Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy (ATHETOID_CD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Keewon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
First received: May 13, 2013
Last updated: December 5, 2013
Last verified: December 2013
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 Intervention Phase
Adult Cerebral Palsy
Drug: Meditoxin
Drug: Normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: 0, 16, 32 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pain in numerical rating scale (NRS)

  • Japanese Orthopaedic Association (JOA) score [ Time Frame: Every 4 weeks, up to 32 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    vital sign, adverse effect

  • computed tomography (CT) [ Time Frame: 0, 32 weeks ] [ Designated as safety issue: Yes ]
    Change of cervical spine computed tomography (CT) from baseline CT at 0 week.

  • videofluoroscopic swallowing study (VFSS) [ Time Frame: 0, 12, 28 weeks ] [ Designated as safety issue: Yes ]
    Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.

  • Blood/Urine laboratory tests [ Time Frame: 0, 16, 32 weeks ] [ Designated as safety issue: Yes ]
    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

Estimated Enrollment: 28
Study Start Date: June 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment-Placebo Group
Treatment on 0 day Placebo at 5th week
Drug: Meditoxin
Active Comparator: Placebo-Treatment Group
Placebo on 0 day Treatment at 5th week
Drug: Normal saline


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Keewon Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01860196     History of Changes
Other Study ID Numbers: MT_IT_009 
Study First Received: May 13, 2013
Last Updated: December 5, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 25, 2016