Active — Not RecruitingPhase 3

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

United States603 participantsStarted 2019-09-16

Plain-language summary

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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: * Activated partial thromboplastin time \[aPTT\] ≤ 80 seconds (subjects on dabigatran or other direct thrombin inhibitors) or * International normalized ratio \[INR\] value of ≤ 2.5 (subjects on coumarins or other anticoagulants monitored by INR) Exclusion Criteria: * 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 * Bilateral lower limb paresis/paralysis/spasticity or tetraparesis/paralysis/spasticity * Body weight \< 50 kg * Severe atrophy of the target limb muscles * Previous, ongoin…

What they're measuring

Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6

Timeframe: Baseline to week 4-6

Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6

Timeframe: Week 4-6

Occurrence of treatment emergent adverse events [TEAEs] in the Main Period

Timeframe: Baseline to week 12

Trial details

NCT IDNCT03992404

SponsorMerz Pharmaceuticals GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury trials