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Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition and Safety in Patients With Cervical Dystonia

Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02175693
Collaborator
(none)
1,647
Enrollment
2
Locations
74.9
Actual Duration (Months)
823.5
Patients Per Site
11
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1647 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Apr 2, 2013
    Actual Primary Completion Date :
    Jun 30, 2019
    Actual Study Completion Date :
    Jun 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    E2014

    Outcome Measures

    Primary Outcome Measures

    1. Overall assessments of the improvement in the seriousness of seizures [Up to 3 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    Patients with cervical dystonia

    Exclusion criteria:

    The patients who participated in this surveillance in the past

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka Japan
    2 Tokyo Japan

    Sponsors and Collaborators

    • Eisai Co., Ltd.

    Investigators

    • Study Director: Akira Endo, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02175693
    Other Study ID Numbers:
    • NB01S
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    Jan 9, 2020
    Last Verified:
    Mar 1, 2018
    Keywords provided by Eisai Co., Ltd.
    Torticollis
    rimabotulinumtoxinB
    Additional relevant MeSH terms:
    Dystonia
    Dystonic Disorders
    Torticollis

    Study Results

    No Results Posted as of Jan 9, 2020