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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

NCT06091020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-05-05

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Merz Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Therapeutics GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2025-05-07
Completion
2025-07-04
FDA Drug
Yes

Countries

  • Bulgaria
  • France
  • Germany
  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091020 on ClinicalTrials.gov