Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity

Sponsor

Hugel (Industry)

Overall Status

Completed

CT.gov ID

NCT01915459

Collaborator

(none)

186

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Spasticity	Biological: Botulinum toxin type A(Botulax®) Biological: Botulinum toxin type A(Botox®)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum toxin type A(Botulax®) Botulinum toxin type A	Biological: Botulinum toxin type A(Botulax®) IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone
Active Comparator: Botulinum toxin type A(Botox®) Botulinum toxin type A	Biological: Botulinum toxin type A(Botox®)

Arm

Intervention/Treatment

Experimental: Botulinum toxin type A(Botulax®)

Botulinum toxin type A

Biological: Botulinum toxin type A(Botulax®)

IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone

Active Comparator: Botulinum toxin type A(Botox®)

Botulinum toxin type A

Biological: Botulinum toxin type A(Botox®)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target [from baseline at week 4, 8, 12]
Global assessment evaluated by investigator [at week 4, 8, 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Patients with a known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
Patients who have participated in other clinical trials 1 month prior to this study
Male and Female who are not willing to take any appropriate means of contraception or to have ascetic life at least 2 months after treatment
Patients who are not eligible for this study at the discretion of the investigator

Contacts and Locations

Locations

	Site	City	State	Country
1	Seoul National University Hospital	Bundang	Kyunggi	Korea, Republic of
2	The Catholic University of Korea Incheon St. Mary's hospital	Incheon		Korea, Republic of
3	Asan Medical Center	Seoul		Korea, Republic of
4	Chung Ang University Hospital	Seoul		Korea, Republic of
5	Gangnam Severance Hospital	Seoul		Korea, Republic of
6	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of