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Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

Primary Purpose

Stroke, Muscle Spasticity

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Botulinum Toxin Type A

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

Medically stable poststroke patients with spastic muscles in the upper limb

Exclusion Criteria:

Stroke within 6 months of study enrollment
Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Botulinum Toxin Type A

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Spasticity as measured by the Ashworth scale

Full Information

NCT ID

NCT00651729

First Posted

April 1, 2008

Last Updated

May 23, 2008

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00651729

Brief Title

Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Allergan

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety of repeated doses of Botulinum Toxin Type A for the treatment of focal upper limb poststroke spasticity

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Botulinum Toxin Type A

Intervention Type

Biological

Intervention Name(s)

Botulinum Toxin Type A

Other Intervention Name(s)

BOTOX®

Intervention Description

Each patient received from 1 to 5 treatments, with a minimum of 12 weeks between treatments. For each treatment, a total dose of 200 U to 400 U botulinum toxin Type A was injected into the wrist and finger flexor muscles of the affected upper limb, not to exceed 6 U/kg

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

Week 54

Secondary Outcome Measure Information:

Title

Spasticity as measured by the Ashworth scale

Time Frame

Week 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medically stable poststroke patients with spastic muscles in the upper limb Exclusion Criteria: Stroke within 6 months of study enrollment Previous therapy with Botulinum Toxin Type A for treatment of any condition prior to 4 months of enrollment, for treatment of any condition prior to 01 January 1998

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

City

Vancouver

State/Province

British Columbia

Country

Canada

12. IPD Sharing Statement

Citations:

Citation

Elovic EP, Barron RL, Liu J, Turkel CC. Resource utilization, productivity, and caregiver burden impact in a trial of repeated doses of botulinum toxin type A for the treatment of focal upper-limb poststroke spasticity: A multicenter open-label study. Arch Phys Med Rehabil 2005;86(9):E46 ABS-Poster 239

Results Reference

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Citation

Elovic EP, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel CC. Safety and efficacy of repeated botulinum toxin type A treatments for focal upper-limb poststroke spasticity: Results of a 12-month multicenter, open-label trial. Arch Phys Med Rehabil 2005,86(9):E46-7 ABS-Poster 242.

Results Reference

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Citation

Mayer N, Barron RL, Liu J, Turkel CC. The burden of illness associated with loss of function after stroke in patients with arm spasticity enrolled in a multicenter open-label study. Arch Phys Med Rehabil 2005;86(9):E47 ABS-Poster 243

Results Reference

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Citation

Childers MK, Barron RL, Patel RK, Turkel CC. Health utility and quality of life following botulinum toxin type A in repeated doses for the treatment of focal upper-limb spasticity in stroke patients: A multicenter open-label study. Arch Phys Med Rehabil 2005;86(9):E48 ABS-Poster 249

Results Reference

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Citation

Mayer N, Barron R, Liu J, Turkel C. The burden of illness associated with loss of function after stroke in patients with arm spasticity enrolled in a multicenter open-label study. Arch Phys Med Rehabil 2006 Oct;87(10):E46-7 POS-Poster 54.

Results Reference

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Citation

Elovic E, Kaelin D, Brashear A, McIntosh R, Liu J, Barron R. Safety and efficacy of repeated botulinum toxin type A for focal upper-limb poststroke spasticity in patients aged 65 and older in a 12-month multicenter open-label trial. Arch Phys Med Rehabil 2006 Oct;87(11):E50 ABS-PR_272

Results Reference

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Citation

Elovic E, rashear A, Kaelin D, Abu-shakra S, VanDenburgh A, Turkel CC, Beddingfield III F. The effect of repeated treatment of botulinum toxin type A on poststroke, spasticity-related pain: A subgroup analysis of patients in a 12-month trial. Arch Phys Med Rehabil 2007 Sep;88(10):E4 ABS-Article 13.

Results Reference

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Citation

Elovic E, Brashear A, Kaelin D, Liu J, VanDenburgh AM, Beddingfield III F. The effect of repeated treatment of botulinum toxin type A on poststroke, spasticity-related pain: A subgroup analysis of patients in a 12-month trial. Arch Phys Med Rehabil 2007 Sep;88(9):E65 ABS-Poster 195

Results Reference

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Citation

Childers MK, Barron RL, Patel RK, Turkel CC. A multi-center open label study of botulinum toxin type A (BoNT/A) treatment of focal upper limb post-stroke spasticity: Health utility and quality of life assessment. Can Assoc Phys Med & Rehabil Annual Meeting 2006;(Online):ABS-CL-47

Results Reference

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Citation

Elovic E, Barron RL, Lui J, Turkel CC. Repeated doses of botulinum toxin type A (BoNT/A) for the treatment of post-stroke focal upper limb spasticity: Assessments of resource utilization, caregiver burden, and productivity. Can Assoc Phys Med & Rehabil Annual Meeting 2006;(Online):ABS-CL-49

Results Reference

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Citation

Elovic E, Brashear A, Kaelin D, McIntosh R, Lui J, Turkel C. Assessment of safety and efficacy of multiple botulinum toxin type A (BoTN/A) injections for post-stroke focal upper limb spasticity: A one year-long multicenter, open-label trial. Can Assoc Phys Med & Rehabil Annual Meeting 2006;(Online):ABS-CL-51

Results Reference

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Citation

Elovic E, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel CC. Safety and efficacy of repeated botulinum toxin type A (BoNTA) in the treatment of poststroke, upper limb spasticity: A 12-month trial. Mov Disord 2006;21(Suppl 15):S423 ABS-P347

Results Reference

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Citation

Elovic E, Brashear A, Kaelin D, McIntosh R, Liu JY, Barron R, Turkel C. Safety and efficacy of repeated botulinum toxin type A for focal upper limb poststroke spasticity in patients aged 65 years and older in a 12-month multicenter open-label trial. Neurology 2006 14 Mar;66(5 Suppl 2):A297-8 ABS-P05.156

Results Reference

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Citation

Slavic E, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel C. The effect of repeated treatment of botulinum toxin type A on poststroke, spasticity-related pain: A subgroup analysis of patients in a 12-month trial. Neurology 2007;68(12 Suppl 1):A177 ABS-P04.131

Results Reference

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Citation

Elovic E, Brashear A, Kaelin D, McIntosh R, Liu J, Turkel C. Safety and efficacy of repeated botulinum toxin type A treatments for focal upper limb poststroke spasticity: Results of a 12-month multicenter, open-label trial. Neurotox Res 2006 Apr;9(2-3):230 ABS-P23

Results Reference

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Links:

URL

http://www.allerganclinicaltrials.com

Description

Link to Clinical Trial Results

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Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity

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