A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve Injury
- Conditions
- Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
- Interventions
- Biological: Placebo
- Registration Number
- NCT06091020
- Lead Sponsor
- Merz Therapeutics GmbH
- Brief Summary
In this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo.
Trial details include:
* Trial duration: 22-23 weeks;
* Treatment duration: 1 injection visit with a 20-week follow-up period;
* Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
- Chronic peripheral neuropathic pain that persists for at least 6 months by the time of the screening visit and is plausibly related to either an episode of herpes zoster or a peripheral nerve injury (caused by surgery or mechanical trauma).
- Documented diagnosis of either chronic neuropathic pain after peripheral nerve injury (i.e., postsurgical/post-traumatic neuropathic pain) or postherpetic neuralgia with at least probable level of certainty according to the NeuPSIG/IASP (Neuropathic Pain Special Interest Group / International Association on the Study of Pain) grading system.
- A score of at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4) questionnaire.
- Complex Regional Pain Syndrome Type 1 and Type 2.
- Any other painful condition or disease that requires treatment (only mild to moderate episodic migraine treated with triptans and/or non-steroidal anti- inflammatory drugs (NSAIDs), if any, is acceptable).
- Postsurgical/post-traumatic neuropathic pain due to amputation and/or phantom limb pain.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NT 201 IncobotulinumtoxinA Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area Placebo Placebo Subcutaneous injections of placebo into the peripheral neuropathic pain area
- Primary Outcome Measures
Name Time Method Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12. Baseline to week 2 to 12
- Secondary Outcome Measures
Name Time Method Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12 Baseline to week 2 to 12 Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study. Baseline to week 20
Trial Locations
- Locations (31)
Merz Investigational Site #3590004
🇧🇬Plovdiv, Bulgaria
Merz Investigational Site #3590006
🇧🇬Sofia, Bulgaria
Merz Investigational Site #3590005
🇧🇬Sofia, Bulgaria
Merz Investigational Site #3590002
🇧🇬Sofia, Bulgaria
Merz Investigational Site #3590003
🇧🇬Veliko Turnovo, Bulgaria
Merz Investigational Site #0330066
🇫🇷Boulogne-Billancourt, France
Merz Investigational Site #0330065
🇫🇷Limoges, France
Merz Investigational Site #0330067
🇫🇷Nîmes, France
Merz Investigational Site #0490174
🇩🇪Essen, Germany
Merz Investigational Site #0490386
🇩🇪Frankfurt, Germany
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