NCT02175693

Brief Summary

Investigation of the clinical condition and safety in patients with cervical dystonia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

April 2, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 9, 2020

Status Verified

March 1, 2018

Enrollment Period

6.2 years

First QC Date

June 24, 2014

Last Update Submit

January 7, 2020

Conditions

Cervical Dystonia

Keywords

TorticollisrimabotulinumtoxinB

Outcome Measures

Primary Outcomes (1)

  • Overall assessments of the improvement in the seriousness of seizures

    Improvement is based on the 5 following elements: 1) Eminent improvement 2) Improvement 3) Improvement a little invariability 5) Exacerbation 6) It is not possible to judge

    Up to 3 years

Study Arms (1)

E2014

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cervical dystonia

You may qualify if:

  • Patients with cervical dystonia

You may not qualify if:

  • The patients who participated in this surveillance in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Akira Endo

    Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 26, 2014

Study Start

April 2, 2013

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 9, 2020

Record last verified: 2018-03

Locations

JP(2)