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

NCT ID: NCT01915459

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Stroke; Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Botulinum toxin type A(Botulax®)

Botulinum toxin type A

Group Type: EXPERIMENTAL

Botulinum toxin type A(Botulax®)

Intervention Type: BIOLOGICAL

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

Botulinum toxin type A(Botox®)

Botulinum toxin type A

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A(Botox®)

Intervention Type: BIOLOGICAL

Interventions

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

Intervention Type: BIOLOGICAL

Botulinum toxin type A(Botox®)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male and Female patients, over 20 years of age

2. Patients with a history of stroke more than 6weeks prior to enrollment

3. 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

4. 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)

5. 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

1. Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis

2. Patients with profound atrophy of the muscle in the target limb

3. Patients with fixed joint/muscle contracture* in the target limb

• Defined as inability to passively move the joints

4. Patients with history within 6 months or planned to have treatment with phenol or alcohol injection(chemodenervation) in the target limb

5. Patients with history within 6 months or planned to have treatment with tendon lengthening in the target limb

6. Patients who have concurrent treatment with an intrathecal baclofen

7. Patients who had received Botulinum toxin injection within the past 3 months(for cosmetic purpose is allowed)

8. 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)

9. 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

10. Patients with a known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)

11. Patients who have participated in other clinical trials 1 month prior to this study

12. 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

13. Patients who are not eligible for this study at the discretion of the investigator

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hugel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-ho Chun, Ph.D.

Role: STUDY_CHAIR

Asan Medical Center

Locations

The Catholic University of Korea Incheon St. Mary's hospital

Incheon, Incheon, South Korea

Seoul National University Hospital

Bundang, Kyunggi, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Chung Ang University Hospital

Seoul, Seoul, South Korea

Gangnam Severance Hospital

Seoul, Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

HG-13-01

Identifier Type: -

Identifier Source: org_study_id