E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic upper limb spasticity caused by diverse etiologies |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028335 |
E.1.2 | Term | Muscle spasticity |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
ユ Female or male patients >= 18 years
ユ 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
ユ 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)
ユ Disability Assessment Scale [DAS] score >= 2 for principle therapeutic target
ユ 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
ユ 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). |
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E.4 | Principal exclusion criteria |
ユ Previous treatment with botulinum toxin of any serotype during the last 4 months prior to screening visit
ユ 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
ユ 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
ユ 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
ユ Treatment with intrathecal baclofen within 4 weeks prior to screening visit
ユ Planned surgery of the target limb
ユ Surgical treatment in the target limb for any indication within 8 weeks prior to screening visit
ユ Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A
ユ Treatment with non-authorized concomitant medication
ユ Severe atrophy of target limb muscles
ユ Infection in the area of the planned injection points
ユ Anticoagulation therapy which requires an INR value of> 2.5 |
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E.5 End points |
E.5.1 | Primary end point(s) |
DAS response rate over time |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso dosaggio, altra diluizione |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |