NCT02175719

Brief Summary

Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-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 16, 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
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

4.7 years

First QC Date

June 24, 2014

Last Update Submit

July 10, 2018

Conditions

Cervical Dystonia

Keywords

TorticollisrimabotulinumtoxinB

Outcome Measures

Primary Outcomes (1)

  • Whole improvement level

    Toronto Western Spasmodic Torticollis Scale (TWSTRS)

    Up to 1 year

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 who was treated by botulinum toxin type A in the past.

You may qualify if:

  • Patients with cervical dystonia who was treated by botulinum toxin type A in the past.
  • Patients who was enrolled in NB01S and was evaluated by TWSTRS at the first injection of NerBloc.

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 16, 2013

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

JP(2)