Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT03249103|
Recruitment Status : Completed
First Posted : August 15, 2017
Results First Posted : September 16, 2022
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: NYX-2925 Drug: Placebo oral capsule||Phase 2|
This is a single-blind, exploratory, placebo-controlled, pilot study to assess the efficacy and safety of daily oral NYX-2925 in fibromyalgia subjects. The study will include a screening period (up to 30 days), a placebo period, an active treatment period with, and a follow-up period as follows:
- Placebo PO Every Day (QD) for 2 weeks
- NYX-2925 PO QD for 2 weeks (2x)
- Follow-up for 1 week
Eligible subjects will receive MRIs during the screening period, during the placebo period, during the NYX-2925 PO QD period. Safety assessments will be conducted and adverse events will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected for exploratory analysis. During the follow-up period, an optional MRI will be completed for consenting subjects in order to evaluate duration of effect.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects will receive placebo, NYX-2925 20 mg QD, NYX-2925 200 mg QD for sequential 2 week treatment periods, then go into Follow-up for 1 week.|
|Masking:||None (Open Label)|
|Masking Description:||Subjects are masked to the sequence in which they are taking placebo QD, NYX-2925 20 mg QD, NYX-2925 200 mg QD.|
|Official Title:||A Phase 2, Single-Blind, Exploratory, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Daily Oral NYX-2925 in Subjects With Fibromyalgia|
|Actual Study Start Date :||August 14, 2017|
|Actual Primary Completion Date :||April 18, 2019|
|Actual Study Completion Date :||April 18, 2019|
Experimental: All subjects
Up to 24 subjects will receive placebo, NYX-2925 20 mg QD, and NYX-2925 200 mg QD for sequential 2 week treatment periods, then go into Follow-up for 1 week.
NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Drug: Placebo oral capsule
Matching placebo capsules.
- 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. [ Time Frame: Week 2, Week 4, Week 6 ]
- 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. [ Time Frame: Week 2, Week 4, and Week 6 ]
- Mean Change in Numeric Pain Rating Scale (NPRS) Score Assessing Average Pain in the Past 24 Hours [ Time Frame: Change from Baseline, Week 2 (Placebo), Week 4, and Week 6 (NYX-2925) ]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.
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): NCT03249103
|United States, Michigan|
|Aptinyx Clinical Site|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|Aptinyx Clinical Site|
|Cincinnati, Ohio, United States, 45220|