Ongoing Clinical Trials for Muscle Spasticity
Currently, there are 7 ongoing clinical trials investigating treatments for muscle spasticity, a condition characterized by continuous muscle contraction causing stiffness and tightness. These studies are evaluating various botulinum toxin products and other medications across multiple countries in Europe, with particular focus on spasticity following stroke, spinal cord injury, and cerebral palsy.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- France
- Germany
- Hungary
- Italy
- Latvia
- Poland
- Spain
- Study comparing Dry Needling and Botulinum Toxin Type A treatments for leg muscle stiffness in stroke patients
- Study of individualized doses of botulinum toxin type A (incobotulinumtoxin) in adults with severe spasticity caused by brain damage
- Study on the Safety and Effectiveness of IPN10200 for Treating Upper Limb Spasticity in Adults After Stroke or Brain Injury
Study comparing Dry Needling and Botulinum Toxin Type A treatments for leg muscle stiffness in stroke patients
This trial compares two different approaches for treating leg muscle stiffness in people who have had a stroke. The study investigates whether Botulinum Toxin Type A injections or Dry Needling treatment is more effective for reducing muscle tightness in the lower legs.
Main inclusion criteria: Participants must be between 18 and 85 years old and experiencing their first stroke that occurred within the last 12 months. They must have muscle stiffness in the lower leg muscles and at least 20 degrees of ankle movement. Participants should be able to walk independently, with or without walking aids, and must not have previously received Dry Needling or Botulinum Toxin treatments for this condition.
Main exclusion criteria: People cannot join if they are younger than 18 or older than 65, have allergic reactions to botulinum toxin, active infections in treatment areas, severe heart conditions, are pregnant or breastfeeding, use blood-thinning medications, have metal implants in the treatment area, experienced a stroke within the last 3 months, have severe cognitive impairment, uncontrolled epilepsy, or active skin conditions in the treatment area.
Treatment focus: The study will track improvements over 19 weeks through regular assessments of muscle stiffness, walking ability, and quality of life. Participants will receive either Botox injections (up to 400 units) or dry needling treatment, with weekly monitoring of ankle muscle stiffness and regular ultrasound imaging of leg muscles.
Investigational drugs: The study uses Botulinum Toxin Type A, which blocks nerve signals to muscles to help relax overly tight muscles, and Dry Needling as an alternative therapy involving thin needles inserted into specific muscle points.
Study of individualized doses of botulinum toxin type A (incobotulinumtoxin) in adults with severe spasticity caused by brain damage
This study evaluates how well IncobotulinumtoxinA works when customized for each person’s specific needs. It focuses on adults with severe muscle stiffness affecting both arms and legs due to brain damage.
Main inclusion criteria: Participants must be at least 18 years old with severe muscle stiffness in both upper and lower limbs caused by brain damage. They must require treatment with IncobotulinumtoxinA at a dose of 800 units or higher and be willing to complete pain assessments, muscle tone measurements, and daily activity evaluations. They must have no medical conditions preventing botulinum toxin treatment.
Main exclusion criteria: People cannot participate if they are younger than 18 or older than 65, pregnant or breastfeeding, have previous allergic reactions to botulinum toxin, active infections at injection sites, fixed contractures in affected limbs, have used interacting medications within 3 months, participated in other trials within 3 months, have severe medical conditions, neuromuscular junction disorders, are taking anticoagulants, have severe swallowing difficulties, or have active skin conditions at injection sites.
Treatment focus: Participants will receive a single injection of IncobotulinumtoxinA at their initial visit, with follow-up evaluations at 6 weeks and 12 weeks. The study measures improvements in muscle stiffness using the Ashworth scale, pain levels using a visual scale, and ability to perform daily activities using the Barthel scale.
Investigational drugs: IncobotulinumtoxinA is injected directly into affected muscles to temporarily block nerve signals, causing muscle relaxation and reducing abnormal contractions and stiffness.
Study on Botulinum Toxin Type A for Treating Spastic Equinovarus in First-Time Stroke Patients
This trial studies the effects of Botulinum Toxin Type A (Dysport) on spastic equinovarus, a condition involving muscle tightness and abnormal foot positioning that makes walking difficult after a stroke.
Main inclusion criteria: Participants must be at least 18 years old, have experienced their first-ever stroke affecting only one side of the body, and have spastic equinovarus requiring Botulinum Neurotoxin injection in the lower leg. If they have had previous botulinum toxin injections in the muscles being studied, it must have been at least 3 months ago. Participants must use highly effective birth control methods during the study.
Main exclusion criteria: People who have not experienced their first-ever stroke, do not have spastic equinovarus, are not within the specified age range, or are part of a vulnerable population requiring special protection cannot participate.
Treatment focus: The study uses advanced techniques including Three Dimensional freehand Ultrasound and Instrumented Spasticity Assessment to observe changes in muscles, tendons, and nerves following treatment. Participants will be monitored regularly until the end of 2026 to evaluate long-term response and optimize future treatment strategies.
Investigational drugs: Dysport 500 U (Botulinum Neurotoxin Type A) is administered as an intramuscular injection to temporarily relax muscles by blocking acetylcholine release, which is responsible for muscle contraction.
Study on the Safety and Effectiveness of IncobotulinumtoxinA for Treating Limb Spasticity in Children with Cerebral Palsy
This trial investigates IncobotulinumtoxinA (XEOMIN) for treating muscle stiffness in the arms and legs of children with cerebral palsy. The study involves adjusting doses to find the most effective amount for each child over three injection cycles.
Main inclusion criteria: Children must be between 2 and 17 years old with upper and lower limb muscle stiffness due to cerebral palsy. They must have a Gross Motor Function Classification System level from II to V and muscle stiffness scored at least 2 points on the Ashworth scale. The investigator must determine they need a total body dose up to 22 units per kilogram (maximum 550 units). If previously treated with Botulinum Toxin A, the last injection must have been at least 5 months ago.
Main exclusion criteria: Children with allergic reactions to IncobotulinumtoxinA or its ingredients, other medical conditions interfering with study results, current participation in another trial, botulinum toxin treatment within 12 weeks, muscle weakness or nerve disorders unrelated to cerebral palsy, pregnancy or breastfeeding status, or inability to follow study procedures cannot participate.
Treatment focus: The study spans up to 60 weeks with three injection cycles and observation periods of 12 to 20 weeks after each injection. Children will be monitored for changes in muscle stiffness using the Ashworth scale, Resistance to Passive Movement Scale, and other assessment tools to evaluate treatment effectiveness and safety.
Investigational drugs: IncobotulinumtoxinA works by blocking acetylcholine release, relaxing muscles and reducing discomfort. The trial aims to determine optimal dosing for children who have never been treated or have been treated with similar medications previously.
Study on the Safety and Effectiveness of IPN10200 for Treating Upper Limb Spasticity in Adults After Stroke or Brain Injury
This multi-stage trial tests a new medication called IPN10200, a type of botulinum toxin, for treating arm muscle stiffness after stroke or traumatic brain injury. The study compares IPN10200 to both Dysport and placebo.
Main inclusion criteria: Participants must be between 18 and 70 years old (18 to 65 for dose escalation phase) in good general health with no uncontrolled diseases. They must have muscle stiffness on one side of the body following stroke or traumatic brain injury that occurred at least 6 months ago. They must have a Modified Ashworth Scale score of 2 or more in the muscle group to be injected and an angle of spasticity of 5 degrees or more. If previously treated with botulinum toxin, the last injection must have been at least 4 months before study start.
Main exclusion criteria: People who have not experienced a stroke or traumatic brain injury affecting the upper limb, are not within the specified age range, or are not male or female cannot participate.
Treatment focus: The study progresses through three stages: initial dose escalation to assess safety and select two dose levels, dose finding to identify the lowest safe and effective dose compared to Dysport, and efficacy assessment comparing IPN10200 to placebo. An open-label extension period follows, allowing continued treatment to observe long-term safety and effectiveness over multiple cycles.
Investigational drugs: IPN10200 is administered as an intramuscular injection to help manage upper limb muscle stiffness. The trial explores optimal dosing that reduces muscle stiffness while ensuring patient safety. Dysport is used as a comparison medication already approved for treating this condition.
Study on Riluzole for Reducing Spasticity in Patients with Chronic Spinal Cord Injury
This adaptive trial investigates whether Riluzole can help improve muscle stiffness in people with chronic spinal cord injury. The study aims to find the most effective dose and compare it against placebo.
Main inclusion criteria: Participants must have chronic traumatic spinal cord injury that occurred at least 12 months ago and experience muscle stiffness. They must be between 18 and 65 years old, able to provide written informed consent, and judged by investigators as able to follow study procedures. Previous Botulinum Toxin A injections must have been more than 3 months ago, baclofen injections or muscle relaxants more than 14 days ago for Step 1, with stable doses for at least 30 days before screening. All other long-term medications must be stable for at least 30 days, and rehabilitation methods stable for at least 15 days.
Main exclusion criteria: People not experiencing muscle stiffness, not within the specified age range, without chronic spinal cord injury, or part of a vulnerable population cannot participate.
Treatment focus: The two-step trial first determines the Minimal Effective Dose of Riluzole that improves muscle stiffness over two weeks, then evaluates this dose’s efficacy against placebo in a double-blind trial. Participants take capsules orally daily with regular assessments including spasticity scores, pain evaluations, pharmacokinetic blood sampling, and electrophysiological tests measuring nerve and muscle activity. The trial concludes in May 2025.
Investigational drugs: Riluzole is studied as an oral medication that may improve muscle stiffness in chronic spinal cord injury. It works by modulating glutamate neurotransmission, believed to reduce nerve signal overactivity leading to muscle stiffness.
Study on the Effectiveness and Safety of NT 201 for Treating Lower Limb Spasticity in Children and Adolescents with Cerebral Palsy
This prospective, randomized, double-blind trial studies NT 201 (IncobotulinumtoxinA) for treating leg muscle stiffness in children and adolescents with cerebral palsy. The study compares a single injection of NT 201 to placebo with an open-label extension period.
Main inclusion criteria: Children and teenagers between 2 and 17 years old with bilateral, symmetrical pes equinus (both feet pointing downwards) due to lower limb muscle stiffness caused by cerebral palsy can participate. They can have any level of movement ability and must have a Modified Ashworth Scale score of 2 or higher measuring calf muscle tightness when the foot is neutral and knee fully straightened. For the Open-Label Extension Period, participants need a score of 1 or higher in both feet, with agreement from investigator, parents, and participant (if able) to continue treatment.
Main exclusion criteria: Children and adolescents without lower limb muscle stiffness caused by cerebral palsy, children younger than 2 years old, and individuals not part of the vulnerable population selected for the study cannot participate.
Treatment focus: The study involves initial assessment using the modified Ashworth Scale, followed by a single intramuscular injection of XEOMIN or placebo. Control visits at weeks 4 and 6 reassess the muscle stiffness score. Primary evaluation observes changes from baseline at weeks 4 and 6, with secondary evaluations including Global Impression of Change Scale and Goal Attainment Scaling. Eligible participants may enter an open-label extension period for continued treatment.
Investigational drugs: NT 201 is administered as an injection to reduce muscle stiffness and improve leg movement. It works by blocking nerve signals causing muscle contraction, classified as a neuromuscular blocking agent.
Summary
The seven ongoing clinical trials for muscle spasticity demonstrate a concentrated focus on botulinum toxin treatments, with six of the seven studies investigating various formulations including IncobotulinumtoxinA, Botulinum Toxin Type A, IPN10200, and NT 201. Only one trial explores an alternative medication, Riluzole, for spinal cord injury-related spasticity.
Geographically, Spain shows the highest research activity with three trials, followed by Poland with two trials. Belgium, Austria, Bulgaria, Czechia, France, Germany, Hungary, Italy, and Latvia each host one or two trials, indicating widespread European research interest in this condition.
The trials address diverse patient populations, with two studies specifically focusing on children and adolescents with cerebral palsy, four targeting adult stroke or brain injury survivors, and one examining chronic spinal cord injury patients. Treatment approaches range from comparing botulinum toxin injections with dry needling to dose-finding studies and efficacy evaluations against placebo.
Most studies employ rigorous double-blind, randomized designs with observation periods typically lasting 12 to 20 weeks, though some extend up to 60 weeks with multiple injection cycles. Several trials include open-label extension periods to assess long-term safety and effectiveness. The research collectively aims to optimize dosing strategies, improve understanding of treatment mechanisms, and ultimately enhance quality of life for patients experiencing muscle stiffness across various underlying conditions.
