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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02145689

Enrollment

Registered

2014-05-23

Start date

2014-08-31

Completion date

2017-05-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity, Stroke

Brief summary

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

Interventions

BIOLOGICALonabotulinumtoxinA

Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale	Baseline, Up to 60 Weeks
Change from Baseline in Pain on an 11-Point Scale	Baseline, Up to 60 Weeks
Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score	Baseline, Up to 60 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026