Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia

• ClinicalTrials.gov Identifier: NCT04147858
• Recruitment Status: Active, not recruiting
• First Posted: November 1, 2019
• Last Update Posted: March 15, 2022
• Sponsor: Aptinyx
• Collaborator: Worldwide Clinical Trials
• Information provided by (Responsible Party): Aptinyx

Tracking Information

• First Submitted Date: October 29, 2019
• First Posted Date: November 1, 2019
• Last Update Posted Date: March 15, 2022
• Actual Study Start Date: November 12, 2019
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 28, 2020)

Change in the mean Numerical Rating Scale (NRS) score [ Time Frame: 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

Original Primary Outcome Measures (submitted: October 30, 2019)

Change in the mean NRS score [ Time Frame: Up to Week 14 ]

Change in the mean NRS score assessing average pain intensity in the past 24 hours from baseline

Current Secondary Outcome Measures (submitted: March 29, 2021)

• Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 ]
  Percentage of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12
• Daily Sleep Interference (DSIS) score [ Time Frame: Week 12 ]
  Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12
• Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Week 12 ]
  Percentage of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12
• Percentage of subjects achieving ≥50% pain reduction [ Time Frame: Week 12 ]
  Percentage of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12
• Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Week 12 ]
  Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score
• Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) sleep disturbance score [ Time Frame: Week 12 ]
  Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score
• Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) fatigue profile score [ Time Frame: Week 12 ]
  Change from baseline to Week 12 in the PROMIS-FM fatigue profile score
• Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) physical function score [ Time Frame: Week 12 ]
  Change from baseline to Week 12 in the PROMIS-FM physical function score
• Cumulative response (percent reduction from baseline) in weekly mean NRS [ Time Frame: Week 12 ]
  Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12
• Use of rescue medication [ Time Frame: Week 12 ]
  Use of rescue medication, including the proportion of subjects using rescue medication, the frequency and amount used
• Change in the mean NRS score at each week [ Time Frame: Week 1 - Week 12 ]
  Change from baseline in the weekly mean of the daily Numerical Rating Scale (NRS) at each week from Week 1 through Week 12

Original Secondary Outcome Measures (submitted: October 30, 2019)

• Daily Sleep Interference (DSIS) score [ Time Frame: Up to Week 14 ]
  Change from baseline in the mean Daily Sleep Interference (DSIS) score
• Patient Global Impression of Change (PGI-C) [ Time Frame: Up to Week 14 ]
  Patient Global Impression of Change (PGI-C)
• Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Up to Week 14 ]
  Percentage of subjects achieving ≥30% pain reduction in the mean NRS average pain intensity from baseline
• Fibromyalgia Impact Questionnaire-Revised (FIQR) score [ Time Frame: Up to Week 14 ]
  Change from baseline in the Fibromyalgia Impact Questionnaire-Revised (FIQR) score
• Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) score [ Time Frame: Up to Week 14 ]
  Change from baseline in the Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) score
• Patient Reported Outcomes Measurement Information System - Firbomyalgia (PROMIS-FM) [ Time Frame: Up to Week 14 ]
  Change from baseline in the Patient Reported Outcomes Measurement Information System - Firbomyalgia (PROMIS-FM)

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: October 30, 2019)

Other Endpoints [ Time Frame: Up to Week 14 ]

Adverse Events

Descriptive Information

• Brief Title: Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
• Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
• 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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Randomization algorithm, randomization allocation, allocation to study drug or placebo.

Primary Purpose: Treatment

• Condition: Fibromyalgia

Intervention

• Drug: NYX-2925
  NYX-2925 administered orally
• Drug: Placebo
  Placebo administered orally

Study Arms

• Experimental: NYX-2925 50 mg
  NYX-2925 50 mg administered orally.
  Intervention: Drug: NYX-2925
• Experimental: NYX-2925 100 mg
  NYX-2925 100 mg administered orally.
  Intervention: Drug: NYX-2925
• Placebo Comparator: Placebo
  Placebo administered orally.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 14, 2022): 305
• Original Estimated Enrollment (submitted: October 30, 2019): 300
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04147858
• Other Study ID Numbers: NYX-2925-2005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Aptinyx
• Study Sponsor: Aptinyx
• Collaborators: Worldwide Clinical Trials
• Investigators: Not Provided
• PRS Account: Aptinyx
• Verification Date: March 2022