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
1 other identifier
interventional
186
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 stroke
Started Jun 2013
Shorter than P25 for phase_3 stroke
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMay 4, 2015
April 1, 2015
11 months
August 1, 2013
April 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Botulinum toxin type A(Botulax®)
EXPERIMENTALBotulinum toxin type A
Botulinum toxin type A(Botox®)
ACTIVE COMPARATORBotulinum toxin type A
Interventions
IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hugellead
Study Sites (6)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Min-ho Chun, Ph.D.
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2013
First Posted
August 5, 2013
Study Start
June 1, 2013
Primary Completion
May 1, 2014
Study Completion
July 1, 2014
Last Updated
May 4, 2015
Record last verified: 2015-04