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

Phase 3

Completed

• Conditions: Stroke; Spasticity
• Interventions: Biological: Botulinum toxin type A(Botulax®); Biological: Botulinum toxin type A(Botox®)

• Registration Number: NCT01915459
• Lead Sponsor: Hugel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Primary Completion: 2014-05
• Study Completion: 2014-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A(Botulax®)	Botulinum toxin type A(Botulax®)	Botulinum toxin type A
Botulinum toxin type A(Botox®)	Botulinum toxin type A(Botox®)	Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
The change in MAS(Modified Ashworth Scale) grade	from baseline at week 4	The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone

Secondary Outcome Measures

Name	Time	Method
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
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
Global assessment evaluated by investigator	at week 4, 8, 12
The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target	from baseline at week 4, 8, 12

Trial Locations

Locations (6)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea Incheon St. Mary's hospital; 🇰🇷 Incheon, Korea, Republic of

Chung Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Bundang, Kyunggi, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of