Status:
COMPLETED
Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity
Lead Sponsor:
Hugel
Conditions:
Stroke
Spasticity
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01915459
Start Date
June 1 2013
End Date
July 1 2014
Last Update
May 4 2015
Active Locations (6)
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1
The Catholic University of Korea Incheon St. Mary's hospital
Incheon, Incheon, South Korea
2
Seoul National University Hospital
Bundang, Kyunggi, South Korea
3
Asan Medical Center
Seoul, Seoul, South Korea
4
Chung Ang University Hospital
Seoul, Seoul, South Korea