ClinicalTrials.gg
CompletedNCT01728428Updated Nov 19, 2012

A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients

An observational study in Hemifacial Spasm, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-11-19.

Sponsored by Peking Union Medical College Hospital · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
1,003
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hemifacial Spasm

Browse trials for

Keywords

  • hemifacial spasm
  • observational study
  • clinical manifestation
  • treatment
  • Chinese
03

In context

Hemifacial Spasm

23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.

This study's enrollment of 1,003 is above the median of 105 across 11 observational studies indexed under Hemifacial Spasm.

Browse Hemifacial Spasm studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

About 1000 Outpatient subjects from 15 centers across China.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1.Clinically diagnosed primary hemifacial spasm

  1. Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.
  2. No other neurological disorder. 2.Male or female 18 to 80 years old 3. has been obtained

Exclusion criteria

Exclusion Criteria:

  1. Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.
  2. Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures.
  3. History of surgery of microvascular decompression of the facial nerve.
  4. Participation in another clinical study currently.
  5. Not able to understand and answer questionnaire.
  6. Investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Time perspective
Retrospective
Enrollment
1,003 participants (actual)
06

What researchers measure

Primary outcomes

  1. The percentage of the treatment methods of HFS in outpatient subjects

    Time frame: November, 2012

Secondary outcomes

  1. Distribution of onset age of hemifacial spasm patients

    Time frame: November, 2012

  2. Analysis of aggrevated and relieved factors of HFS symptom

    Time frame: November, 2012

  3. Analysis of concomitant symptoms of hemifacial spasm

    Time frame: November, 2012

  4. Adverse events of botulinum toxin treatment in hemifacial spasm

    Time frame: November, 2012

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100032, China
08

References and documents

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 15050451 ↗
  • Wang 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 9843077 ↗
  • Tan 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 12145388 ↗
  • Au 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 15175773 ↗
  • Kenney 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Sep 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2012
First posted
Nov 19, 2012
Start
Feb 2012
Primary completionActual
Sep 2012
CompletionActual
Nov 2012
Last update
Nov 19, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01728428
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 19, 2012
Start date
Feb 2012
Primary completion
Sep 2012
Completion
Nov 2012
Last update
Nov 19, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion