Post-stroke spasticity of the upper limb MedDRA version: 8.1 Level: LLT Classification code 10028335 Term: Muscle spasticity
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: NT101
Other descriptive
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -willingness of the patient to participate as documented by written informed consent. -female or male patients at least 18 years -at least 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g. neurologist) - focal spasticity with at least 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist. -focal spasticity with at least 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist - Disability Assessment Scale at least 2 points in a principal target domain - for pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist - for pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX or 200 Units Dysport or 2000 Units Neurobloc (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficalis, digitorum profundus -for pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX or 240 Units Dysport or 2400 Units Neurobloc (type B preparation) for flexor carpi radialis -negative blood and urine pregnancy test at trial entry for females 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: -spasticity of any other origin than stroke -previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7) -planned concomitant treatment with Botulinum Toxin of any serotype and for any body region -previous or planned treatment with phenol- or alcohol-injection in the target limb -previous surgical treatment of spasticity in the target muscle(s) -fixed contracture, defined as severe restriction of the range of joint movement on passive stretch -severe atrophy of the target limb muscles -bilateral upper limb paresis/paralysis --surgical treatment in the target limb for any indication within the 8 weeks prior to Screening (Visit 1, Day-7) -planned surgery in the target limb -planned elective surgery under general anesthesia during the Main Period -hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin type A -change in antispastic medication with centrally acting muscle relaxants (including benzodiazepines) within the 2 weeks prior to Screening (Visit 1, Day -7) and /or antispastic medication with centrally acting muscle relaxants that is intended to be changed during the Main Period. -antispastic medication with peripheral muscle relaxants (including dantrolene) within the 2 weeks prior to Screening (Visit 1, Day -7) -change in antidepressant medication within the 4 weeks prior to Screening (Visit 1, Day -7) and/or antidepressant medication that is intended to be changed during the Main Period -change in physical or occupational therapy regimens (including splinting) within the 2 weeks prior to Screening (Visit 1, Day -7) and/or physical or occupational therapy that is intended to be changed during the Main Period. -treatment with intrathecal baclofen within 2 weeks prior to Screening (Visit 1, Day -7) -other non-authorized concomitant treatments -concomitant rheumatic disease in the target limb, which in the opinion of the Investigator would affect the therapeutic outcome of treatment with Botulinum Toxin -other muscle hypertonia (e.g rigidity) -current alcoholism or other drug abuse/dependence -diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study -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 -anticoagulation therapy which requires an International Normalized Ratio [INR] value of greater than 2.5 or Quick Value of less than 30% -INR value of greater than 2.5 on injection day -infection in the area of the planned injection points -nursing mothers -women of childbearing potential without reliable means of contraception (reliable contraception is hormonal contraception or barrier contraception combined with intrauterine contraceptive device) and women planning pregnancy during the course of the trial -in the judgement of the Investigator there is severe impairment of cognition that in the opinion of the Investigator does not enable the patient to fully understand the informed consent and participate in the trial -in the judgement of the Investigator there is severe impairment of communication (e.g. patients with significant aphasia) that in the opinion of the Investigator precludes the patient participating in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy and safety of NT 201 compared to placebo in the treatment of post-stroke spasticity of the upper limb and the influence of treatment on functional impairment and carer burden;Secondary Objective: ;Primary end point(s): Responder analysis at Control Visit V4 (Week 4) for patients with an improvement (reduction) of at least 1 ponit from Baseline Visit (V2, Day 0) in the Ashworth Score for wrist flexors. | — |
Countries
Czech Republic
Outcome results
None listed