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Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A

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ClinicalTrials.gov Identifier: NCT02175719
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease
Cervical Dystonia

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 16, 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017


Group/Cohort
E2014



Primary Outcome Measures :
  1. Whole improvement level [ Time Frame: Up to 1 year ]
    Toronto Western Spasmodic Torticollis Scale (TWSTRS)



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

Inclusion criteria:

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.


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): NCT02175719


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: NCT02175719     History of Changes
Other Study ID Numbers: NB02T
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Dystonia
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents