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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

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ClinicalTrials.gov Identifier: NCT02175693
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease
Cervical Dystonia

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


Group/Cohort
E2014



Primary Outcome Measures :
  1. Overall assessments of the improvement in the seriousness of seizures [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cervical dystonia
Criteria

Inclusion criteria:

Patients with cervical dystonia

Exclusion criteria:

The patients who participated in this surveillance in the past


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175693


Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Akira Endo Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02175693     History of Changes
Other Study ID Numbers: NB01S
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: March 2018

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Torticollis
rimabotulinumtoxinB

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases