Clinical trial NCT01728428: A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemifacial Spasm
Keywords: hemifacial spasm
observational study
clinical manifestation
treatment
Chinese
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-11-19
Enrollment: 1003
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 1000 Outpatient subjects from 15 centers across China.

Brief summary: 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.

Eligibility criteria: 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.Informed consent has been obtained

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.

Primary outcomes:
measure: The percentage of the treatment methods of HFS in outpatient subjects
timeFrame: November, 2012
Secondary outcomes:
measure: Distribution of onset age of hemifacial spasm patients
timeFrame: November, 2012
measure: Analysis of aggrevated and relieved factors of HFS symptom
timeFrame: November, 2012
measure: Analysis of concomitant symptoms of hemifacial spasm
timeFrame: November, 2012
measure: Adverse events of botulinum toxin treatment in hemifacial spasm
timeFrame: November, 2012
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.