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StrokePhase 3NCT01915459

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

A Phase 3 study testing Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®) in people with Stroke and Spasticity, run by Hugel at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke, Spasticity
What is being tested?
Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
6 sitesSouth Korea
Study dates
Jun 2013to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Seoul National University Hospital

    Bundang, Kyunggi

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

    Incheon, Incheon

  • Asan Medical Center

    Seoul, Seoul

  • Chung Ang University Hospital

    Seoul, Seoul

  • Gangnam Severance Hospital

    Seoul, Seoul

  • SMG-SNU Boramae Medical Center

    Seoul, Seoul

Other trials in South Korea

About this study

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

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.

Conditions
Stroke, Spasticity
Being tested
Botulinum toxin type A(Botulax®), Botulinum toxin type A(Botox®)
Keywords
Stroke, Spasticity
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT01915459
Study groupRoleWhat they receive
Botulinum toxin type A(Botulax®)ExperimentalBotulinum toxin type A
Receives: Biological: Botulinum toxin type A(Botulax®)
Botulinum toxin type A(Botox®)Active comparatorBotulinum toxin type A
Receives: Biological: Botulinum toxin type A(Botox®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from baseline at week 4

Secondary outcomes (6)

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

    Measured: from baseline at week 4

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

    Measured: from baseline at week 8 and 12

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

    Measured: from baseline at week 4, 8, 12

  4. Global assessment evaluated by investigator

    Measured: at week 4, 8, 12

  5. Global assessment evaluated by patients

    Measured: at week 4, 8, 12

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

    Measured: from baseline at week 4, 8, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionMay 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01915459
Sponsor's protocol ID
HG-13-01
Status last verified
Apr 2015
First submitted
1 Aug 2013
Last updated
4 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®) in people with Stroke and Spasticity, run by Hugel at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in MAS(Modified Ashworth Scale) grade (time frame: from baseline at week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01915459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.

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