A parallel-group treatment, proof-of-concept Phase 2, multicenter, double-blind, randomized 2 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 or severe chronic neuropathic pain due to postherpetic neuralgia or peripheral nerve injury.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501461-52-00

Acronym

M602011079

Enrollment

120

Registered

2023-04-18

Start date

2023-10-17

Completion date

2025-07-04

Last updated

2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe chronic peripheral neuropathic pain (PNP) due to postherpetic neuralgia (PHN) or peripheral nerve injury.

Brief summary

Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.

Detailed description

Changes from baseline in NPSI total score at Weeks 2 to 12., Incidence of treatmentemergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.

Interventions

DRUGXEOMIN 100 Einheiten Pulver zur Herstellung einer Injektionslösung

DRUGPlacebo to NT 201

DRUGCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD)

DRUGFREE OF COMPLEXING PROTEINS

DRUGPARACETAMOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.	—

Secondary

Measure	Time frame
Changes from baseline in NPSI total score at Weeks 2 to 12., Incidence of treatmentemergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.	—

Countries

Bulgaria, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026