A Clinical Trial to Investigate Efficacy and Safety of NT... | NCT06091020

Studies
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

NCT06091020

Sponsor

Merz Therapeutics GmbH

Status

Completed

Last Update Posted

May 5, 2026Actual

Enrollment

123Actual

Phase

Phase 2

Conditions

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

Interventions

IncobotulinumtoxinA
Placebo

Countries

Bulgaria
France
Germany
Hungary
Poland
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2022-501461-52-00	Other Identifier	EU Clinical Trial Number

Official 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

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2023Actual

Primary Completion Date

May 7, 2025Actual

Completion Date

Jul 4, 2025Actual

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 13, 2023

First Posted Date

Oct 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

May 4, 2026

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

May 5, 2026Actual

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NT 201	Experimental	Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area	Biological: IncobotulinumtoxinA
Placebo	Placebo Comparator	Subcutaneous injections of placebo into the peripheral neuropathic pain area	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IncobotulinumtoxinA	Biological	Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)	NT 201

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.		Baseline to week 2 to 12

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12		Baseline to week 2 to 12
Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merz Medical Expert	Merz Therapeutics GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Merz Investigational Site #3590004		Plovdiv		4000	Bulgaria
Merz Investigational Site #3590006

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D051474	Neuralgia, Postherpetic
D059348	Peripheral Nerve Injuries

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

ID	Term
C545476	incobotulinumtoxinA
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D045726	Metalloproteases
D001426	Bacterial Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001427	Bacterial Toxins
D014118	Toxins, Biological
D001685	Biological Factors