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

NCT ID: NCT01728428

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1003 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-11-30

Brief Summary

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To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects

Detailed Description

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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

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Hemifacial Spasm

Keywords

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hemifacial spasm observational study clinical manifestation treatment Chinese

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 15050451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9843077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12145388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15175773 (View on PubMed)

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.

Reference Type RESULT
PMID: 17558461 (View on PubMed)

Other Identifiers

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116414

Identifier Type: -

Identifier Source: org_study_id