Focal upper limb spasticity due to upper motor neuron syndrome including poststroke spasticity. (for the objective of this study patients must also have stable compromised baseline respiratory status) MedDRA version: 8.1 Level: PT Classification code 10028335
Conditions
Interventions
Trade Name: BOTOX
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum Toxin Type A
Concentration type: equal
Concentration number: 100-
Pharmaceut
Sponsors
Allergan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years of age or older 2. Written informed consent 3. Written Authorization for Use and Release of Health and Research Study Information has been obtained. 4. Medically stable subjects with stable compromised baseline respiratory status who have spastic muscles in at least the upper limb that manifests as common spasticity induced patterns of the upper motor neuron syndrome 5. History of upper motor neuron syndrome that results in upper limb spasticity of one or both upper limbs (spasticity in lower limb is allowed but will not be treated with study medication) 6. In the opinion of the investigator, the subject has sufficient spasticity in an affected upper limb, to be designated as the study limb, to warrant a dose of 360 U of BOTOX® 7. Stable pulmonary condition defined as no history of acute pulmonary complications within the past 4 months (e.g. hospitalization for exacerbation of chronic obstructive pulmonary disease, pneumonia, obvious reactive airway disease diagnosed by signs and symptoms, abnormal chest x-ray readings, etc.) 8. The largest FEV1 must be 40% to 80% of the predicted value at Visit 1 and Visit 2, and the largest FEV1 value at Visit 2 must not vary more than 20% of the largest value at Visit 1 9. The largest FVC value at Visit 2 must not vary more than 20% of the largest FVC value at Visit 1 10. Ability to perform acceptable and reproducible FEV1 and FVC according to 1995 ATS spirometry guidelines 11. Ability to follow study instructions and likely to complete all required visits 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. Stroke within 6 months of Visit 2 2. Known allergy or sensitivity to the study medication or its components 3. Previous therapy with BOTOX or any other botulinum toxin for any condition 4. Females who are pregnant, nursing, or planning a pregnancy during the study, or females of childbearing potential, not using a reliable means of contraception 5. Subjects with multiple sclerosis or primary lateral sclerosis where progression of the disease may confound study results 6. Any medical condition that may put the subject at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton- Lambert Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular transmission 7. More than one overnight hospitalization or 2 emergency room visits for respiratory related event(s) in the last 12 months 8. Infection or dermatological condition at anticipated injection sites 9. Current treatment with an intrathecal baclofen pump 10. Changes in corticosteroid medication dose/regimen in the last 2 months 11. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study 12. Subject has a condition or is in a situation which in investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pulmonary function safety of patients with stable compromised baseline respiratory status who receive repeat treatments of BOTOX® for focal upper limb spasticity.;Secondary Objective: ;Primary end point(s): The pulmonary function test (PFT) assessments FEV1, FVC (both observed and percent predicted values), and the derived variable FEV1/FVC are the primary assessments for this study. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed