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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
Sponsor: Merz Therapeutics GmbH
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2023-11-22
Completion Date
2025-07-04
Last Updated
2026-05-05
Healthy Volunteers
No
Interventions
IncobotulinumtoxinA
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Locations (31)
Merz Investigational Site #3590004
Plovdiv, Bulgaria
Merz Investigational Site #3590006
Sofia, Bulgaria
Merz Investigational Site #3590005
Sofia, Bulgaria
Merz Investigational Site #3590002
Sofia, Bulgaria
Merz Investigational Site #3590003
Veliko Tarnovo, Bulgaria
Merz Investigational Site #0330066
Boulogne-Billancourt, France
Merz Investigational Site #0330065
Limoges, France
Merz Investigational Site #0330067
Nîmes, France
Merz Investigational Site #0490174
Essen, Germany
Merz Investigational Site #0490386
Frankfurt, Germany
Merz Investigational Site #0490389
Hamburg, Germany
Merz Investigational Site #0490388
Kiel, Germany
Merz Investigational Site #0490219
Leipzig, Germany
Merz Investigational Site #0490387
Westerstede, Germany
Merz Investigational Site #0360021
Budapest, Hungary
Merz Investigational Site #0360020
Budapest, Hungary
Merz Investigational Site #0360022
Budapest, Hungary
Merz Investigational Site #0480113
Częstochowa, Poland
Merz Investigational Site #0480112
Gdynia, Poland
Merz Investigational Site #0480111
Katowice, Poland
Merz Investigational Site #0480115
Katowice, Poland
Merz Investigational Site #0480059
Krakow, Poland
Merz Investigational Site #0480114
Lublin, Poland
Merz Investigational Site #0480110
Poznan, Poland
Merz Investigational Site #0480109
Warsaw, Poland
Merz Investigational Site #0480107
Warsaw, Poland
Merz Investigational Site #0480108
Wroclaw, Poland
Merz Investigational Site #0340043
Barcelona, Spain
Merz Investigational Site #0340044
Córdoba, Spain
Merz Investigational Site #0340041
L'Hospitalet de Llobregat, Spain
Merz Investigational Site #0340042
Seville, Spain