Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve InjuryPhase 2PaiNTNCT06091020
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
A Phase 2 study testing IncobotulinumtoxinA in people with Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury, run by Merz Therapeutics GmbH at 31 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
- What is being tested?
- IncobotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 22 Nov 2023to 4 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
Poland10 sites
Merz Investigational Site #0480113
Częstochowa, 42-202
Merz Investigational Site #0480112
Gdynia, 81-537
Merz Investigational Site #0480111
Katowice, 40-040
Merz Investigational Site #0480115
Katowice, 40-282
Merz Investigational Site #0480059
Krakow, 30-539
Merz Investigational Site #0480114
Lublin, 20-078
Merz Investigational Site #0480110
Poznan, 60-702
Merz Investigational Site #0480109
Warsaw, 00-710
Merz Investigational Site #0480107
Warsaw, 02-672
Merz Investigational Site #0480108
Wroclaw, 50-381
Germany6 sites
Merz Investigational Site #0490174
Essen, 45147
Merz Investigational Site #0490386
Frankfurt, 60313
Merz Investigational Site #0490389
Hamburg, 20095
Merz Investigational Site #0490388
Kiel, 24105
Merz Investigational Site #0490219
Leipzig, 04103
Merz Investigational Site #0490387
Westerstede, 26655
Bulgaria5 sites
Merz Investigational Site #3590004
Plovdiv, 4000
Merz Investigational Site #3590006
Sofia, 1113
Merz Investigational Site #3590005
Sofia, 1606
Merz Investigational Site #3590002
Sofia, 1784
Merz Investigational Site #3590003
Veliko Tarnovo, 5000
Spain4 sites
Merz Investigational Site #0340043
Barcelona, 08035
Merz Investigational Site #0340044
Córdoba, 14029
Merz Investigational Site #0340041
L'Hospitalet de Llobregat, 08907
Merz Investigational Site #0340042
Seville, 41013
France3 sites
Merz Investigational Site #0330066
Boulogne-Billancourt, 92100
Merz Investigational Site #0330065
Limoges, 87042
Merz Investigational Site #0330067
Nîmes, 30029
Hungary3 sites
Merz Investigational Site #0360021
Budapest, H-1036
Merz Investigational Site #0360020
Budapest, H-1122
Merz Investigational Site #0360022
Budapest, H-1145
About this study
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
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).
- Being tested
- IncobotulinumtoxinA, Placebo
- Medical subject headings
- Neuralgia, Postherpetic, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinABiological
Also called Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins, NT 201
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
PlaceboBiological
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
| Study group | Role | What they receive |
|---|---|---|
| NT 201 | Experimental | Subcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area Receives: Biological: IncobotulinumtoxinA |
| Placebo | Placebo comparator | Subcutaneous injections of placebo into the peripheral neuropathic pain area Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
Measured: Baseline to week 2 to 12
Secondary outcomes (2)
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
Measured: 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.
Measured: Baseline to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start22 Nov 2023
- Primary completion7 May 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Therapeutics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091020
- Sponsor's protocol ID
- M602011079
- Other IDs
- 2022-501461-52-00
- Acronym
- PaiNT
- Status last verified
- May 2026
- First submitted
- 13 Oct 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06091020
- Acronym / sponsor ID
- PaiNT / M602011079
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Merz Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT 201 | Experimental | Biological: IncobotulinumtoxinASubcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area |
| Placebo | Placebo comparator | Biological: PlaceboSubcutaneous injections of placebo into the peripheral neuropathic pain area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinAAlso: Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins, NT 201Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) | Biological | NT 201 |
| PlaceboSolution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). | Biological | Placebo |
Primary outcome
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
2 secondary outcomes
Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
Time frame: 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.
Time frame: Baseline to week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Therapeutics GmbH
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IncobotulinumtoxinA in people with Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury, run by Merz Therapeutics GmbH at 31 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Poland, Germany, Bulgaria, Spain, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.