduction | 15 Participants |
| Placebo | Number of Subjects Achieving ≥50% Pain Reduction | 13 Participants |
p-value: 1t-test, 2 sided
p-value: 0.626t-test, 2 sided
Secondary
Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12
Number of subjects much improved or very much improved on the Patient Global Impression of Change (PGI-C) at Week 12
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NYX-2925 50 mg | Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | 22 Participants |
| NYX-2925 100 mg | Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | 24 Participants |
| Placebo | Number of Subjects Much Improved or Very Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12 | 24 Participants |
p-value: 0.824t-test, 2 sided
p-value: 1t-test, 2 sided
Secondary
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score
Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NYX-2925 50 mg | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | -3.5 units on a scale | Standard Deviation 8.7 |
| NYX-2925 100 mg | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | -3.7 units on a scale | Standard Deviation 9.04 |
| Placebo | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score | -2.9 units on a scale | Standard Deviation 7.9 |
p-value: 0.536t-test, 2 sided
p-value: 0.982t-test, 2 sided
Secondary
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score
Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NYX-2925 50 mg | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | 2.18 units on a scale | Standard Deviation 5.017 |
| NYX-2925 100 mg | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | 2.08 units on a scale | Standard Deviation 5.223 |
| Placebo | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score | 1.83 units on a scale | Standard Deviation 5.153 |
p-value: 0.19t-test, 2 sided
p-value: 0.764t-test, 2 sided
Secondary
Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score
Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NYX-2925 50 mg | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | -3.59 units on a scale | Standard Deviation 8.238 |
| NYX-2925 100 mg | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | -3.93 units on a scale | Standard Deviation 8.346 |
| Placebo | Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score | -4.66 units on a scale | Standard Deviation 9.567 |
p-value: 0.888t-test, 2 sided
p-value: 0.832t-test, 2 sided
Secondary
Use of Rescue Medication
The number of subjects using rescue medication.
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NYX-2925 50 mg | Use of Rescue Medication | 93 Participants |
| NYX-2925 100 mg | Use of Rescue Medication | 87 Participants |
| Placebo | Use of Rescue Medication | 88 Participants |
p-value: 0.097t-test, 2 sided
p-value: 0.849t-test, 2 sided