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 (PaiNT)

April 18, 2024 updated by: Merz Therapeutics GmbH

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Contact Point Clinical Trials
  • Phone Number: +49 69 1503 3030
  • Email: ctis@merz.de

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Merz Investigational Site #3590004
      • Sofia, Bulgaria, 1784
        • Recruiting
        • Merz Investigational Site #3590002
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Merz Investigational Site #3590005
      • Sofia, Bulgaria, 1113
        • Recruiting
        • Merz Investigational Site #3590006
      • Veliko Turnovo, Bulgaria, 5000
        • Recruiting
        • Merz Investigational Site #3590003
  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Merz Investigational Site #0330066
      • Limoges, France, 87042
        • Recruiting
        • Merz Investigational Site #0330065
      • Nîmes, France, 30029
        • Recruiting
        • Merz Investigational Site #0330067
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Merz Investigational Site #0490174
      • Frankfurt, Germany, 60313
        • Recruiting
        • Merz Investigational Site #0490386
      • Hamburg, Germany, 20095
        • Recruiting
        • Merz Investigational Site #0490389
      • Kiel, Germany, 24105
        • Recruiting
        • Merz Investigational Site #0490388
      • Leipzig, Germany, 04103
        • Recruiting
        • Merz Investigational Site #0490219
      • Westerstede, Germany, 26655
        • Recruiting
        • Merz Investigational Site #0490387
  • Hungary
      • Budapest, Hungary, H-1122
        • Recruiting
        • Merz Investigational Site #0360020
      • Budapest, Hungary, H-1145
        • Recruiting
        • Merz Investigational Site #0360022
      • Budapest, Hungary, H-1036
        • Recruiting
        • Merz Investigational Site #0360021
  • Poland
      • Czestochowa, Poland, 42-202
        • Recruiting
        • Merz Investigational Site #0480113
      • Gdynia, Poland, 81-537
        • Recruiting
        • Merz Investigational Site #0480112
      • Katowice, Poland, 40-040
        • Recruiting
        • Merz Investigational Site #0480111
      • Katowice, Poland, 40-282
        • Recruiting
        • Merz Investigational Site #0480115
      • Krakow, Poland, 30-539
        • Recruiting
        • Merz Investigational Site #0480059
      • Lublin, Poland, 20-078
        • Recruiting
        • Merz Investigational Site #0480114
      • Poznan, Poland, 60-702
        • Recruiting
        • Merz Investigational Site #0480110
      • Warszawa, Poland, 02-672
        • Recruiting
        • Merz Investigational Site #0480107
      • Warszawa, Poland, 00-710
        • Recruiting
        • Merz Investigational Site #0480109
      • Wroclaw, Poland, 50-381
        • Recruiting
        • Merz Investigational Site #0480108
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Merz Investigational Site #0340043
      • Córdoba, Spain, 14029
        • Recruiting
        • Merz Investigational Site #0340044
      • Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Merz Investigational Site #0340041
      • Sevilla, Spain, 41013
        • Recruiting
        • Merz Investigational Site #0340042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NT 201
Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area
Biological: IncobotulinumtoxinA
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Other Names:
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Placebo Comparator: Placebo
Subcutaneous injections of placebo into the peripheral neuropathic area
Biological: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
Time Frame: Baseline to week 2 to 12
Baseline to week 2 to 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
Time Frame: Baseline to week 2 to 12
Baseline to week 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.
Time Frame: Baseline to week 20
Baseline to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Therapeutics GmbH

Investigators

  • Study Director: Merz Medical Expert, Merz Therapeutics GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M602011079
  • 2022-501461-52-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Clinical Trials on IncobotulinumtoxinA

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