A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity

Hugel6 sites in 1 country186 target enrollmentJune 2013

ConditionsStroke Spasticity

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Stroke
Sponsor: Hugel
Enrollment: 186
Locations: 6
Primary Endpoint: The change in MAS(Modified Ashworth Scale) grade
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to Botox® reducing upper limb muscle tone in post stroke patients.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hugel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and Female patients, over 20 years of age
•Patients with a history of stroke more than 6weeks prior to enrollment
•Focal spasticity of wrist flexor measured with Modified Ashworth Scale (MAS) of 2 or greater at wrist and 1 or greater at least one of elbow flexor and finger flexor
•A minimum grade of 2 or greater on the Disability Assessment Scale(DAS) for targeted one functional disability item (i.e., hygiene, dressing, pain, or limb position)
•Patients who signed informed consent form, clearly understand the intent of the study and are able to comply with instructions to complete the entire study

Exclusion Criteria

•Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
•Patients with profound atrophy of the muscle in the target limb
•Patients with fixed joint/muscle contracture\* in the target limb
•Defined as inability to passively move the joints
•Patients with history within 6 months or planned to have treatment with phenol or alcohol injection(chemodenervation) in the target limb
•Patients with history within 6 months or planned to have treatment with tendon lengthening in the target limb
•Patients who have concurrent treatment with an intrathecal baclofen
•Patients who had received Botulinum toxin injection within the past 3 months(for cosmetic purpose is allowed)
•Patients with concurrent or planned to take muscle relaxants and/or benzodiazepine medication (Allowed to participate if patient has consistently taken these medication from a month before screening visit and no changes in therapy are planned during the study)
•Patients with concurrent or planned to have physical, occupational, or splinting therapy (Allowed to participate if these therapies were consistently taken from a month before screening visit and no treatment changes are planned during the study

Outcomes

Primary Outcomes

The change in MAS(Modified Ashworth Scale) grade

Time Frame: from baseline at week 4

The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone

Secondary Outcomes

The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor(from baseline at week 4)
The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor(from baseline at week 8 and 12)
Global assessment evaluated by patients(at week 4, 8, 12)
The change in carer burden on Caregiver Burden Scale evaluated by caregiver(from baseline at week 4, 8, 12)
Global assessment evaluated by investigator(at week 4, 8, 12)
The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target(from baseline at week 4, 8, 12)