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

This study has been completed.

Study NCT00076687 Information provided by Allergan

First Received on January 29, 2004. Last Updated on August 30, 2011 History of Changes

Results First Received: July 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Stroke Muscle Spasticity Motor Neuron Disease
Interventions:	Biological: botulinum toxin Type A Drug: saline

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo
Botulinum Toxin Type A 240 U	botulinum toxin Type A 240 U
Botulinum Toxin Type A 360 U	botulinum toxin Type A 360 U

Participant Flow: Overall Study

	Placebo	Botulinum Toxin Type A 240 U	Botulinum Toxin Type A 360 U
STARTED	48	52	55
COMPLETED	42	47	51
NOT COMPLETED	6	5	4

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo
Botulinum Toxin Type A 240 U	botulinum toxin Type A 240 U
Botulinum Toxin Type A 360 U	botulinum toxin Type A 360 U

Baseline Measures

	Placebo	Botulinum Toxin Type A 240 U	Botulinum Toxin Type A 360 U	Total
Number of Participants [units: participants]	48	52	55	155
Age [units: years] Mean ( Full Range )	58 ( 18 to 80 )	55.5 ( 21 to 83 )	55.8 ( 19 to 81 )	56.4 ( 18 to 83 )
Gender [units: participants]
Female	19	13	21	53
Male	29	39	34	102

Outcome Measures

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1. Primary:

Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, Week 6 ]

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2. Primary:

Change From Baseline in Forced Expiratory Volume (FEV1) [ Time Frame: Baseline, Week 6 ]

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3. Secondary:

Change From Baseline in FEV1/FVC Ratio [ Time Frame: Baseline, Week 6 ]

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4. Secondary:

Change From Baseline in Ashworth Scale [ Time Frame: Baseline, Week 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00076687 History of Changes
Other Study ID Numbers:	191622-057
Study First Received:	January 29, 2004
Results First Received:	July 28, 2011
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration