Phase 2
Completed N=209
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Central Neuropathic Pain · Multiple Sclerosis
Source: ClinicalTrials.gov NCT01324232 ↗
Enrolled (actual)
209
Serious AEs
2.4%
Results posted
Nov 2021
Primary outcomePrimary: Association Between the Dextromethorphan Plasma Concentration and the Change From Baseline Pain Rating Scale (PRS) Score to the Average Pain Rating Scale Score During Days 57 Through 84 — -1.821; -2.143; -2.650; -1.679 units on a scale — p== 0.9827
Summary
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association Between the Dextromethorphan Plasma Concentration and the Change From Baseline Pain Rating Scale (PRS) Score to the Average Pain Rating Scale Score During Days 57 Through 84 |
-1.821; -2.143; -2.650; -1.679; -2.000 | = 0.9827 |
| PRIMARY Average Logarithms of Dextromethorphan (DM) Plasma Concentrations (Cmax) on Days 22 and 50 |
4.019; 4.493; 4.758; 4.394 | — |
| SECONDARY Comparison of the Adjusted Mean Change From Baseline PRS Score to the Average PRS Score During Days 57 Through 84 |
-2.04; -2.07; -2.41; -2.00; -2.24; -2.21 | =0.8869 |
| SECONDARY Mean Change From Baseline in Fatigue Severity Scale (FSS) Scores at Days 57 Through 84 |
-3.32; -2.00; -6.32; -2.12 | =0.9731 |
| SECONDARY Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Days 22 and 85 |
-0.1; -0.1; -0.2; -0.0; -0.1; -0.1 | — |
| SECONDARY Mean Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Scores at Day 85 |
-4.84; -4.34; -6.50; -1.41 | =0.4778 |
| SECONDARY Mean Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at Day 85 |
-0.51; -1.02; -1.36; -1.71 | =0.0685 |
| SECONDARY Mean Change From Baseline in MS Neuropsychological Screening Questionnaire (MSNQ) Scores at Day 85 |
-0.99; -1.48; -1.88; 0.47 | =0.4201 |
| SECONDARY Mean Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Day 85 |
0.83; -0.26; 0.21; 1.15 | =0.8068 |
| SECONDARY Mean Change From Baseline in Symbol Digit Modalities Test (SDMT) Scores at Day 85 |
0.59; 2.96; 1.91; 2.06; 1.85; 3.62 | =0.6315 |
| SECONDARY Mean Numerical Rating Scale (NRS) Scores at Days 22, 50, and 85 |
3.29; 3.56; 3.41; 3.90; 3.54; 3.24 | =0.1404 |
| SECONDARY Mean Overall Patient Global Impression of Change (PGIC) Scores at Day 85 |
3.58; 4.42; 3.70; 3.64; 3.84 | =0.9207 |
Eligibility Criteria
Main Inclusion Criteria:
Multiple Sclerosis (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS]), Clinical history and symptoms of central neuropathic pain (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (PRS) baseline score = or > 4, No MS relapse within previous 30 days.
Main Exclusion Criteria:
Personal history of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes, family history of congenital QT interval prolongation syndrome, Myasthenia Gravis, Beck Depression Inventory Second Edition (BDI-II) score > 19
Data sourced from ClinicalTrials.gov (NCT01324232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.