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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    600
  • sponsor
    Merz Pharmaceuticals GmbH
Updated on 22 June 2021

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.

Details
Condition Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Treatment Placebo, NT 201
Clinical Study IdentifierNCT03992404
SponsorMerz Pharmaceuticals GmbH
Last Modified on22 June 2021

Eligibility

Yes No Not Sure

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): 10dorsiflexion and 20plantarflexion
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, 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: Surgical Intervention; Alcohol or phenol block; 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
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
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