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
- Registration Number
- NCT06091020
- Lead Sponsor
- Merz Therapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Chronic peripheral neuropathic pain that persists for at least 6 months by the time<br> of the screening visit and is plausibly related to either an episode of herpes<br> zoster or a peripheral nerve injury (caused by surgery or mechanical trauma).<br><br> - Documented diagnosis of either chronic neuropathic pain after peripheral nerve<br> injury (i.e., postsurgical/post-traumatic neuropathic pain) or postherpetic<br> neuralgia with at least probable level of certainty according to the NeuPSIG/IASP<br> (Neuropathic Pain Special Interest Group / International Association on the Study of<br> Pain) grading system.<br><br> - A score of at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4)<br> questionnaire.<br><br>Exclusion Criteria:<br><br> - Complex Regional Pain Syndrome Type 1 and Type 2.<br><br> - Any other painful condition or disease that requires treatment (only mild to<br> moderate episodic migraine treated with triptans and/or non-steroidal anti-<br> inflammatory drugs (NSAIDs), if any, is acceptable).<br><br> - Postsurgical/post-traumatic neuropathic pain due to amputation and/or phantom limb<br> pain.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 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;Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.