Research
Research
The Center is actively pursuing research in the field of Neuromodulation, in particular SCS for failed back surgery syndrome and other neuropathies. In addition, patients benefit from access to leading edge research and clinical trials:
1. Relevant Study
Prospective, Randomized Study of Multi-column Implantable Lead Stimulation for Predominant Low Back Pain (PROMISE).
Subjects will be randomized 1:1 RF ablation arm vs Control arm; this is an open-label trial. Subjects in the RF ablation arm will receive the Intracept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic type 1 or 2 changes. Subjects in the Control arm will continue non-surgical management therapies to treat their CLBP and will be offered optional crossover after 12 months of follow-up. Subjects in the RF ablation arm will receive the Intracept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic type 1 or 2 changes. Subjects in the Control arm will continue non-surgical management therapies to treat their CLBP and will be offered optional crossover after 12 months of follow up.
**Long Term Follow-up**
2. US World Meds Study
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects with Chronic Non-Cancer Pain
This is a pilot, multicenter, randomized, double-blind, placebo-controlled, outpatient clinical trial to assess the safety and tolerability, and to estimate the effectiveness of LUCEMYRA for mitigating the symptoms of opioid withdrawal in the setting of an opioid taper in subjects with chronic non-cancer pain for a total of approximately 21 days.
**On Hold**
3. SKK/Rho Study
A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects with Lumbar Disc Herniation (Phase 3)
Multicenter, randomized, double-blind, sham- controlled, comparative study. The study duration for each subject will be approximately 56 weeks: a 4-week screening period, a 1-day treatment administration day, and a 52-week follow-up period. Subjects randomized to the SI-6603 treatment group will receive a single-dose injection of SI-6603 1.25 U into an intervertebral disc. Subjects randomized to the control group will receive a sham injection (the needle will not be placed in the disc).
**Enrolling**
4. Biogen/IQVIA Study
A Phase 3 Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Subjects with Trigeminal Neuralgia
Double-blind, randomized-withdrawal design to evaluate the efficacy and safety of BIIB074 compared with placebo. The study will also include an extension phase to evaluate the long-term safety profile and maintenance of effect of BIIB074in the treatment of pain associated with TN.
**Start-up**
5. Eliem LSR/Syneos Study
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects with Lumbosacral Radicular Pain
Prospective, Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of ETX-018810 in subjects 18-75 yrs with diagnosis of LSRP, with onset 3 mos + before screening, and at least moderate pain intensity on Patient Global Impression of Severity (PGI-S) scale. Includes screening period (max 4 weeks), 4-wk treatment period, and 1-wk post-treatment follow-up period (trial participation approx 9 weeks).
**Start-up**
6. Averitas PSNP/ICON Study
An interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial evaluating the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain
Interventional, Phase 3, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe PSNP.
**Start-up**
7. Eliem DPNP/Syneos Study
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects with Diabetic Peripheral Neuropathic Pain
Evaluate the efficacy of ETX-018810 on neuropathic pain via daily pain measurements in subjects with diabetic peripheral neuropathic pain (DPNP).
**Start-up**
For more information contact Translational Pain Research at (585) 340-8926 or painresearch@urmc.rochester.edu