Prospective, randomized, observer-blind, parallel-group, multi-center trial to assess efficacy and safety of two different dilutions of NT 201 in patients with upper limb spasticity - NT-SPI
- Conditions
- Chronic upper limb spasticity caused by diverse etiologiesMedDRA version: 9.1Level: LLTClassification code 10028335Term: Muscle spasticity
- Registration Number
- EUCTR2006-003036-30-IT
- Lead Sponsor
- MERZ PHARMACEUTICALS GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
? Female or male patients >= 18 years
? Stable upper limb spasticity of diverse etiology: >= 6 months after stroke, brain injury or spinal cord injury or multiple sclerosis with no relapse within 3 month prior to screening visit or cerebral palsy
? Focal spasticity with >= 2 points on the Ashworth scale in the wrist flexors (incl. clinical pattern of flexed wrist) or wrist (incl. clinical pattern of flexed wrist) and elbow flexors (incl. clinical pattern of flexed elbow)
? Disability Assessment Scale [DAS] score >= 2 for principle therapeutic target
? For pre-treated patients only:
source documentation of the most recent injection session with botulinum toxin and sufficient therapeutic response for flexed wrist or flexed wrist and elbow
? For pre-treated patients only:
Total dose of most recent injection with botulinum toxin must have been not more than of 400 units BOTOX (1600 units Dysport or 16.000 units Neurobloc (type B)) for the affected flexors of wrist or affected flexors of wrist and elbow. For flexor carpi ulnaris, the maximal dose must have been not more than 50 units BOTOX (200 units Dysport or 2000 units Neurobloc), for flexor carpi radialis, the maximal dose must have been not more than 60 units BOTOX (240 units Dysport or 2400 units Neurobloc).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? Previous treatment with botulinum toxin of any serotype during the last 4 months prior to screening visit
? Change in co-medication with centrally acting muscle relaxants (including benzodiazepines) within the 4
weeks prior to screening and/or co-medication with centrally acting muscle relaxants which dose cannot be kept constant during the trial
? Change in antidepressive medication within the 8 weeks prior to screening visit and/or antidepressive medication which dose cannot be kept constant during the trial
? Change in physical or occupational therapy regimens or in any other rehabilitation treatment of spasticity (including splinting) within the 4 weeks prior to screening and/or physical or occupational therapy or any other rehabilitation treatment of spasticity that cannot be kept constant during the trial
? Treatment with intrathecal baclofen within 4 weeks prior to screening visit
? Planned surgery of the target limb
? Surgical treatment in the target limb for any indication within 8 weeks prior to screening visit
? Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A
? Treatment with non-authorized concomitant medication
? Severe atrophy of target limb muscles
? Infection in the area of the planned injection points
? Anticoagulation therapy which requires an INR value of> 2.5
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy and safety of two different dilutions of NT 201 (50 units/mL or 20 units/mL) in patients with chronic upper limb spasticity.;Secondary Objective: n.a.;Primary end point(s): DAS response rate over time
- Secondary Outcome Measures
Name Time Method