OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Stroke Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02145676
• Other study ID #: 191622-127
• Secondary ID: 2013-002346-37
• Status: Terminated
• Phase: Phase 3
• First received: May 21, 2014
• Last updated: January 30, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

• Spasticity in the non-study upper limb that requires treatment

• Presence of fixed contractures in of the study muscles in elbow or shoulder

• Profound atrophy of muscles to be injected

• Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months

• Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months

• Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month

• Condition other than stroke contributing to upper limb spasticity

• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Biological:
• onabotulinumtoxinA
OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.

Drug:
• placebo (normal saline)
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale		Baseline, Week 6	No
Secondary	Change from Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale		Baseline, Week 6	No
Secondary	Clinical Global Impression (CGI) Of Overall Change by Physician Compared to Baseline Using a 9-Point Scale		Baseline, Week 6	No
Secondary	Change from Baseline in Pain on an 11-Point Scale		Baseline, Week 6	No
Secondary	Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score		Baseline, Week 6	No

External Links

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