Status:
COMPLETED
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
Lead Sponsor:
Merz Therapeutics GmbH
Conditions:
Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 com...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2025
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT06091020
Start Date
November 22 2023
End Date
July 4 2025
Last Update
July 24 2025
Active Locations (31)
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1
Merz Investigational Site #3590004
Plovdiv, Bulgaria, 4000
2
Merz Investigational Site #3590006
Sofia, Bulgaria, 1113
3
Merz Investigational Site #3590005
Sofia, Bulgaria, 1606
4
Merz Investigational Site #3590002
Sofia, Bulgaria, 1784