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
NCT ID: NCT06091020
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2023-11-22
2025-07-04
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NT 201
Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area
IncobotulinumtoxinA
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Placebo
Subcutaneous injections of placebo into the peripheral neuropathic pain area
Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merz Therapeutics GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Therapeutics GmbH
Locations
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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
Countries
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Other Identifiers
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2022-501461-52-00
Identifier Type: OTHER
Identifier Source: secondary_id
M602011079
Identifier Type: -
Identifier Source: org_study_id
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