Study on IPN10200 for Treating Cervical Dystonia in Adults

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What is this study about?

This clinical trial is focused on studying a condition known as Cervical Dystonia, which affects the muscles in the neck, causing involuntary contractions and abnormal movements or postures. The study is testing a new treatment called IPN10200, which is a solution for injection containing a substance known as Clostridium botulinum, neurotoxin serotype A/B. This treatment is being compared to a placebo to see how effective it is in reducing the symptoms of cervical dystonia.

The purpose of the study is to evaluate how well IPN10200 works in reducing the symptoms of cervical dystonia in adults. Participants in the study will receive either the IPN10200 injection or a placebo. The study will monitor changes in symptoms over time, with a particular focus on the first four weeks after treatment. Participants will be assessed at various points up to 36 weeks to track any changes in their condition and to monitor for any side effects.

Throughout the study, participants will be asked to report on their symptoms, including pain levels and how the condition affects their daily activities. The study will also look at how quickly participants experience relief from symptoms and how long the effects of the treatment last. Safety will be closely monitored, including any potential side effects or changes in health status. The goal is to gather comprehensive information on the effectiveness and safety of IPN10200 as a treatment option for cervical dystonia.

1 initial visit and screening

Upon joining the study, an initial visit is conducted to confirm eligibility. This involves a clinical diagnosis of cervical dystonia, which affects the head, neck, and shoulders. The severity of symptoms is assessed using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).

The TWSTRS measures the severity, disability, and pain associated with cervical dystonia. Scores must meet specific criteria to proceed.

2 randomization and treatment assignment

Participants are randomly assigned to receive either the study medication IPN10200 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is given.

The medication is administered as a solution for injection into the muscles, specifically designed for intramuscular use.

3 treatment administration

The study medication or placebo is injected at the start of the trial. The goal is to assess the effectiveness of IPN10200 in reducing symptoms of cervical dystonia.

Participants will be monitored for changes in symptoms, particularly at week 4 after the injection.

4 follow-up visits and assessments

Regular follow-up visits are scheduled to monitor progress and assess any changes in symptoms. These visits continue until week 36.

During these visits, various scales and questionnaires are used to evaluate symptom changes, including the TWSTRS and the Numerical Rating Scale (NRS) for pain.

5 monitoring and safety assessments

Throughout the trial, participants are monitored for any adverse events or side effects. This includes regular checks of vital signs, laboratory tests, and physical examinations.

The presence of any antibodies to the study medication is also assessed to ensure safety and effectiveness.

6 final evaluation and study completion

At the end of the study period, a final evaluation is conducted to assess the overall impact of the treatment on cervical dystonia symptoms.

Participants’ experiences and outcomes are documented to contribute to the study’s findings on the efficacy and safety of IPN10200.

Who Can Join the Study?

Must have a clinical diagnosis of isolated Cervical Dystonia (CD), which is a condition affecting the muscles in the neck, head, and shoulders.
Symptoms must be at least moderate in severity, as measured by specific scores on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS):
- Total score of 20 or higher
- Severity subscale score of 15 or higher
- Disability subscale score of 3 or higher
- Pain subscale score of 1 or higher
Can be either new to or experienced with BoNT therapy for Cervical Dystonia. BoNT therapy refers to treatments using botulinum toxin.
Must be an adult, aged 18 years or older.
Both males and females are eligible to participate.

Who Cannot Join the Study?

Patients with any other significant medical condition that might interfere with the study.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy or sensitivity to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse within the past year.
Patients who have received any other treatment for Cervical Dystonia within a certain period before the study starts.
Patients with a history of certain neurological disorders, which are conditions affecting the brain, spine, and nerves.
Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Futuremeds Sp. z o.o.	Wroclaw	Poland
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France
GFO Kliniken Troisdorf, Betriebsstaette St. Johannes	Troisdorf	Germany

Other Sites

Site Name	City	Country
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Centre Hospitalier Universitaire De Nimes	Nimes	France
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Neurohk s.r.o.	Chocen	Czechia
Specjalistyczne Gabinety Sp. z o.o.	Cracow	Poland
curiositas ad sanum Studien und Beratungs GmbH	Haag in Obb	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Udfelvfqrd Mlbvuxx Cxvpdz Hrocnaycogepebqsu	Hamburg	Germany
Hnrztvrc Uguhacwhkkopd Dv Lf Pvcvptga	Madrid	Spain
Paiqstpoov Sycynapfxq Hylmlzbf Teghu Ja Gapajczfhc	Wroclaw	Poland
Emfrmwm Posnqrdey Ssk z ohch	Pabianice	Poland
Anqbaeipme Pymtytdh Hdicyjup Dj Mzvucsdhd	Marseille	France
Ajrzexn Use Ienyn Dw Rgpjik Eszews	Reggio Emilia	Italy
Hddyjjag Dk Ly Skykd Cjxk I Sfif Pfg	Barcelona	Spain
Mvojzrslld swfncs	Brno	Czechia
Iyetoquk Zhdzjej Dk Btskjalhjultcuviw	Oświęcim	Poland
Isfwz Owtxviis Ajysllbacd Sac Lgpo	Milan	Italy
Hwghqfck Uppfqijvuljykj Sjjfjbzlqk &dhowcu Hsokpzb dn Houodmwjymt	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	12.06.2025
France	Recruiting	12.06.2025
Germany	Recruiting	12.06.2025
Italy	Recruiting	12.06.2025
Poland	Recruiting	12.06.2025
Spain	Recruiting	12.06.2025

Trial locations

Investigated drugs:

Clostridium Botulinum, Neurotoxin Serotype A/B

IPN10200 is a medication being studied for its potential to help people with cervical dystonia, a condition that causes involuntary muscle contractions in the neck. This medication is being tested to see if it can reduce the symptoms of cervical dystonia, such as neck pain and abnormal head positions. The goal of the study is to determine if IPN10200 can improve the quality of life for people suffering from this condition by making their symptoms less severe.

Cervical Dystonia – Cervical Dystonia is a neurological disorder characterized by involuntary muscle contractions in the neck, leading to abnormal movements and awkward postures of the head and neck. These muscle contractions can cause the head to twist or tilt to one side, forward, or backward. The condition often results in discomfort and pain due to the sustained muscle contractions. Symptoms can vary in severity and may fluctuate over time, sometimes worsening with stress or activity. The disorder can affect daily activities and quality of life, as the abnormal postures can be persistent or intermittent. The exact cause of Cervical Dystonia is not well understood, but it is believed to involve dysfunction in the brain areas that control movement.

Trial ID:

2024-519248-34-00

Protocol code:

CLIN-10200-457

NCT ID:

NCT06937931

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on IPN10200 for Treating Cervical Dystonia in Adults

What is this study about?

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