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Completed

NCT Number: NCT01860196

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.

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Key information

Conditions

Adult Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditoxin

Drug

normal saline

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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

    • 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: ATHETOID_CD

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 22, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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