Dose-response Relationship of Botullinum Toxin (DWP 450)... | NCT03517319

NCT03517319

Status Module

Sponsor/Collaborators Module

Name	Class
Daewoong Pharmaceutical Co. LTD.	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Normal Saline 0.9% 1.2 ml will be injected to finger flexor muscles	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	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	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	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	Drug: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U

Name	Type	Description	Arm Group Labels	Other Names
Normal Saline 0.9% 1.2 ml	Drug		Placebo
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	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

Measure	Description	Time Frame
Ultrasonography	measurement of changes of cross sectional area	baseline
Ultrasonography	measurement of changes of cross sectional area

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Shi-Uk Lee, MD, PhD	Contact			shiuk.lee@gmail.com
Min Hyung Lee	Contact			0206330@gmail.com

Name	Affiliation	Role
Shi-Uk Lee	Seoul National University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government-Seoul National University Boramae Medical Center	Recruiting	Seoul	Dong Jak Ku	156-707	South Korea

References Module

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IPD Sharing Statement Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

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Intervention Browse Module

Masking Info

Shi-Uk Lee, MD, PhDContactshiuk.lee@gmail.com

ID	Term
D000077330	Saline Solution
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D045726	Metalloproteases
D001426	Bacterial Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001427	Bacterial Toxins
D014118	Toxins, Biological
D001685	Biological Factors