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 (PaiNT)

Merz Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury

Treatments: Biological: IncobotulinumtoxinA; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06091020

2022-501461-52-00 (Other Identifier)

M602011079

Details and patient eligibility

About

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).

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 2 patient groups, including a placebo group

NT 201

Experimental group

Description:

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

Treatment:

Biological: IncobotulinumtoxinA

Placebo

Placebo Comparator group

Description:

Subcutaneous injections of placebo into the peripheral neuropathic pain area

Treatment:

Biological: Placebo