Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy (ATHETOID_CD)
Primary Purpose
Adult Cerebral Palsy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Meditoxin
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Adult Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Adult cerebral palsy patients over 20 years old
- Clinically diagnosed for cervical dystonia more than a year ago
- No improvement with antispasmodics for the last month
- Actively participated and gave informed consent
Exclusion Criteria:
- Allergic to the botulinum toxin
- Limited range of motion in cervical spine
- Patients with fever, infection, cancer, uncontrollable seizure
- Generalized neuromuscular junction disease patients
- Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
- Patients enrolled in other studies
- History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
- Botulinum toxin injection history in 6 months
- Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
- Otherwise clinically non-eligible patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment-Placebo Group
Placebo-Treatment Group
Arm Description
Treatment on 0 day Placebo at 5th week
Placebo on 0 day Treatment at 5th week
Outcomes
Primary Outcome Measures
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.
Secondary Outcome Measures
Pain in numerical rating scale (NRS)
Pain in numerical rating scale (NRS)
Japanese Orthopaedic Association (JOA) score
Change of Japanese Orthopaedic Association (JOA) score from baseline Japanese Orthopaedic Association (JOA) score at 0 week.
Goal attainment scale
Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks.
Full Information
NCT ID
NCT01860196
First Posted
May 13, 2013
Last Updated
August 19, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01860196
Brief Title
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
Acronym
ATHETOID_CD
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment-Placebo Group
Arm Type
Active Comparator
Arm Description
Treatment on 0 day Placebo at 5th week
Arm Title
Placebo-Treatment Group
Arm Type
Active Comparator
Arm Description
Placebo on 0 day Treatment at 5th week
Intervention Type
Drug
Intervention Name(s)
Meditoxin
Intervention Type
Drug
Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Description
Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.
Time Frame
0, 16, 32 weeks
Secondary Outcome Measure Information:
Title
Pain in numerical rating scale (NRS)
Description
Pain in numerical rating scale (NRS)
Time Frame
Every 4 weeks, up to 32 weeks
Title
Japanese Orthopaedic Association (JOA) score
Description
Change of Japanese Orthopaedic Association (JOA) score from baseline Japanese Orthopaedic Association (JOA) score at 0 week.
Time Frame
Every 4 weeks, up to 32 weeks
Title
Goal attainment scale
Description
Goal attainment scale of subjective improvement from the baseline status at 0 and 16 weeks.
Time Frame
4, 12, 20, 28 weeks
Other Pre-specified Outcome Measures:
Title
Adverse effect
Description
vital sign, adverse effect
Time Frame
Every 4 weeks, up to 32 weeks
Title
computed tomography (CT)
Description
Change of cervical spine computed tomography (CT) from baseline CT at 0 week.
Time Frame
0, 32 weeks
Title
videofluoroscopic swallowing study (VFSS)
Description
Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.
Time Frame
0, 12, 28 weeks
Title
Blood/Urine laboratory tests
Description
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
Time Frame
0, 16, 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult cerebral palsy patients over 20 years old
Clinically diagnosed for cervical dystonia more than a year ago
No improvement with antispasmodics for the last month
Actively participated and gave informed consent
Exclusion Criteria:
Allergic to the botulinum toxin
Limited range of motion in cervical spine
Patients with fever, infection, cancer, uncontrollable seizure
Generalized neuromuscular junction disease patients
Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
Patients enrolled in other studies
History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
Botulinum toxin injection history in 6 months
Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
Otherwise clinically non-eligible patients
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
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