Trial record 2 of 5 for:
NYX-2925
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04146896 |
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Recruitment Status :
Active, not recruiting
First Posted : October 31, 2019
Last Update Posted : October 28, 2021
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Sponsor:
Aptinyx
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Aptinyx
- Study Details
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Brief Summary:
To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Peripheral Neuropathic Pain | Drug: NYX-2925 50 mg Drug: Placebo | Phase 2 |
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy.
The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 229 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Subjects will be randomized to receive either placebo or NYX-2925. |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Randomization algorithm, randomization allocation, allocation to study drug or placebo. |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy |
| Actual Study Start Date : | November 12, 2019 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | June 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Peripheral Nerve Disorders
| Arm | Intervention/treatment |
|---|---|
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Experimental: NYX-2925
NYX-2925 50 mg
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Drug: NYX-2925 50 mg
NYX-2925 administered orally |
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
Placebo administered orally |
Primary Outcome Measures :
- Numeric Rating Scale (NRS) score [ Time Frame: Week 12 ]Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.
Secondary Outcome Measures :
- Daily Sleep Interference Scale (DSIS) score [ Time Frame: Week 12 ]Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores. The DSIS asks participants to ''Select the number that best describes how much your pain has interfered with your sleep during the past 24 hours.'' Response options for the DSIS range from 0 (did not interfere with sleep) to 10 (completely interfered with sleep/unable to sleep due to pain).
- Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 ]Percentage of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)
- Percentage of subjects achieving ≥30% pain reduction [ Time Frame: Week 12 ]Percentage of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN
- Percentage of subjects achieving ≥50% reduction [ Time Frame: Week 12 ]Percentage of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN
- Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score [ Time Frame: Week 12 ]Change from baseline in the Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score. The QOL-DN is a 47 item subject reported questionnaire, in which lower scores indicate improved quality of life.
- 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
- Cumulative response (percent reduction from baseline) [ Time Frame: Week 12 ]Cumulative response (percent reduction from baseline) in the weekly mean NRS average pain intensity at Week 12
- Change from baseline in mean NRS 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Informed consent
- Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for ≥4 years and reports at least moderate pain over the last week
- Stable diabetic and protocol allowed medication 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146896
Locations
| United States, California | |
| Aptinyx Clinical Site | |
| Fresno, California, United States, 93720 | |
| Aptinyx Clinical Site | |
| Irvine, California, United States, 92612 | |
| Aptinyx Clinical Site | |
| Lomita, California, United States, 90717 | |
| Aptinyx Clinical Site | |
| Los Angeles, California, United States, 90048 | |
| Aptinyx Clinical Site | |
| Norco, California, United States, 92860 | |
| Aptinyx Clinical Site | |
| Pomona, California, United States, 91767 | |
| Aptinyx Clinical Site | |
| Santa Ana, California, United States, 92705 | |
| Aptinyx Clinical Site | |
| Tustin, California, United States, 92780 | |
| United States, Florida | |
| Aptinyx Clinical Site | |
| Brandon, Florida, United States, 33511 | |
| Aptinyx Clinical Site | |
| Clearwater, Florida, United States, 33765 | |
| Aptinyx Clinical Site | |
| Greenacres City, Florida, United States, 33467 | |
| Aptinyx Clinical Site | |
| Miami, Florida, United States, 33126 | |
| Aptinyx Clinical Site | |
| Miami, Florida, United States, 33144 | |
| Aptinyx Clinical Site | |
| New Port Richey, Florida, United States, 34655 | |
| Aptinyx Clinical Site | |
| Tampa, Florida, United States, 33615 | |
| Aptinyx Clinical Site | |
| Tampa, Florida, United States, 33634 | |
| Aptinyx Clinical Site | |
| Winter Haven, Florida, United States, 33880 | |
| Aptinyx Clinical Site | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Aptinyx Clinical Site | |
| Decatur, Georgia, United States, 30030 | |
| Aptinyx Clinical Site | |
| Marietta, Georgia, United States, 30060 | |
| United States, Idaho | |
| Aptinyx Clinical Site | |
| Blackfoot, Idaho, United States, 83221 | |
| United States, Illinois | |
| Aptinyx Clinical Site | |
| Flossmoor, Illinois, United States, 60422 | |
| United States, Michigan | |
| Aptinyx Clinical Site | |
| Rochester, Michigan, United States, 48307 | |
| United States, Missouri | |
| Aptinyx Clinical Site | |
| Hazelwood, Missouri, United States, 63042 | |
| United States, Nevada | |
| Aptinyx Clinical Site | |
| Las Vegas, Nevada, United States, 89123 | |
| United States, New York | |
| Aptinyx Clinical Site | |
| Brooklyn, New York, United States, 11235 | |
| Aptinyx Clinical Site | |
| New York, New York, United States, 10036 | |
| Aptinyx Clinical Site | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Aptinyx Clinical Site | |
| Greenville, North Carolina, United States, 27834 | |
| Aptinyx Clinical Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Pennsylvania | |
| Aptinyx Clinical Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Texas | |
| Aptinyx Clinical Site | |
| Houston, Texas, United States, 77030 | |
| Aptinyx Clinical Site | |
| Mesquite, Texas, United States, 75149 | |
| Aptinyx Clinical Site | |
| Plano, Texas, United States, 75024 | |
| Aptinyx Clinical Site | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Aptinyx
Worldwide Clinical Trials
| Responsible Party: | Aptinyx |
| ClinicalTrials.gov Identifier: | NCT04146896 |
| Other Study ID Numbers: |
NYX-2925-2008 |
| First Posted: | October 31, 2019 Key Record Dates |
| Last Update Posted: | October 28, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Pain Neurologic Manifestations |