Clinical trial NCT06091020: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
timeFrame: Baseline to week 2 to 12
Secondary outcomes:
measure: Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
timeFrame: Baseline to week 2 to 12
measure: Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.
timeFrame: Baseline to week 20
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Merz Investigational Site #3590004
city: Sofia
country: Bulgaria
facility: Merz Investigational Site #3590006
city: Sofia
country: Bulgaria
facility: Merz Investigational Site #3590005
city: Sofia
country: Bulgaria
facility: Merz Investigational Site #3590002
city: Veliko Turnovo
country: Bulgaria
facility: Merz Investigational Site #3590003
city: Boulogne-Billancourt
country: France
facility: Merz Investigational Site #0330066
city: Limoges
country: France
facility: Merz Investigational Site #0330065
city: Nîmes
country: France
facility: Merz Investigational Site #0330067
city: Essen
country: Germany
facility: Merz Investigational Site #0490174
city: Frankfurt
country: Germany
facility: Merz Investigational Site #0490386
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490389
city: Kiel
country: Germany
facility: Merz Investigational Site #0490388
city: Leipzig
country: Germany
facility: Merz Investigational Site #0490219
city: Westerstede
country: Germany
facility: Merz Investigational Site #0490387
city: Budapest
country: Hungary
facility: Merz Investigational Site #0360021
city: Budapest
country: Hungary
facility: Merz Investigational Site #0360020
city: Budapest
country: Hungary
facility: Merz Investigational Site #0360022
city: Czestochowa
country: Poland
facility: Merz Investigational Site #0480113
city: Gdynia
country: Poland
facility: Merz Investigational Site #0480112
city: Katowice
country: Poland
facility: Merz Investigational Site #0480111
city: Katowice
country: Poland
facility: Merz Investigational Site #0480115
city: Krakow
country: Poland
facility: Merz Investigational Site #0480059
city: Lublin
country: Poland
facility: Merz Investigational Site #0480114
city: Poznan
country: Poland
facility: Merz Investigational Site #0480110
city: Warszawa
country: Poland
facility: Merz Investigational Site #0480109
city: Warszawa
country: Poland
facility: Merz Investigational Site #0480107
city: Wroclaw
country: Poland
facility: Merz Investigational Site #0480108
city: Barcelona
country: Spain
facility: Merz Investigational Site #0340043
city: Córdoba
country: Spain
facility: Merz Investigational Site #0340044
city: Hospitalet de Llobregat
country: Spain
facility: Merz Investigational Site #0340041
city: Sevilla
country: Spain
facility: Merz Investigational Site #0340042
Study officials:
affiliation: Merz Therapeutics GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: