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

Last updated: April 22, 2025
Sponsor: Merz Therapeutics GmbH
Overall Status: Active - Not Recruiting

Phase

2

Condition

Pain

Pain (Pediatric)

Treatment

IncobotulinumtoxinA

Placebo

Clinical Study ID

NCT06091020
M602011079
2022-501461-52-00
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronic peripheral neuropathic pain that persists for at least 6 months by the timeof the screening visit and is plausibly related to either an episode of herpeszoster or a peripheral nerve injury (caused by surgery or mechanical trauma).

  • Documented diagnosis of either chronic neuropathic pain after peripheral nerveinjury (i.e., postsurgical/post-traumatic neuropathic pain) or postherpeticneuralgia with at least probable level of certainty according to the NeuPSIG/IASP (Neuropathic Pain Special Interest Group / International Association on the Study ofPain) grading system.

  • A score of at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4)questionnaire.

Exclusion

Exclusion Criteria:

  • Complex Regional Pain Syndrome Type 1 and Type 2.

  • Any other painful condition or disease that requires treatment (only mild tomoderate 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 limbpain.

Study Design

Total Participants: 123
Treatment Group(s): 2
Primary Treatment: IncobotulinumtoxinA
Phase: 2
Study Start date:
November 22, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Merz Investigational Site #3590004

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Merz Investigational Site #3590002

    Sofia, 1784
    Bulgaria

    Site Not Available

  • Merz Investigational Site #3590005

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Merz Investigational Site #3590006

    Sofia, 1113
    Bulgaria

    Site Not Available

  • Merz Investigational Site #3590003

    Veliko Turnovo, 5000
    Bulgaria

    Site Not Available

  • Merz Investigational Site #0330066

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • Merz Investigational Site #0330065

    Limoges, 87042
    France

    Site Not Available

  • Merz Investigational Site #0330067

    Nîmes, 30029
    France

    Site Not Available

  • Merz Investigational Site #0490174

    Essen, 45147
    Germany

    Site Not Available

  • Merz Investigational Site #0490386

    Frankfurt, 60313
    Germany

    Site Not Available

  • Merz Investigational Site #0490389

    Hamburg, 20095
    Germany

    Site Not Available

  • Merz Investigational Site #0490388

    Kiel, 24105
    Germany

    Site Not Available

  • Merz Investigational Site #0490219

    Leipzig, 04103
    Germany

    Site Not Available

  • Merz Investigational Site #0490387

    Westerstede, 26655
    Germany

    Site Not Available

  • Merz Investigational Site #0360020

    Budapest, H-1122
    Hungary

    Site Not Available

  • Merz Investigational Site #0360021

    Budapest, H-1036
    Hungary

    Site Not Available

  • Merz Investigational Site #0360022

    Budapest, H-1145
    Hungary

    Site Not Available

  • Merz Investigational Site #0480113

    Czestochowa, 42-202
    Poland

    Site Not Available

  • Merz Investigational Site #0480112

    Gdynia, 81-537
    Poland

    Site Not Available

  • Merz Investigational Site #0480111

    Katowice, 40-040
    Poland

    Site Not Available

  • Merz Investigational Site #0480115

    Katowice, 40-282
    Poland

    Site Not Available

  • Merz Investigational Site #0480059

    Krakow, 30-539
    Poland

    Site Not Available

  • Merz Investigational Site #0480114

    Lublin, 20-078
    Poland

    Site Not Available

  • Merz Investigational Site #0480110

    Poznan, 60-702
    Poland

    Site Not Available

  • Merz Investigational Site #0480107

    Warszawa, 02-672
    Poland

    Site Not Available

  • Merz Investigational Site #0480109

    Warszawa, 00-710
    Poland

    Site Not Available

  • Merz Investigational Site #0480108

    Wroclaw, 50-381
    Poland

    Site Not Available

  • Merz Investigational Site #0340043

    Barcelona, 08035
    Spain

    Site Not Available

  • Merz Investigational Site #0340044

    Córdoba, 14029
    Spain

    Site Not Available

  • Merz Investigational Site #0340041

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Merz Investigational Site #0340042

    Sevilla, 41013
    Spain

    Site Not Available

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