Clinical trial NCT00651729: Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 279
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Adverse events
timeFrame: Week 54
Secondary outcomes:
measure: Spasticity as measured by the Ashworth scale
timeFrame: Week 54
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
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
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.
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
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
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.
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
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.
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
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
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
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
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
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
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
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