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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915459
• Other study ID #: HG-13-01
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2013
• Last updated: April 30, 2015
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity
• Stroke

Intervention

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
• Botulinum toxin type A(Botox®)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor		from baseline at week 4	No
Secondary	The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor		from baseline at week 8 and 12	No
Secondary	The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target		from baseline at week 4, 8, 12	No
Secondary	Global assessment evaluated by investigator		at week 4, 8, 12	No
Secondary	Global assessment evaluated by patients		at week 4, 8, 12	No
Secondary	The change in carer burden on Caregiver Burden Scale evaluated by caregiver		from baseline at week 4, 8, 12	No