CompletedPhase 2

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

Bulgaria, France, Germany123 participantsStarted 2023-11-22

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.

Timeframe: Baseline to week 2 to 12

Trial details

NCT IDNCT06091020

SponsorMerz Therapeutics GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-07

View on ClinicalTrials.gov More Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury trials