EUCTR2005-004834-42-CZActive, not recruitingNot Applicable
A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study ofPulmonary Function in Patients with Reduced Lung Function Treated with BOTOX®(Botulinum Toxin Type A) Purified Neurotoxin Complex for Focal Upper LimbSpasticity Due to Upper Motor Neuron Syndrome
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Allergan
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •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
Investigators
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