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Study to compare the efficacy and safety of NT 201 (botulinum toxin) with placebo for the treatment of lower limb spasticity caused by stroke or traumatic brain injury.
EU CTIS ID: 2023-505810-12-00
What this study is testing
Evaluation of the efficacy and safety of 400 Units [U] of NT 201 in the treatment of adult lower limb spasticity involving the ankle plantar flexors
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female or male subject ≥ 18 years and ≤ 85 years at screening
- Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
- Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
- Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
- Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
- At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
You likely can't join if
- Generalized disorders of muscle activity (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
- Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
- Pregnancy (as verified by a positive pregnancy test) or breast feeding.
- Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
- Body weight < 50 kg
- Severe atrophy of the target limb muscles
See the full eligibility criteria
- Female or male subject ≥ 18 years and ≤ 85 years at screening
- Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
- Disabling ankle flexor spasticity presenting as pes equinus or pes equinovarus
- Modified Ashworth Scale-Bohannon [MAS] score of 2 or 3 points in the ankle plantar flexor of the target lower limb (supine position, knee extended)
- Minimum passive range of motion in ankle of the target lower limb (supine position, knee extended): 10°dorsiflexion and 20°plantarflexion
- At least 4 months since last botulinum neurotoxin [BoNT] injection for treatment of spasticity or any other condition
- For subjects receiving anticoagulation therapy, the investigator confirms and documents that the subject has an: o Activated partial thromboplastin time [aPTT] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or o International normalized ratio [INR] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR).
- Generalized disorders of muscle activity (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis) or any other significant peripheral neuromuscular dysfunction which might interfere with the study
- Subjects with presence or history of aspiration pneumonia, recurrent lower respiratory tract infections, or compromised respiratory function as per investigator's clinical judgment
- Pregnancy (as verified by a positive pregnancy test) or breast feeding.
- Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity
- Body weight < 50 kg
- Severe atrophy of the target limb muscles
- Previous, ongoing or planned treatments of spasticity with intrathecal baclofen
- Previous, ongoing, or planned treatments of spasticity in the target lower limb with any of the following procedures: o Surgical intervention o Alcohol or phenol block o Muscle afferent block
- Physiotherapy or use of orthoses or splints at the target limb initiated less than 4 weeks before screening or expected to change during the double-blind phase of the study
- Current or planned treatment with parenterally administered drugs that interfere with neuromuscular transmission (e.g., intrathecal baclofen, tubocurarine-type muscle relaxants used in anesthesia), or local anesthetics in the treated region within 2 weeks prior to screening
- Infection or inflammation at the injection sites
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- Switzerland
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; Switzerland; Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.