Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Indianapolis, Indiana


Purpose:

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


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


Study is Available At:


Original ID:

191622-056


NCT ID:

NCT00651729


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

279


Enrollment Type:

Actual


Overall Contact Information

Official Name:Medical Director
Study Director
Allergan

Study Dates

Start Date:April 2003
Completion Date:December 2004
Completion Type:Actual
Primary Completion Date:December 2004
Primary Completion Type:Actual
Verification Date:May 2008
Last Changed Date:May 23, 2008
First Received Date:April 1, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Spasticity as measured by the Ashworth scale
Time Frame:Week 54
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Adverse events
Time Frame:Week 54
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:Botulinum Toxin Type A
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
Arm Name:1
Other Name:BOTOX®

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Botulinum Toxin Type A

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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
Reference Type:Reference
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.
Reference Type:Reference
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
Reference Type:Reference
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
Reference Type:Reference
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.
Reference Type:Reference
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
Reference Type:Reference
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.
Reference Type:Reference
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
Reference Type:Reference
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
Reference Type:Reference
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
Reference Type:Reference
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
Reference Type:Reference
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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.