Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy (ATHETOID_CD)
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|ClinicalTrials.gov Identifier: NCT01860196|
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : August 22, 2017
Seoul National University Hospital
Information provided by (Responsible Party):
Keewon Kim, Seoul National University Hospital
This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.
|Condition or disease||Intervention/treatment||Phase|
|Adult Cerebral Palsy||Drug: Meditoxin Drug: Normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo Controlled, Cross-over, Double Blind, Randomized, Clinical Trial to Compare the Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||June 2017|
Resource links provided by the National Library of Medicine
U.S. FDA Resources
Active Comparator: Treatment-Placebo Group
Treatment on 0 day Placebo at 5th week
Active Comparator: Placebo-Treatment Group
Placebo on 0 day Treatment at 5th week
|Drug: Normal saline|
Primary Outcome Measures :
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: 0, 16, 32 weeks ]Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.
Secondary Outcome Measures :
- Pain in numerical rating scale (NRS) [ Time Frame: Every 4 weeks, up to 32 weeks ]Pain in numerical rating scale (NRS)
- Japanese Orthopaedic Association (JOA) score [ Time Frame: Every 4 weeks, up to 32 weeks ]Change of Japanese Orthopaedic Association (JOA) score from baseline Japanese Orthopaedic Association (JOA) score at 0 week.
- Goal attainment scale [ Time Frame: 4, 12, 20, 28 weeks ]Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks.
Other Outcome Measures:
- Adverse effect [ Time Frame: Every 4 weeks, up to 32 weeks ]vital sign, adverse effect
- computed tomography (CT) [ Time Frame: 0, 32 weeks ]Change of cervical spine computed tomography (CT) from baseline CT at 0 week.
- videofluoroscopic swallowing study (VFSS) [ Time Frame: 0, 12, 28 weeks ]Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.
- Blood/Urine laboratory tests [ Time Frame: 0, 16, 32 weeks ]
- Hemoglobin, Hematocrit, RBC, WBC, WBC different cell count, Platelet
- Alkaline phosphatase, BUN, Creatinine, SGPT(ALT), SGOT(AST), Albumin, Total protein, Total bilirubin, Uric acid, Glucose, Cholesterol, LDH, Na, Ca, K, Cl
- Urine pH, Protein, Glucose, Bilirubin, Blood, WBC
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