409 Participants Needed

High-Dose vs Low-Dose Capsaicin for Neuropathic Pain

(RISE Trial)

Recruiting at 81 trial locations
CV
JV
LM
Overseen ByLizandra Marcondes
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Averitas Pharma, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

High-dose capsaicin patches, like Qutenza, are generally safe for treating neuropathic pain, with common side effects being temporary redness and pain at the application site.12456

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

I have had surgery that could cause persistent surgical pain.
I agree to follow the treatment rules and either am not on pain medication for nerve pain or have been on a stable dose for over 30 days.
I have moderate to severe pain, averaging at least 4 out of 10 in the last week.
See 7 more

Exclusion Criteria

I have severe pain from nerve damage and no planned painful procedures.
I have not had surgery for cancer, chronic pain conditions, or nerve issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Baseline

Baseline assessments conducted from Day -7 to Day -1

1 week

Treatment - Core Phase

Participants receive either Qutenza or low-dose capsaicin control from Day 1 to Week 12

12 weeks
Multiple visits for treatment and assessments

Treatment - Extension Phase

Continued treatment with Qutenza or low-dose capsaicin control from Week 13 to Week 42

30 weeks
Regular visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • capsaicin 0.04% topical system
  • Qutenza (capsaicin) 8% topical system
Trial OverviewThe trial is testing Qutenza (8% capsaicin) against a low-dose capsaicin (0.04%) for treating postsurgical neuropathic pain. Participants will be randomly assigned to either group in a double-blind manner, meaning neither they nor the researchers know who gets which treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Qutenza (capsaicin) 8% topical systemExperimental Treatment1 Intervention
Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)
Group II: Low-dose capsaicin controlActive Control1 Intervention
capsaicin 0.04% topical system

Find a Clinic Near You

Who Is Running the Clinical Trial?

Averitas Pharma, Inc.

Lead Sponsor

Trials
4
Recruited
630+

References

Assessment of the feasibility of high-concentration capsaicin patches in the pain unit of a tertiary hospital for a population of mixed refractory peripheral neuropathic pain syndromes in non-diabetic patients. [2018]
Capsaicin 179-mg cutaneous patch in the treatment of post-surgical neuropathic pain: a scoping review of current evidence and place in therapy. [2022]
Qutenza patch--our early experience. [2015]
High-Dose Capsaicin for the Treatment of Neuropathic Pain: What We Know and What We Need to Know. [2021]
Capsaicin 8 % Patch: A Review in Peripheral Neuropathic Pain. [2018]
[Capsaicin Cutaneous Patch: a Cost-consequences Study in a French University Hospital]. [2015]
Capsaicin 8% Patch Treatment in Non-Freezing Cold Injury: Evidence for Pain Relief and Nerve Regeneration. [2021]