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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02175693
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : March 23, 2018
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 : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 2, 2013
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : August 31, 2019


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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02175693

Contact: Customer Information Services Department. CRC and QA

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

Responsible Party: Eisai Co., Ltd. Identifier: NCT02175693     History of Changes
Other Study ID Numbers: NB01S
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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

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