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Randomized Controlled Trial
. 2024 Dec 1;165(12):2762-2773.
doi: 10.1097/j.pain.0000000000003287. Epub 2024 Jun 14.

A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain

Alan Miller  1 , Kenneth D Candido  2 , Nebojsa Nick Knezevic  2 , José Rivera  3 , Paul Lunseth  4 , Dennis J Levinson  5 , Ferdinand Formoso  6 , Daneshvari Solanki  7 , Edward Tavel  8 , Angela Krull  9 , Richard Radnovich  10 , Daniel Burkhead  11 , Dmitri Souza  12 , Standiford Helm  13 , Nathaniel Katz  14 , Robert H Dworkin  15 , Steven P Cohen  16 , James P Rathmell  17 , Asokumar Buvanendran  18 , Joshua Levin  19 , Elizabeth Stannard  20 , Chris Ambrose  21 , Mark Jaros  22 , Kip Vought  20 , Dmitri Lissin  21
Affiliations
Randomized Controlled Trial

A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain

Alan Miller et al. Pain. .

Abstract

ClinicalTrials.gov Identifier: NCT03372161.

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Conflict of interest statement

Dr. Miller A.M. reported serving as a consultant for Scilex Holding Company. K.D.C. reported receiving payments for expert testimony. N.N.K. reported serving as a consultant for Scilex Holding Company, Tris Pharma, and Esai Inc. D.S. reported serving on the Speaker Bureau for AbbVie and serving as a consultant for Scilex Holding Company. S.H. reported receiving payments for expert testimony. N.K. was a paid consultant for Scilex Holding Company and his employer at the time of the study, WCG (www.wcgclinical.com) provided supportive services for the CLEAR Trial. R.H.D. has received research grants and contracts from the US FDA and the US National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, Beckley, Biogen, Biohaven, Biosplice, Boston Scientific, Braeburn, Cardialen, Centrexion, Chiesi, Chromocell, Clexio, Collegium, CoimbiGene, Confo, Decibel, Editas, Eli Lilly, Endo, Ethismos (equity), Eupraxia, Exicure, GlaxoSmithKline, Glenmark, Gloriana, Hope, Juca, Kriya, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, Orion, OliPass, Oxford, Cannabinoid Technologies, Pfizer, Q-State, Reckitt Benckiser, Regenacy (also equity), Rho, Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Biopharmaceuticals, Sollis, SPRIM, Teva, Theranexus, Vertex, Vizuri, and WCG. S.P.C. reported receiving research funding to his institution and serving as a consultant for Scilex Holding Company and Avanos. He also reported serving as a consultant for SPR Therapeutics, CLEARING, Persica, SWORD, Releviate (inactive), and CLEARING (inactive). He has also received payments for expert testimony. J.P.R. reported receiving NIH grant funding for NIH 1U24NS113850-01; he has also received payment for serving as Chair of the Clinical Events Committee for the ReActivat B international clinical trial for Mainstay, LLC, and other financial interests as Chief, Enterprise Anesthesiology, Mass General Brigham. D.J.L. reported serving as a consultant for Scilex Holding Company. E.S., K.V., and M.J. were paid consultants for Scilex Holding Company during the CLEAR Trial. C.A. and D.L. were employees of Scilex Holding Company. The remaining authors have no conflicts of interest to declare.

The data that support the findings of this study are available from the corresponding author (D.L.), upon reasonable request.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Figures

Figure 1.
Figure 1.
Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy trial schema.
Figure 2.
Figure 2.
Consort diagram primary analysis period (week 4).
Figure 3.
Figure 3.
Subjects receiving repeat SP-102 injection.
Figure 4.
Figure 4.
Mean NPRS average pain score (SE) in the affected leg over time in the ITT population. SP-102 vs placebo weeks 1-4: P = 0.002, 0.005, 0.003, 0.003. Overall treatment effect (mean SP-102 vs placebo difference): diff = −0.52, SE = 0.163, P = 0.002. Error bars: 95% confidence limits. ITT, intent-to-treat; LS mean: least squares means; NPRS, Numeric Pain Rating Scale.
Figure 5.
Figure 5.
Summary of patient global impression of change (PGIC) responses at week 4—ITT Population. N: SP-102 = 202, placebo = 199. PGIC, Patient Global Impression of Change; ITT, intent-to-treat.
Figure 6.
Figure 6.
Summary of CGIC responses at week 4—ITT Population. N: SP-102 = 202, placebo = 199. ITT, intent-to-treat; CGIC, Clinical Global Impression of Change.
Figure 7.
Figure 7.
Cumulative proportion of responders analysis graph of reduction from baseline in mean NPRS average pain score in the affected leg at week 4—ITT population. ITT, intent-to-treat; NPRS, Numeric Pain Rating Scale.
Figure 8.
Figure 8.
Survival plot of time (days) to repeat injection—ITT population. Censored subjects are the following: (1) subjects who do not receive a repeat injection of SP-102 and (2) subjects who discontinued the study before week 20 without receiving a repeat injection. ITT, intent-to-treat.
See this image and copyright information in PMC

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