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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Cerebral Palsy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 13, 2013
    Last Updated
    August 19, 2017
    Sponsor
    Seoul National University Hospital
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    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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