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 | Completed Phase 2 FDA Drug

• 2 other identifiers: M6020110792022-501461-52-00
• Study Type: interventional
• Target: 123
• Locations: 6 countries
• Sites: 31

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 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

Outcome Measures

Primary Outcomes (1)

• Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.

  Baseline to week 2 to 12

Secondary Outcomes (2)

• Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 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.

  Baseline to week 20

Study Arms (2)

NT 201

EXPERIMENTAL

Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area

Biological: IncobotulinumtoxinA

Placebo

PLACEBO COMPARATOR

Subcutaneous injections of placebo into the peripheral neuropathic pain area

Biological: Placebo

Interventions

IncobotulinumtoxinA BIOLOGICAL

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Also known as: Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins, NT 201

NT 201

Placebo BIOLOGICAL

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Therapeutics GmbH: lead

Study Sites (31)

Merz Investigational Site #3590004

Plovdiv, 4000, Bulgaria

Location

Merz Investigational Site #3590006

Sofia, 1113, Bulgaria

Location

Merz Investigational Site #3590005

Sofia, 1606, Bulgaria

Location

Merz Investigational Site #3590002

Sofia, 1784, Bulgaria

Location

Merz Investigational Site #3590003

Veliko Tarnovo, 5000, Bulgaria

Location

Merz Investigational Site #0330066

Boulogne-Billancourt, 92100, France

Location

Merz Investigational Site #0330065

Limoges, 87042, France

Location

Merz Investigational Site #0330067

Nîmes, 30029, France

Location

Merz Investigational Site #0490174

Essen, 45147, Germany

Location

Merz Investigational Site #0490386

Frankfurt, 60313, Germany

Location

Merz Investigational Site #0490389

Hamburg, 20095, Germany

Location

Merz Investigational Site #0490388

Kiel, 24105, Germany

Location

Merz Investigational Site #0490219

Leipzig, 04103, Germany

Location

Merz Investigational Site #0490387

Westerstede, 26655, Germany

Location

Merz Investigational Site #0360021

Budapest, H-1036, Hungary

Location

Merz Investigational Site #0360020

Budapest, H-1122, Hungary

Location

Merz Investigational Site #0360022

Budapest, H-1145, Hungary

Location

Merz Investigational Site #0480113

Częstochowa, 42-202, Poland

Location

Merz Investigational Site #0480112

Gdynia, 81-537, Poland

Location

Merz Investigational Site #0480111

Katowice, 40-040, Poland

Location

Merz Investigational Site #0480115

Katowice, 40-282, Poland

Location

Merz Investigational Site #0480059

Krakow, 30-539, Poland

Location

Merz Investigational Site #0480114

Lublin, 20-078, Poland

Location

Merz Investigational Site #0480110

Poznan, 60-702, Poland

Location

Merz Investigational Site #0480109

Warsaw, 00-710, Poland

Location

Merz Investigational Site #0480107

Warsaw, 02-672, Poland

Location

Merz Investigational Site #0480108

Wroclaw, 50-381, Poland

Location

Merz Investigational Site #0340043

Barcelona, 08035, Spain

Location

Merz Investigational Site #0340044

Córdoba, 14029, Spain

Location

Merz Investigational Site #0340041

L'Hospitalet de Llobregat, 08907, Spain

Location

Merz Investigational Site #0340042

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Peripheral Nerve Injuries

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Merz Medical Expert

  Merz Therapeutics GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: November 22, 2023
• Primary Completion: May 7, 2025
• Study Completion: July 4, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); HU (3); PL (10); ES (4); BU (5); FR (3)