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Completed

NCT Number: 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

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).

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Key information

Conditions

Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nerve Injuries Peripheral Nervous System Diseases Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Merz Investigational Site #3590004, Plovdiv, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IncobotulinumtoxinA

Biological

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

Other names: Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins, NT 201

Placebo

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12

    Time frame: Baseline to week 2 to 12

  2. 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

Sponsors and collaborators

Lead sponsor

Merz Therapeutics GmbH

Industry

Registry information

Official study 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

Acronym: PaiNT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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