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

This study is ongoing, but not recruiting participants.

First Received: January 29, 2004 Last Updated: August 7, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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 ]

Enrollment:	155
Study Start Date:	October 2003
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 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

Locations

United States, Florida

Miami, Florida, United States
Czech Republic

Prague, Czech Republic
Hungary

Szeged, Hungary
Poland

Warsaw, Poland

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-057
Study First Received:	January 29, 2004
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00076687 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Physiological Effects of Drugs
Neuromuscular Agents
Brain Diseases
Neurodegenerative Diseases
Cerebrovascular Disorders
Signs and Symptoms
Musculoskeletal Diseases
Neuromuscular Diseases
Muscle Hypertonia
Therapeutic Uses
Cardiovascular Diseases
Botulinum Toxin Type A

Motor Neuron Disease
Neuromuscular Manifestations
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Pharmacologic Actions
Muscle Spasticity
Muscular Diseases
Botulinum Toxins
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010