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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

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.

Condition or disease Intervention/treatment Phase
Adult Cerebral Palsy Drug: Meditoxin Drug: Normal saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain in numerical rating scale (NRS) [ Time Frame: Every 4 weeks, up to 32 weeks ]
    Pain in numerical rating scale (NRS)

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Adverse effect [ Time Frame: Every 4 weeks, up to 32 weeks ]
    vital sign, adverse effect

  2. computed tomography (CT) [ Time Frame: 0, 32 weeks ]
    Change of cervical spine computed tomography (CT) from baseline CT at 0 week.

  3. videofluoroscopic swallowing study (VFSS) [ Time Frame: 0, 12, 28 weeks ]
    Change of videofluoroscopic swallowing study (VFSS) from baseline VFSS at 0 week.

  4. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Keewon Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01860196     History of Changes
Other Study ID Numbers: MT_IT_009
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Dystonia
Torticollis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Dystonic Disorders
Movement Disorders
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents