EUCTR2018-001639-35-IT
Active, not recruiting
Phase 1
Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment - PATTERN (Multi-PAttern TreaTment of uppEr and loweR limb with iNcobotulinumtoxinA)
ConditionsDiagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injuryMedDRA version: 20.0Level: LLTClassification code 10058977Term: Spastic paresisSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsXeomin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
- Sponsor
- Merz Pharmaceuticals GmbH
- Enrollment
- 600
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Main 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:
- •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)
Exclusion Criteria
- •Main 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:
- •o Surgical intervention
- •o Alcohol or phenol block
- •o Muscle afferent block
Outcomes
Primary Outcomes
Not specified
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