Spasticity as Sequela of StrokePhase 4NCT03517319
Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
A Phase 4 study testing Normal Saline 0.9% 1.2 ml, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U and Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U in people with Spasticity as Sequela of Stroke, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- Normal Saline 0.9% 1.2 ml, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U and Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2016to Jun 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 6 weeks after stroke onset
- MAS (modified Ashworth scale) greater than 2 in finger flexor
Who cannot join
- neuromuscular junction disease or motor neuron disease
- phenol or alcohol block for the target limbs within 6 months before screening
- botulinum toxin injection within 3 months before screening
- history or plan for tendon lengthening surgery
- significant contracture ormuscle atrophy at the target joint or muscle
- concurrent treatment with intrathecal baclofen
Show all 9Show fewer
- hypersensitivity or allergy to study drug or its components
- pregnancy or planned pregnancy, breastfeeding
- abnormal lab findings for alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, and serum creatinine.
Trial locations and contacts
1 site in 1 country.
Shi-Uk Lee, MD, PhD contact
Min Hyung Lee contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, Dong Jak Ku, 156-707
Shi-Uk Lee, MD, PhD, shiuk.lee@gmail.com
About this study
Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U
Read the detailed description
Seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be recruited and randomly assigned to one of 5 groups. The groups are as followings.
Gp 1: placebo group (Normal saline 1.2 ml) Gp 2: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U Gp 3: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U Gp 4: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U Gp 5: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U
According to the group, the injection will be performed to the finger flexor musles (flexor digitorum superficialis and profundus). Outcome measurement will be MAS (Modified ashworth scale), FMA, Wolf Motor Assessment, Cross sectional area measured by Ultrasonography.
Patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the injection.
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- Normal Saline 0.9% 1.2 ml, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline 0.9% 1.2 mlDrug
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 UDrug
Also called Nabota (DWP 450)
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 UDrug
Also called Nabota (DWP 450)
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 UDrug
Also called Nabota (DWP 450)
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 UDrug
Also called Nabota (DWP 450)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal Saline 0.9% 1.2 ml will be injected to finger flexor muscles Receives: Drug: Normal Saline 0.9% 1.2 ml |
| Treatment dose 15 | Experimental | Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U will be injected to finger flexor muscles Receives: Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U |
| Treatment dose 30 | Experimental | Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U will be injected to finger flexor muscles Receives: Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U |
| Treatment dose 50 | Experimental | Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U will be injected to finger flexor muscles Receives: Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U |
| Treatment dose 70 | Experimental | Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U will be injected to finger flexor muscles Receives: Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: baseline
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: 2wks after injection
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: 4wks after injection
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: 8wks after injection
MAS (Modified Ashworth Scale)
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: 12wks after injection
Secondary outcomes (15)
Ultrasonography
measurement of changes of cross sectional area
Measured: baseline
Ultrasonography
measurement of changes of cross sectional area
Measured: 2wks after injection
Ultrasonography
measurement of changes of cross sectional area
Measured: 4wks after injection
Ultrasonography
measurement of changes of cross sectional area
Measured: 8wks after injection
Ultrasonography
measurement of changes of cross sectional area
Measured: 12wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Measured: baseline
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Measured: 2 wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Measured: 4 wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Measured: 8 wks after injection
Fugl Myer Upper Extremity Assessment
measurement of upper extremity function
Measured: 12 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Measured: baseline
Wolf Motor Assessment
measurement of upper extremity function
Measured: 2 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Measured: 4 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Measured: 8 wks after injection
Wolf Motor Assessment
measurement of upper extremity function
Measured: 12 wks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Sep 2016
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity as Sequela of StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Shi-Uk Lee, Seoul National University Hospital
- Investigators
- Shi-Uk Lee, Study chair, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517319
- Sponsor's protocol ID
- 26-2016-103
- Status last verified
- May 2018
- First submitted
- 17 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
- ClinicalTrials.gov ID
- NCT03517319
- Acronym / sponsor ID
- 26-2016-103
- Conditions
- Spasticity as Sequela of Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U
Detailed description
Seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be recruited and randomly assigned to one of 5 groups. The groups are as followings.
Gp 1: placebo group (Normal saline 1.2 ml) Gp 2: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U Gp 3: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U Gp 4: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U Gp 5: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U
According to the group, the injection will be performed to the finger flexor musles (flexor digitorum superficialis and profundus). Outcome measurement will be MAS (Modified ashworth scale), FMA, Wolf Motor Assessment, Cross sectional area measured by Ultrasonography.
Patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Normal Saline 0.9% 1.2 mlNormal Saline 0.9% 1.2 ml will be injected to finger flexor muscles |
| Treatment dose 15 | Experimental | Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 UClostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U will be injected to finger flexor muscles |
| Treatment dose 30 | Experimental | Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 UClostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U will be injected to finger flexor muscles |
| Treatment dose 50 | Experimental | Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 UClostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U will be injected to finger flexor muscles |
| Treatment dose 70 | Experimental | Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 UClostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U will be injected to finger flexor muscles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 6 weeks after stroke onset
- MAS (modified Ashworth scale) greater than 2 in finger flexor
Key exclusion criteria (9 listed)
- neuromuscular junction disease or motor neuron disease
- phenol or alcohol block for the target limbs within 6 months before screening
- botulinum toxin injection within 3 months before screening
- history or plan for tendon lengthening surgery
- significant contracture ormuscle atrophy at the target joint or muscle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline 0.9% 1.2 ml | Drug | Placebo |
| Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 UAlso: Nabota (DWP 450) | Drug | Treatment dose 15 |
| Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 UAlso: Nabota (DWP 450) | Drug | Treatment dose 30 |
| Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 UAlso: Nabota (DWP 450) | Drug | Treatment dose 50 |
| Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 UAlso: Nabota (DWP 450) | Drug | Treatment dose 70 |
Primary outcome
MAS (Modified Ashworth Scale)
Time frame: baseline
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
MAS (Modified Ashworth Scale)
Time frame: 2wks after injection
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
MAS (Modified Ashworth Scale)
Time frame: 4wks after injection
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
MAS (Modified Ashworth Scale)
Time frame: 8wks after injection
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
MAS (Modified Ashworth Scale)
Time frame: 12wks after injection
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
15 secondary outcomes
Ultrasonography
Time frame: baseline
Ultrasonography
Time frame: 2wks after injection
Ultrasonography
Time frame: 4wks after injection
Ultrasonography
Time frame: 8wks after injection
Ultrasonography
Time frame: 12wks after injection
Fugl Myer Upper Extremity Assessment
Time frame: baseline
Fugl Myer Upper Extremity Assessment
Time frame: 2 wks after injection
Fugl Myer Upper Extremity Assessment
Time frame: 4 wks after injection
Fugl Myer Upper Extremity Assessment
Time frame: 8 wks after injection
Fugl Myer Upper Extremity Assessment
Time frame: 12 wks after injection
Wolf Motor Assessment
Time frame: baseline
Wolf Motor Assessment
Time frame: 2 wks after injection
Wolf Motor Assessment
Time frame: 4 wks after injection
Wolf Motor Assessment
Time frame: 8 wks after injection
Wolf Motor Assessment
Time frame: 12 wks after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi-Uk Lee, MD, PhD contact
Min Hyung Lee contact
Shi-Uk Lee study chair
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline 0.9% 1.2 ml, Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U and Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U in people with Spasticity as Sequela of Stroke, run by Seoul National University Hospital at 1 site 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi-Uk Lee, MD, PhD (shiuk.lee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAS (Modified Ashworth Scale) (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2018.