High-Dose vs Low-Dose Capsaicin for Neuropathic Pain
(RISE Trial)
Trial Summary
What is the purpose of this trial?
This is an interventional, Phase III, 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 postsurgical neuropathic pain (PSNP).
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, if you are already on a stable treatment for your pain that started more than 30 days before joining the trial, you may continue with it.
What data supports the effectiveness of the capsaicin treatment for neuropathic pain?
Research shows that the high-dose capsaicin patch (Qutenza) can significantly reduce pain in people with peripheral neuropathic pain, including those with postherpetic neuralgia and diabetic peripheral neuropathy. In studies, patients experienced improved pain relief and sleep quality, and some reported reduced medication use and better daily activities.12345
Is high-dose capsaicin safe for treating neuropathic pain?
How does the drug Qutenza differ from other treatments for neuropathic pain?
Qutenza is unique because it is a high-dose capsaicin patch applied directly to the skin, providing targeted pain relief for neuropathic pain without the systemic side effects often associated with oral medications. It works by desensitizing pain receptors in the skin, offering pain relief for up to three months after a single application.12357
Eligibility Criteria
Adults aged 18+ with moderate to severe nerve pain following surgery, who can apply the treatment on intact skin and agree to use birth control if applicable. Excluded are those with confounding conditions like deep tissue pain, planned painful procedures during the trial, or surgeries related to cancer.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments conducted from Day -7 to Day -1
Treatment - Core Phase
Participants receive either Qutenza or low-dose capsaicin control from Day 1 to Week 12
Treatment - Extension Phase
Continued treatment with Qutenza or low-dose capsaicin control from Week 13 to Week 42
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- capsaicin 0.04% topical system
- Qutenza (capsaicin) 8% topical system
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Who Is Running the Clinical Trial?
Averitas Pharma, Inc.
Lead Sponsor