Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Stroke Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02145689
• Other study ID #: 191622-129
• Secondary ID: 2013-002327-42
• Status: Withdrawn
• Phase: Phase 3
• First received: May 21, 2014
• Last updated: August 12, 2014
• Start date: August 2014
• Est. completion date: May 2017

Study information

• Verified date: August 2014
• 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 long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• For patients entering from the 191622-127 study, successful completion of study 191622-127

• For patients entering directly into study 191622-129, 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
Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale		Baseline, Up to 60 Weeks	No
Secondary	Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale		Baseline, Up to 60 Weeks	No
Secondary	Change from Baseline in Pain on an 11-Point Scale		Baseline, Up to 60 Weeks	No
Secondary	Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score		Baseline, Up to 60 Weeks	No