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Completed

NCT Number: NCT01915459

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Catholic University of Korea Incheon St. Mary's hospital, Incheon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Botulinum toxin type A(Botulax®)

Biological

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®)

Biological

Primary outcomes

  1. The change in MAS(Modified Ashworth Scale) grade

    Time frame: from baseline at week 4

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

Secondary outcomes

  1. The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor

    Time frame: from baseline at week 4

  2. The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor

    Time frame: from baseline at week 8 and 12

  3. The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target

    Time frame: from baseline at week 4, 8, 12

  4. Global assessment evaluated by investigator

    Time frame: at week 4, 8, 12

  5. Global assessment evaluated by patients

    Time frame: at week 4, 8, 12

  6. The change in carer burden on Caregiver Burden Scale evaluated by caregiver

    Time frame: from baseline at week 4, 8, 12

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2013
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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