Spasticity and Associated Focal Spasticity MedDRA version: 9.1 Level: LLT Classification code 10041416 Term: Spasticity
Conditions
Interventions
Trade Name: BOTOX®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Sponsors
Allergan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients between 18 and 85 years of age 2.Patients with stroke due to a primary cerebral haemorrhage/ infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia 3.Patients suitable for botulinum toxin type A (BOTOX®) 4.Patients with documented focal/multifocal problems of spasticity in the upper and/or lower limbs and for who functional gains are anticipated after treatment with BOTOX® + SC •Patients treated for upper limb spasticity: evidence of preserved antagonist function and at least one item of the REsistance to PAssive movement Scale (REPAS) with a score of at least 1 at the relevant joint(s) for the primary endpoint •Patients treated for lower limb spasticity: evidence of preserved standing/ambulation function and at least one item of the REPAS with a score of at least 1 at the relevant joint(s) for the primary endpoint 5.Patients with spasticity, as defined in criterion #4 above, caused by a stroke that happened 3 months or more before the Screening visit 6.Female patients either surgically sterile (has had tubal ligation, documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test is negative and agree to use birth control (e.g. hormonal contraception [estrogen or progesterone agents], intrauterine contraceptive device, double barrier methods [condom with spermicide, diaphragm with spermicide, or male condom and diaphragm], or total sexual abstinence) during the study 7.Patients able to communicate effectively, with the help of a third person completing answers on their behalf (when required) 8.Patients willing and able to come to each study protocol visit and answer questions by phone on a monthly basis, possibly with the assistance of a caregiver 9.Patients willing and able to provide a signed and dated written informed consent 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: 1.Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated 2.Patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.) 3.Patients who have been previously treated with botulinum toxin or phenol nerve block in the limbs to be injected during this trial 4.Patients requiring concomitant use of intrathecal baclofen or phenol nerve block at any point during the study; patients requiring systemic aminoglycoside antibiotics or spectinomycin during the period from at least 3 days before until 6 weeks after injection of study medication. 5.Patients who are currently taking part in any other clinical trial or have taken part in a clinical trial of a new chemical entity within 6 months prior to Screening 6.Patients with a Mini-Mental State Examination (MMSE) 40 8.Patients with known medical conditions (e.g. cardiac condition, cancer, etc.) that would affect their ability to benefit from treatment or to complete the study 9.Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin) 10.Patients with myasthenia gravis or Eaton Lambert Syndrome 11.Patients with infection at the proposed injection site(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of BOTOX® + Standard of Care (SC) versus placebo + SC for the treatment of adult post-stroke focal spasticity as measured by the number of patients in each arm who achieve their principal functional goal as determined by the physician.; Secondary Objective: •To evaluate the effectiveness of BOTOX® + SC versus placebo + SC for the treatment of adult post-stroke focal spasticity; - as measured by the number of patients in each arm who achieve their functional goal as determined by the patient. - and as measured by the level of functional goal as determined by the patient. •Time to reach functional goal attainment as determined by the physician and patient. •To evaluate and compare improvement in patient’s quality of life when treated with BOTOX® + SC versus placebo + SC. •To collect resource use data from actual clinical practice in the treatment of patients in rehabilitation centres and specialised centres. •To evaluate and compare level of resource use of patients on BOTOX® + SC versus placebo + SC. •To evaluate and compare the cost, cost-effectiveness and cost-utility of BOTOX® + SC versus placebo + SC. •To identify drivers of use of resources and cost. •Occurrence of adverse events (AEs) during the study. ; Primary end point(s): •comparison of the number of patients in each of the two treatment arms who achieve their principal active functioning goal (i.e. a score of 0 to +2 inclusive), as determined by the physician, at 10 weeks after the second injection (between 22 and 34 weeks) or at 24-week visit or at time of withdrawal if no second injection has been conducted Goal attainment will be measured using the following 6-point Likert scale: Score Outcome -3 Worse than start | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed