Patients with acute cerebrovascular event showing signs of beginning upper limb spasticity MedDRA version: 9.0 Level: LLT Classification code 10041416
Conditions
Interventions
Trade Name: Xeomin
Product Name: Xeomin
Product Code: NT 201
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum A Toxin
Current Sponsor code: NT 101
Other descriptiv
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female or male patients aged =18 years - Acute cerebrovascular event (e.g. any kind of stroke or cerebral haemorrhage) - Necessity for rehabilitation measure - Newly developed focal spasticity in upper limb - Spasticity with = 1 point on the MAS in the wrist flexors or spasticity with =1 point on the MAS in the wrist flexors and elbow flexors - Start of injection of trial medication within 3 to 30 days after the event - Written informed consent obtained by patient or a witness in case the patient is unable to write - Negative urine pregnancy test at trial entry for women of childbearing potential 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
Exclusion criteria
Exclusion criteria: - Current or previous treatment with botulinum toxin of any serotype and for any body region - Severe aphasia resulting in inability of the patient to follow the consent procedure - Severe atrophy of the target limb muscles - Any rheumatic or orthopaedic disease of the affected limb - Planned surgery of the target limb - Surgical treatment in the target limb for any indication within 8 weeks prior to screening - Hypersensitivity to human serum albumin, sucrose or botulinum neurotoxin type A - Anticoagulation therapy which requires an INR > 2.5 - Treatment with intravenously administered heparin within 24 hours prior to first injection of trial medication - Infection in the area of the planned injection points or systemic infections presenting a hazard for local injections - Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the study - Use of non-authorised concomitant medication - Severe and/or unstable hypertension - Severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic or gastrointestinal), current malignancy or anamnestic HIV infection - Clinically relevant pathological findings in laboratory parameters, indicating active disease of vital organs - Nursing mothers and women of childbearing potential without reliable means of contraception (hormonal contraception or barrier contraception combined with intrauterine contraception device) and women planning pregnancy during the course of the trial - Participation in a clinical study within the last 1 month prior to screening - Previous randomisation in this clinical study - In the opinion of the investigator the patient is unlikely to complete all visits - Other contraindications which in the investigator’s opinion preclude participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of NT 201 versus placebo in the treatment of patients with beginning upper limb spasticity after acute cerebrovascular event in terms of change in MAS for wrist flexors from baseline to 48 weeks after baseline;Secondary Objective: The secondary objectives of the study are to asses the efficacy of NT 201 versus placebo in terms of: - Change in MAS for wrist flexors fro baseline over time - Change in MAS for elbow flexors ( if treated) from baseline over time - Change in ADL score from baseline over time - Change in DAS from baseline over time - Change in PROM for wrist from baseline over time - Change in pain intensity in the upper limb from baseline over time as assessed on the VAS - Physicians and patients global assessment of efficacy of treatment at week 48 As part of the safety evaluation during the study the incidence of adverse events, routine haematology and clinical chemistry values, ECG and the formation of neutralising botulinum toxin antibodies will be investigated. ;Primary end point(s): The primary efficacy endpoint is defined as the change in the MAS for wrist flexors from baseline to 48 weeks after baseline, compared between treatment groups. | — |
Countries
Germany
Outcome results
None listed