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Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

Primary Purpose

Stroke, Muscle Spasticity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Botulinum Toxin Type A

Placebo

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Medically stable poststroke with focal unilateral upper-limb spasticity

Exclusion Criteria:

Stroke within 6 months of the study enrollment visit
Previous or current botulinum toxin therapy of any type in the study limb

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Botulinum Toxin Type A

Saline

Outcomes

Primary Outcome Measures

Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)

Secondary Outcome Measures

Spasticity of the upper-limb flexors as measured by the Ashworth Scale

Full Information

NCT ID

NCT00651690

First Posted

April 1, 2008

Last Updated

May 23, 2008

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00651690

Brief Title

Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Allergan

4. Oversight

5. Study Description

Brief Summary

This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Muscle Spasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Botulinum Toxin Type A

Arm Title

Arm Type

Placebo Comparator

Arm Description

Saline

Intervention Type

Biological

Intervention Name(s)

Botulinum Toxin Type A

Other Intervention Name(s)

BOTOX®

Intervention Description

200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Saline injection on Day 0

Primary Outcome Measure Information:

Title

Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Spasticity of the upper-limb flexors as measured by the Ashworth Scale

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medically stable poststroke with focal unilateral upper-limb spasticity Exclusion Criteria: Stroke within 6 months of the study enrollment visit Previous or current botulinum toxin therapy of any type in the study limb

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

Indianapolis

State/Province

Indiana

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16731213

Citation

Turkel CC, Bowen B, Liu J, Brin MF. Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity. Arch Phys Med Rehabil. 2006 Jun;87(6):786-92. doi: 10.1016/j.apmr.2006.02.015.

Results Reference

background

Citation

Turkel C, Bowen B, Liu J, Brin M. A pooled analysis of the safety of BoNTA (BOTOX(R)) in the treatment of poststroke spasticity. Neurorehabil Neural Repair 2006;20(1):200 ABS-P3-081

Results Reference

background

Links:

URL

http://www.allerganclinicaltrials.com

Description

Link to Clinical Trial Results

Learn more about this trial

Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

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