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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
Sponsor:
Information provided by (Responsible Party):
Keewon Kim, Seoul National University Hospital

May 13, 2013
May 22, 2013
August 22, 2017
June 2013
March 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01860196 on ClinicalTrials.gov Archive Site
  • 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.
Adverse effect [ Time Frame: Every 4 weeks, up to 32 weeks ]
vital sign, adverse effect
  • 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 ]
    1. Hemoglobin, Hematocrit, RBC, WBC, WBC different cell count, Platelet
    2. Alkaline phosphatase, BUN, Creatinine, SGPT(ALT), SGOT(AST), Albumin, Total protein, Total bilirubin, Uric acid, Glucose, Cholesterol, LDH, Na, Ca, K, Cl
    3. Urine pH, Protein, Glucose, Bilirubin, Blood, WBC
Laboratory / Imaging tests [ Time Frame: 0, 16, 32 weeks ]
Change of cervical spine computed tomography (CT), videofluoroscopic swallowing study (VFSS), and blood tests from baseline TWSTRS at 0 week.
 
Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Adult Cerebral Palsy
  • Drug: Meditoxin
  • Drug: Normal saline
  • Active Comparator: Treatment-Placebo Group
    Treatment on 0 day Placebo at 5th week
    Intervention: Drug: Meditoxin
  • Active Comparator: Placebo-Treatment Group
    Placebo on 0 day Treatment at 5th week
    Intervention: Drug: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
June 2017
March 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01860196
MT_IT_009
Not Provided
Not Provided
Not Provided
Keewon Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP