Cervical DystoniaNCT02175719
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
An observational study of Cervical Dystonia, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Dystonia
- How many people
- 150 participants
- Where
- 2 sitesJapan
- Study dates
- 16 Apr 2013to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cervical dystonia who was treated by botulinum toxin type A in the past.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)
- Conditions
- Cervical Dystonia
- Keywords
- Torticollis, rimabotulinumtoxinB
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| E2014 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole improvement level
Toronto Western Spasmodic Torticollis Scale (TWSTRS)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study start16 Apr 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akira Endo, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175719
- Sponsor's protocol ID
- NB02T
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2014
- Last updated
- 11 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02175719
- Acronym / sponsor ID
- NB02T
- Conditions
- Cervical Dystonia
- Keywords
- Torticollis, rimabotulinumtoxinB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E2014 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cervical dystonia who was treated by botulinum toxin type A in the past.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole improvement level
Time frame: Up to 1 year
Toronto Western Spasmodic Torticollis Scale (TWSTRS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akira Endo study director
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia, run by Eisai Co., Ltd. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole improvement level (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.