Back to resultsA 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)
Primary Purpose
Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IncobotulinumtoxinA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NT 201
Placebo
Arm Description
Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area
Subcutaneous injections of placebo into the peripheral neuropathic area
Outcomes
Primary Outcome Measures
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
Secondary Outcome Measures
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 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.
Full Information
NCT ID
NCT06091020
First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Merz Therapeutics GmbH
1. Study Identification
Unique Protocol Identification Number
NCT06091020
Brief Title
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
Acronym
PaiNT
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Therapeutics GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NT 201
Arm Type
Experimental
Arm Description
Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injections of placebo into the peripheral neuropathic area
Intervention Type
Biological
Intervention Name(s)
IncobotulinumtoxinA
Other Intervention Name(s)
Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins, NT 201
Intervention Description
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Primary Outcome Measure Information:
Title
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
Time Frame
Baseline to week 2 to 12
Secondary Outcome Measure Information:
Title
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
Time Frame
Baseline to week 2 to 12
Title
Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.
Time Frame
Baseline to week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Contact Point Clinical Trials
Phone
+49 69 1503 3030
Email
ctis@merz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz Therapeutics GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs