- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860196
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy (ATHETOID_CD)
August 19, 2017 updated by: Keewon Kim, Seoul National University Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0, 16, 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain in numerical rating scale (NRS)
Time Frame: Every 4 weeks, up to 32 weeks
|
Pain in numerical rating scale (NRS)
|
Every 4 weeks, up to 32 weeks
|
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.
|
Every 4 weeks, up to 32 weeks
|
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.
|
4, 12, 20, 28 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse effect
Time Frame: Every 4 weeks, up to 32 weeks
|
vital sign, adverse effect
|
Every 4 weeks, up to 32 weeks
|
computed tomography (CT)
Time Frame: 0, 32 weeks
|
Change of cervical spine computed tomography (CT) from baseline CT at 0 week.
|
0, 32 weeks
|
videofluoroscopic swallowing study (VFSS)
Time Frame: 0, 12, 28 weeks
|
Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.
|
0, 12, 28 weeks
|
Blood/Urine laboratory tests
Time Frame: 0, 16, 32 weeks
|
|
0, 16, 32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
May 13, 2013
First Submitted That Met QC Criteria
May 19, 2013
First Posted (Estimate)
May 22, 2013
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 19, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Brain Damage, Chronic
- Dyskinesias
- Cerebral Palsy
- Dystonia
- Torticollis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins, Type A
Other Study ID Numbers
- MT_IT_009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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