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 neuropathic pain.
- Conditions
- Moderate to severe chronic peripheral neuropathic pain (PNP) due to postherpetic neuralgia (PHN) or peripheral nerve injury.MedDRA version: 20.0Level: LLTClassification code: 10077974Term: Peripheral neuropathic pain Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-501461-52-00
- Lead Sponsor
- Merz Therapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Chronic PNP 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 PHN with at least probable level of certainty according to the NeuPSIG/IASP grading system., A score of at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4) questionnaire.
Complex Regional Pain Syndrome Type 1 and Type 2., Any other painful condition or disease that requires regular 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 limb amputation and/or phantom limb pain.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish evidence of efficacy of NT 201 in the treatment of moderate to severe chronic PNP in patients with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury by demonstrating superiority compared to placebo in reducing Average Daily Pain (ADP) intensity.;Secondary Objective: To estimate the effect size of NT 201 in the treatment of moderate to severe chronic PNP in patients with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury compared to placebo in reducing the Neuropathic Pain Symptom Inventory (NPSI) total score., To demonstrate safety and tolerability of NT 201 compared to placebo in participants with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury.;Primary end point(s): Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Changes from baseline in NPSI total score at Weeks 2 to 12.;Secondary end point(s):Incidence of treatmentemergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.