Clinical trial NCT01915459: Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Spasticity
Keywords: Stroke
Spasticity
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 186
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: The change in MAS(Modified Ashworth Scale) grade
timeFrame: from baseline at week 4
Secondary outcomes:
measure: The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor
timeFrame: from baseline at week 4
measure: The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor
timeFrame: from baseline at week 8 and 12
measure: The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target
timeFrame: from baseline at week 4, 8, 12
measure: Global assessment evaluated by investigator
timeFrame: at week 4, 8, 12
measure: Global assessment evaluated by patients
timeFrame: at week 4, 8, 12
measure: The change in carer burden on Caregiver Burden Scale evaluated by caregiver
timeFrame: from baseline at week 4, 8, 12
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Hospital
state: Kyunggi
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Asan Medical Center
name: Min-ho Chun, Ph.D.
role: STUDY_CHAIR
References: