Hemifacial SpasmNCT01728428
A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients
An observational study of Hemifacial Spasm, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemifacial Spasm
- How many people
- 1,003 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Nov 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: About 1000 Outpatient subjects from 15 centers across China.
Who may be able to join
- 1.Clinically diagnosed primary hemifacial spasm
- Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.
- No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent has been obtained
Who cannot join
- Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.
- Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures.
- History of surgery of microvascular decompression of the facial nerve.
- Participation in another clinical study currently.
- Not able to understand and answer questionnaire.
- Investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
About this study
To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects
Read the detailed description
About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. The exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. The outcome measures include the percentage of the treatment methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom, concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.
- Conditions
- Hemifacial Spasm
- Keywords
- hemifacial spasm, observational study, clinical manifestation, treatment, Chinese
- Medical subject headings
- Hemifacial Spasm
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of the treatment methods of HFS in outpatient subjects
Measured: November, 2012
Secondary outcomes (4)
Distribution of onset age of hemifacial spasm patients
Measured: November, 2012
Analysis of aggrevated and relieved factors of HFS symptom
Measured: November, 2012
Analysis of concomitant symptoms of hemifacial spasm
Measured: November, 2012
Adverse events of botulinum toxin treatment in hemifacial spasm
Measured: November, 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionNov 2012
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 Hemifacial SpasmStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Retrospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728428
- Sponsor's protocol ID
- 116414
- Status last verified
- Nov 2012
- First submitted
- 13 Nov 2012
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan EK, Fook-Chong S, Lum SY, Lim E. Botulinum toxin improves quality of life in hemifacial spasm: validation of a questionnaire (HFS-30). J Neurol Sci. 2004 Apr 15;219(1-2):151-5. doi: 10.1016/j.jns.2004.01.010.
PubMed 15050451Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve. 1998 Dec;21(12):1740-7. doi: 10.1002/(sici)1097-4598(199812)21:123.0.co;2-v.
PubMed 9843077Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. doi: 10.1093/qjmed/95.8.493.
PubMed 12145388Au WL, Tan LC, Tan AK. Hemifacial spasm in Singapore: clinical characteristics and patients ' perceptions. Ann Acad Med Singap. 2004 May;33(3):324-8.
PubMed 15175773Kenney C, Jankovic J. Botulinum toxin in the treatment of blepharospasm and hemifacial spasm. J Neural Transm (Vienna). 2008;115(4):585-91. doi: 10.1007/s00702-007-0768-7. Epub 2007 Jun 11.
PubMed 17558461
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients
- ClinicalTrials.gov ID
- NCT01728428
- Acronym / sponsor ID
- 116414
- Conditions
- Hemifacial Spasm
- Keywords
- hemifacial spasm, observational study, clinical manifestation, treatment, Chinese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Nov 2012 (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.
To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects
Detailed description
About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. The exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. The outcome measures include the percentage of the treatment methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom, concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 1000 Outpatient subjects from 15 centers across China.
Key inclusion criteria (3 listed)
- 1.Clinically diagnosed primary hemifacial spasm
- Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.
- No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent has been obtained
Key exclusion criteria (6 listed)
- Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.
- Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures.
- History of surgery of microvascular decompression of the facial nerve.
- Participation in another clinical study currently.
- Not able to understand and answer questionnaire.
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
The percentage of the treatment methods of HFS in outpatient subjects
Time frame: November, 2012
4 secondary outcomes
Distribution of onset age of hemifacial spasm patients
Time frame: November, 2012
Analysis of aggrevated and relieved factors of HFS symptom
Time frame: November, 2012
Analysis of concomitant symptoms of hemifacial spasm
Time frame: November, 2012
Adverse events of botulinum toxin treatment in hemifacial spasm
Time frame: November, 2012
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 19 Nov 2012.
- Background: PubMed 15050451Tan EK, Fook-Chong S, Lum SY, Lim E. Botulinum toxin improves quality of life in hemifacial spasm: validation of a questionnaire (HFS-30). J Neurol Sci. 2004 Apr 15;219(1-2):151-5. doi: 10.1016/j.jns.2004.01.010.
- Background: PubMed 9843077Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve. 1998 Dec;21(12):1740-7. doi: 10.1002/(sici)1097-4598(199812)21:123.0.co;2-v.
- Background: PubMed 12145388Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. doi: 10.1093/qjmed/95.8.493.
- Background: PubMed 15175773Au WL, Tan LC, Tan AK. Hemifacial spasm in Singapore: clinical characteristics and patients ' perceptions. Ann Acad Med Singap. 2004 May;33(3):324-8.
- Results publication: PubMed 17558461Kenney C, Jankovic J. Botulinum toxin in the treatment of blepharospasm and hemifacial spasm. J Neural Transm (Vienna). 2008;115(4):585-91. doi: 10.1007/s00702-007-0768-7. Epub 2007 Jun 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemifacial Spasm, run by Peking Union Medical College 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 3 inclusion and 6 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 19 Nov 2012. 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?
The percentage of the treatment methods of HFS in outpatient subjects (time frame: November, 2012). 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 NCT01728428, 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 19 Nov 2012.