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Study on the Effectiveness and Safety of NT 201 (Botulinum Toxin) for Treating Lower Limb Spasticity in Adults After Stroke or Traumatic Brain 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, also known as botulinum toxin, on a condition called lower limb spasticity. Lower limb spasticity is a condition where muscles in the legs become stiff and difficult to move, often occurring after a stroke or traumatic brain injury. The study aims to compare the effectiveness and safety of NT 201 with a placebo in treating this condition.

Participants in the study will receive injections of NT 201 or a placebo into the muscles of the lower limbs. The treatment period will last for up to 92 days. The study will monitor changes in muscle stiffness and any side effects that may occur. The goal is to determine if NT 201 can help reduce muscle stiffness and improve movement in the affected limbs.

The study will also include an open-label extension phase, where all participants may receive NT 201, with or without additional treatment for the upper limbs. This phase will help gather more information on the long-term effects and safety of the treatment. The study is designed to provide valuable insights into the potential benefits of NT 201 for individuals with lower limb spasticity due to stroke or traumatic brain injury.

1 joining the study

Upon joining the study, the participant is confirmed to meet the eligibility criteria, which include being between 18 and 85 years old and having lower limb spasticity due to stroke or traumatic brain injury.

The participant must have a specific level of spasticity in the ankle and a certain range of motion.

2 initial assessment

An initial assessment is conducted to establish a baseline for the participant’s condition. This includes measuring the spasticity level using the Modified Ashworth Scale and assessing the range of motion in the ankle.

3 treatment administration

The participant receives an intramuscular injection of NT 201 (botulinum toxin) or a placebo. The dosage is 400 Units, specifically targeting the ankle plantar flexors.

This treatment aims to reduce spasticity in the lower limb.

4 follow-up assessments

Follow-up assessments occur at Weeks 4 and 6. These assessments measure changes in spasticity and overall improvement using the Modified Ashworth Scale and the Goal Attainment Scale.

The participant’s progress is evaluated by both the physician and the participant.

5 safety monitoring

Throughout the study, the participant is monitored for any adverse effects related to the treatment. This includes tracking any new symptoms or changes in health status.

6 study completion

Upon completion of the study period, the participant undergoes a final assessment to evaluate the overall effectiveness and safety of the treatment.

The results contribute to understanding the treatment’s impact on lower limb spasticity.

Who Can Join the Study?

  • Participants must be female or male and between 18 and 85 years old.
  • Participants must have a diagnosis of lower limb spasticity, which means their muscles are stiff or tight, possibly with or without similar issues in the upper limb on the same side of the body. This condition should be caused by a stroke or traumatic brain injury.
  • Participants must have disabling ankle flexor spasticity, which means difficulty in moving the ankle due to muscle stiffness, presenting as pes equinus (toe walking) or pes equinovarus (toe walking with inward foot turning).
  • Participants must have a Modified Ashworth Scale-Bohannon (MAS) score of 2 or 3 points in the ankle plantar flexor of the affected lower limb. This scale measures muscle stiffness.
  • Participants must have a minimum passive range of motion in the ankle of the affected lower limb: 10 degrees dorsiflexion (upward movement) and 20 degrees plantarflexion (downward movement).
  • Participants must have had their last botulinum neurotoxin (BoNT) injection for treating spasticity or any other condition at least 4 months ago.
  • For participants on anticoagulation therapy (medication to prevent blood clots), the investigator must confirm and document that the participant has:
    • An activated partial thromboplastin time (aPTT) of 80 seconds or less for those on dabigatran or other direct thrombin inhibitors.
    • An international normalized ratio (INR) value of 2.5 or less for those on coumarins or other anticoagulants monitored by INR.

Who Cannot Join the Study?

  • Individuals who are not adults cannot participate. This means only people who are 18 years or older can join.
  • People who do not have lower limb spasticity cannot take part. Lower limb spasticity is a condition where muscles in the legs are too tight, making movement difficult.
  • Participants must have issues specifically with the ankle plantar flexors. These are the muscles that help point your toes down.
  • Both men and women can participate, but they must meet all other criteria.
  • People who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who might need special protection, like those with certain health conditions or disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki Lodz Poland
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Universitaetsklinikum Aachen AöR Aachen Germany
University Hospital Bratislava Bratislava Slovakia
Fakultna Nemocnica Trnava Trnava Slovakia
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
Szent Damjan Goeroegkatolikus Korhaz Kisvarda Hungary
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Instytut Psychiatrii I Neurologii Warsaw Poland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
University Childrens Hospital Queen Fabiola Brussels Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Neurologie and Rehabilitace Brno Czechia
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Lublin Poland
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
Centrum Kompleksowej Rehabilitacji Sp. z o.o. Warsaw Poland
Urduzenssn Mzejcws Cvkepo Hfqneeptiuskrzgds Hamburg Germany
Njmbyp Dgvlgzaypvm I Twgegsn Nkwgpawoizaud Wroclaw Poland
Pslhjcw Sxrenigdofz Slhqudga Warsaw Poland
Rhjwxksnmtoplajz Hdokzdrb Garches France
Uknsszbhcdfsmgwcsfyhx Ddfrjldnhsn Aqi Duesseldorf Germany
Gphlvudfepnkjvagi Vjdxohbqw Pblc Aretaq Eoypzqkq Omjviv Kndblv Gyor Hungary
Arpwtjt Ofsrxwsxdgc Ugtuvglsdokae Ocrjtqvg Rponexi Foggia Italy
Ufwzjmhagdeytjuqjpqcu Wxfaychol Apv Wuerzburg Germany
Fvvroizuv Pkgb Ls Iveqlngtnqybj Bujetdfjg Dri Hghnqgqy Utrnqpdgaoxay Lx Pdl Madrid Spain
Hherdzov Ukzbpenqvdctgv Swzmwxsprg &zrnjgx Hhlahat dw Hrfnqfnmgij STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.09.2019
Czechia Czechia
Not recruiting
02.09.2019
France France
Not recruiting
02.09.2019
Germany Germany
Not recruiting
02.09.2019
Hungary Hungary
Not recruiting
02.09.2019
Italy Italy
Not recruiting
02.09.2019
Poland Poland
Not recruiting
02.09.2019
Slovakia Slovakia
Not recruiting
02.09.2019
Spain Spain
Not recruiting
02.09.2019

Trial locations

Investigated drugs:

NT 201 is a medication being studied for its effectiveness and safety in treating lower limb spasticity in adults. This condition can occur after a stroke or traumatic brain injury and involves muscle stiffness, particularly in the ankle area. The trial aims to determine how well this medication works in reducing spasticity and improving movement.

Investigated diseases:

Lower Limb Spasticity – Lower limb spasticity is a condition characterized by increased muscle tone and stiffness in the legs, often resulting from damage to the brain or spinal cord. This condition can lead to difficulty in movement, coordination, and walking, as the muscles may contract involuntarily. It commonly affects the ankle plantar flexors, causing the foot to point downward and making it challenging to place the heel on the ground. Over time, spasticity can lead to muscle shortening and joint deformities if not managed properly. The severity of symptoms can vary, and they may fluctuate depending on factors such as stress, temperature, or fatigue.

Trial ID:
2023-505810-12-00
Protocol code:
M602011014
NCT ID:
NCT03992404
Trial Phase:
Therapeutic confirmatory (Phase III)

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