NCT06091020

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

A Parallel-group Treatment, Proof-of-concept Phase 2, Multicenter, Double-blind, Randomized Two-arm Clinical Trial to Investigate the Efficacy and Safety of Subcutaneous NT 201 Injections Compared With Placebo Injections in Decreasing Pain Intensity in Male and Female Participants Aged 18 Years and Older With Moderate to Severe Chronic Peripheral Neuropathic Pain Due to Postherpetic Neuralgia or Peripheral Nerve Injury

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Merz Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury

Interventions

Type	Name	Description
BIOLOGICAL	IncobotulinumtoxinA	Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
BIOLOGICAL	Placebo	Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-05-07
• Completion: 2025-07-04
• First posted: 2023-10-19
• Last updated: 2025-07-24

Locations

31 sites across 6 countries: Bulgaria, France, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study