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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Keewon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01860196
First received: May 13, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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:
Torticollis
Cerebral Palsy
Dystonia
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Dystonic Disorders
Movement Disorders

ClinicalTrials.gov processed this record on July 26, 2014