NCT03232320

Brief Summary

To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 6, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

July 25, 2017

Last Update Submit

March 25, 2019

Conditions

DystoniaDystonic Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline

    week 4 follow-up visit

Secondary Outcomes (3)

  • Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline

    week 4 follow-up visit

  • Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline

    week 4 follow-up visit

  • Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline

    week 4 follow-up visit

Study Arms (2)

MEDITOXIN

EXPERIMENTAL
Drug: Meditoxin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MeditoxinDRUG

Meditoxin (Botulinum toxin type A)

MEDITOXIN
PlaceboDRUG

Placebo (Normal saline)

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 20 to less than 75 years
  • Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score \>=20 and TWSTRS-Severity score \>=10

You may not qualify if:

  • Subjects with pure anterocollis
  • Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
  • A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
  • Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

DystoniaDystonic Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMovement DisordersCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

July 6, 2017

Primary Completion

October 31, 2018

Study Completion

November 5, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

KR(1)