NCT01860196

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

May 13, 2013

Last Update Submit

August 19, 2017

Conditions

Adult Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

    Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.

    0, 16, 32 weeks

Secondary Outcomes (3)

  • Pain in numerical rating scale (NRS)

    Every 4 weeks, up to 32 weeks

  • Japanese Orthopaedic Association (JOA) score

    Every 4 weeks, up to 32 weeks

  • Goal attainment scale

    4, 12, 20, 28 weeks

Other Outcomes (4)

  • Adverse effect

    Every 4 weeks, up to 32 weeks

  • computed tomography (CT)

    0, 32 weeks

  • videofluoroscopic swallowing study (VFSS)

    0, 12, 28 weeks

  • +1 more other outcomes

Study Arms (2)

Treatment-Placebo Group

ACTIVE COMPARATOR

Treatment on 0 day Placebo at 5th week

Drug: Meditoxin

Placebo-Treatment Group

ACTIVE COMPARATOR

Placebo on 0 day Treatment at 5th week

Drug: Normal saline

Interventions

MeditoxinDRUG
Treatment-Placebo Group
Normal salineDRUG
Placebo-Treatment Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type ASaline Solution

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 22, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08