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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Spasticity
• Intervention / Treatment: Biological: Botulinum toxin type A(Botulax®); Biological: Botulinum toxin type A(Botox®)

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • The Catholic University of Korea Incheon St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of
    • Chung Ang University Hospital
  • Kyunggi
    • Bundang, Kyunggi, Korea, Republic of
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum toxin type A(Botox®); Botulinum toxin type A	Biological: Botulinum toxin type A(Botox®)
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hugel
• Investigators: Study Chair: Min-ho Chun, Ph.D., Asan Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): May 4, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Stroke; Spasticity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HG-13-01