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
- Focal upper limb spasticity due to upper motor neuron syndromeincluding poststroke spasticity. (for the objective of this study patients must also have stable compromised baseline respiratory status)MedDRA version: 8.1Level: PTClassification code 10028335
- Registration Number
- EUCTR2005-004834-42-HU
- Lead Sponsor
- Allergan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method