Study on the Effectiveness and Safety of NT 201 Injections for Adults with Chronic Neuropathic Pain from Postherpetic Neuralgia or Nerve Injury

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called NT 201 on individuals experiencing chronic neuropathic pain. This type of pain can occur due to conditions like postherpetic neuralgia, which is pain following a shingles infection, or from a peripheral nerve injury, which might happen after surgery or an accident. The trial aims to see if NT 201 can effectively reduce pain intensity compared to a placebo. NT 201 is a form of Clostridium botulinum neurotoxin type A, which is administered through injections.

Participants in the study will receive either the NT 201 injections or placebo injections. The study will monitor changes in pain levels over several weeks to determine the effectiveness of the treatment. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, ensuring unbiased results. The study will also track any side effects that may arise during the treatment period.

The purpose of this trial is to gather evidence on whether NT 201 can provide relief for those suffering from moderate to severe chronic neuropathic pain. By comparing the effects of NT 201 to a placebo, researchers hope to establish its potential as a treatment option for managing this type of pain. Participants will be closely monitored throughout the study to ensure their safety and to collect accurate data on the treatment’s impact on their pain levels.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, your eligibility for the study will be confirmed based on specific criteria, such as having chronic neuropathic pain for at least 6 months.

You will be asked to complete a questionnaire to assess your pain level. This will help determine your baseline pain intensity.

2 randomization

After the initial visit, you will be randomly assigned to one of two groups. One group will receive the active treatment, NT 201, and the other group will receive a placebo.

This process is double-blind, meaning neither you nor the study staff will know which group you are in.

3 treatment administration

If you are in the active treatment group, you will receive NT 201 through a subcutaneous injection. This means the medication is injected under the skin.

The dosage and frequency of the injections will be determined by the study protocol and administered by qualified medical personnel.

4 follow-up visits

You will attend regular follow-up visits to monitor your progress and any changes in your pain levels. These visits will occur at specified intervals, such as every two weeks.

During these visits, you may be asked to complete additional questionnaires and undergo medical assessments to evaluate the effectiveness and safety of the treatment.

5 end of study

At the end of the study period, which is estimated to be around 12 weeks, you will have a final visit.

During this visit, your overall experience and any side effects will be reviewed. You will also receive information about the next steps, if applicable.

Who Can Join the Study?

  • The patient must have chronic peripheral neuropathic pain (PNP) that has lasted for at least 6 months. This pain should be related to either a past episode of herpes zoster (also known as shingles) or a peripheral nerve injury (caused by surgery or an accident).
  • The patient must have a documented diagnosis of either chronic neuropathic pain after a peripheral nerve injury (such as pain after surgery or an accident) or postherpetic neuralgia (PHN), which is pain following shingles. This diagnosis should be at least probably certain according to a specific grading system used by experts.
  • The patient must score at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4) questionnaire, which is a tool used to assess the type of pain.
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations, which means it considers people who might need special attention or care.

Who Cannot Join the Study?

  • Patients with any other type of chronic pain that is not related to postherpetic neuralgia (pain following shingles) or peripheral nerve injury (damage to the nerves outside the brain and spinal cord).
  • Patients who have a history of allergic reactions to the study medication or similar treatments.
  • Patients who are currently participating in another clinical trial.
  • Patients with any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have had major surgery within the past three months.
  • Patients with severe mental health conditions that are not well controlled.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Koranyi National Institute For Pulmonology Budapest Hungary
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Synexus Polska Sp. z o.o. Wroclaw Poland
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Clinical Best Solutions Sp. z o.o. S.K. Warsaw Poland
Hopital Ambroise Pare Boulogne-Billancourt France
Synexus Polska Sp. z o.o. Poznan Poland
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Synexus Polska Sp. z o.o. Warsaw Poland
SYNEXUS Magyarorszag Kft. Budapest Hungary
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire De Nimes Nimes France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Synexus Bulgaria EOOD Sofia Bulgaria
Silmedic Sp. z o.o. Katowice Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Westerstede Germany
Medical Center Medica Plus Ltd. Veliko Tirnovo Bulgaria
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Synexus Clinical Research GmbH Frankfurt Germany
Synexus Clinical Research GmbH Leipzig Germany
Snjdozk Pscpcq Sme z olms Gdynia Poland
Scugpxa Picpds Ssn z omgk Czestochowa Poland
Sbpbepg Pluorn Sgv z okmb Ogniayb w Kglzrmjwku Katowice Poland
Crqadv Hoimnzkidsa Ea Ulutkkhbaltwn Db Ltelhpv Limoges France
Uovlapfbloxcufgxjacga Ennym Afr Essen Germany
Hztqxnwe Vixw dftrdgvc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
20.03.2023
France France
Not recruiting
20.03.2023
Germany Germany
Not recruiting
20.03.2023
Hungary Hungary
Not recruiting
20.03.2023
Poland Poland
Not recruiting
20.03.2023
Spain Spain
Not recruiting
20.03.2023

Trial locations

NT 201 is a medication being tested in this clinical trial to see if it can help reduce pain for people who have chronic neuropathic pain. This type of pain can happen after conditions like postherpetic neuralgia, which is pain following shingles, or after an injury to the nerves. The trial is looking at how well NT 201 works in decreasing the intensity of this pain when given as an injection under the skin. The goal is to find out if NT 201 can make a significant difference in reducing daily pain levels compared to not using the medication.

Postherpetic Neuralgia – Postherpetic neuralgia is a condition characterized by persistent nerve pain following an outbreak of shingles, which is caused by the varicella-zoster virus. The pain is typically localized to the area where the shingles rash appeared and can be severe and debilitating. It is a type of neuropathic pain, meaning it results from nerve damage or dysfunction. The pain can be described as burning, stabbing, or aching, and may be accompanied by increased sensitivity to touch or temperature changes. Over time, the intensity of the pain may fluctuate, but it often persists for months or even years after the initial shingles infection has resolved.

Peripheral Neuropathic Pain – Peripheral neuropathic pain arises from damage or dysfunction of the peripheral nerves, which are the nerves outside the brain and spinal cord. This type of pain can result from various causes, including physical injury, infections, or systemic diseases like diabetes. The pain is often described as burning, tingling, or shooting, and it may be accompanied by numbness or weakness in the affected area. It can affect any part of the body but is most commonly experienced in the hands and feet. The progression of peripheral neuropathic pain can vary, with some individuals experiencing a gradual increase in symptoms, while others may have sudden and severe episodes.

Trial ID:
2022-501461-52-00
Protocol code:
M602011079
Trial Phase:
Therapeutic exploratory (Phase II)

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