Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00076687

Purpose

The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Condition	Intervention	Phase
Stroke Muscle Spasticity Motor Neuron Disease	Biological: botulinum toxin Type A Drug: saline	Phase II

MedlinePlus related topics: Botox

Drug Information available for: Sodium chloride Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Forced expiratory volume [ Time Frame: Week 12 - 30 ] [ Designated as safety issue: Yes ]
Forced vital capacity [ Time Frame: Week 12- 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Spasticity of affected flexor muscles (Ashworth scale) [ Time Frame: Baseline to Week 30 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
2: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
3: Placebo Comparator	Drug: saline Saline injection at Day 1, Week 12, Week 18

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- Abnormal pulmonary function test results; focal, upper limb spasticity, upper motor neuron syndrome

Exclusion Criteria:

- Previous exposure to botulinum toxin of any serotype

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076687

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

United States, Florida
	Recruiting
Miami, Florida, United States
Czech Republic
	Recruiting
Prague, Czech Republic
Hungary
	Recruiting
Szeged, Hungary
Poland
	Enrolling by invitation
Warsaw, Poland

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-057
Study First Received:	January 29, 2004
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00076687
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Degenerative motor system disease
Neurodegenerative Diseases
Brain Diseases
Motor neuron disease
Cerebrovascular Disorders
Signs and Symptoms

Muscle Spasticity
Botulinum Toxins
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Botulinum Toxin Type A
Motor Neuron Disease

Additional relevant MeSH terms:

Neuromuscular Manifestations
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Neuromuscular Agents
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009