Primary DystoniaMDSNCT01168388
Movement Disorder Survey in East China
An observational study of Primary Dystonia and Hemifacial Spasm, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Movement disorder involve recurring or constant muscle contractions causing squeezing or twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most common focal dystonia was cervical dystonia in western countries according to previous studies, which is different from China in Chinese… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Dystonia, Hemifacial Spasm
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Aug 2010
- 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 seeking treatment in movement disorder clinics in east China during April 2010 to August 2010.
Who may be able to join
- Patients seeking treatment in movement disorder clinics(include naive or may have previously been to clinics)
Who cannot join
- Patients who have received this movement disorder survey
Trial locations and contacts
1 site in 1 country.
About this study
Movement disorder involve recurring or constant muscle contractions causing squeezing or twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most common focal dystonia was cervical dystonia in western countries according to previous studies, which is different from China in Chinese neurologists' opinion. And there is no such survey. So the investigators are conducting a movement disorder survey in east China to confirm it.
- Conditions
- Primary Dystonia, Hemifacial Spasm
- Keywords
- Dystonia, Hemifacial spasm, Cervical dystonia, Blepharospasm
- Medical subject headings
- Dystonic Disorders, Hemifacial Spasm, Dystonia, Torticollis, Blepharospasm
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 |
|---|---|---|
| Movement disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with primary dystonia
It is Cross-Sectional, service-based survey to study the primary dystonina prevalence in east China.
Measured: half year
Secondary outcomes (2)
Number of participants with hemifacial spasm
It is a Cross-Sectional survey to study the prevalence of hemifacial spasm in movement disorder of east China.
Measured: half year
Number of participants with blepharospasm
It is a Cross-Sectional survey to study the prevalence of blepharospasm in movement disorder of east China.
Measured: half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary DystoniaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Xingyue Hu, MD, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168388
- Sponsor's protocol ID
- SirRRSH-001
- Acronym
- MDS
- Status last verified
- Apr 2010
- First submitted
- 21 Jul 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castelon Konkiewitz E, Trender-Gerhard I, Kamm C, Warner T, Ben-Shlomo Y, Gasser T, Conrad B, Ceballos-Baumann AO. Service-based survey of dystonia in munich. Neuroepidemiology. 2002 Jul-Aug;21(4):202-6. doi: 10.1159/000059525.
PubMed 12065883Matsumoto S, Nishimura M, Shibasaki H, Kaji R. Epidemiology of primary dystonias in Japan: comparison with Western countries. Mov Disord. 2003 Oct;18(10):1196-8. doi: 10.1002/mds.10480.
PubMed 14534928Butler AG, Duffey PO, Hawthorne MR, Barnes MP. An epidemiologic survey of dystonia within the entire population of northeast England over the past nine years. Adv Neurol. 2004;94:95-9. No abstract available.
PubMed 14509660Muller J, Kiechl S, Wenning GK, Seppi K, Willeit J, Gasperi A, Wissel J, Gasser T, Poewe W. The prevalence of primary dystonia in the general community. Neurology. 2002 Sep 24;59(6):941-3. doi: 10.1212/01.wnl.0000026474.12594.0d.
PubMed 12297587Nutt JG, Muenter MD, Aronson A, Kurland LT, Melton LJ 3rd. Epidemiology of focal and generalized dystonia in Rochester, Minnesota. Mov Disord. 1988;3(3):188-94. doi: 10.1002/mds.870030302.
PubMed 3264051
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Disorder Survey in East China
- ClinicalTrials.gov ID
- NCT01168388
- Acronym / sponsor ID
- MDS / SirRRSH-001
- Conditions
- Primary Dystonia, Hemifacial Spasm
- Keywords
- Dystonia, Hemifacial spasm, Cervical dystonia, Blepharospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Jul 2010 (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.
Movement disorder involve recurring or constant muscle contractions causing squeezing or twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most common focal dystonia was cervical dystonia in western countries according to previous studies, which is different from China in Chinese neurologists' opinion. And there is no such survey. So the investigators are conducting a movement disorder survey in east China to confirm it.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Movement disorder | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seeking treatment in movement disorder clinics in east China during April 2010 to August 2010.
Key inclusion criteria (1 listed)
- Patients seeking treatment in movement disorder clinics(include naive or may have previously been to clinics)
Key exclusion criteria (1 listed)
- Patients who have received this movement disorder survey
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
Number of participants with primary dystonia
Time frame: half year
It is Cross-Sectional, service-based survey to study the primary dystonina prevalence in east China.
2 secondary outcomes
Number of participants with hemifacial spasm
Time frame: half year
Number of participants with blepharospasm
Time frame: half year
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 21 Jul 2011.
- Background: PubMed 12065883Castelon Konkiewitz E, Trender-Gerhard I, Kamm C, Warner T, Ben-Shlomo Y, Gasser T, Conrad B, Ceballos-Baumann AO. Service-based survey of dystonia in munich. Neuroepidemiology. 2002 Jul-Aug;21(4):202-6. doi: 10.1159/000059525.
- Background: PubMed 14534928Matsumoto S, Nishimura M, Shibasaki H, Kaji R. Epidemiology of primary dystonias in Japan: comparison with Western countries. Mov Disord. 2003 Oct;18(10):1196-8. doi: 10.1002/mds.10480.
- Background: PubMed 14509660Butler AG, Duffey PO, Hawthorne MR, Barnes MP. An epidemiologic survey of dystonia within the entire population of northeast England over the past nine years. Adv Neurol. 2004;94:95-9. No abstract available.
- Background: PubMed 12297587Muller J, Kiechl S, Wenning GK, Seppi K, Willeit J, Gasperi A, Wissel J, Gasser T, Poewe W. The prevalence of primary dystonia in the general community. Neurology. 2002 Sep 24;59(6):941-3. doi: 10.1212/01.wnl.0000026474.12594.0d.
- Background: PubMed 3264051Nutt JG, Muenter MD, Aronson A, Kurland LT, Melton LJ 3rd. Epidemiology of focal and generalized dystonia in Rochester, Minnesota. Mov Disord. 1988;3(3):188-94. doi: 10.1002/mds.870030302.
Related trials for Primary Dystonia
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Not yet recruitingPhase 1/2
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)
RecruitingObservational study
Dystonia Genotype-Phenotype Correlation
Dystonia, Dystonia; Idiopathic
Active, not recruitingObservational study
An Observational Study of Individuals With Isolated Dystonia
Isolated/Primary Dystonia That Affects More Than One Region of the Body
RecruitingObservational study
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Movement Disorders, Parkinson Disease
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.
Xingyue Hu, MD study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dystonia and Hemifacial Spasm, run by Sir Run Run Shaw Hospital at 1 site in China.
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 1 inclusion and 1 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 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Number of participants with primary dystonia (time frame: half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01168388, which also lists 5 linked publications.
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 21 Jul 2011.