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

Hemifacial Spasm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728428
• Other study ID #: 116414
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: November 13, 2012
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hemifacial Spasm
• Spasm

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	GlaxoSmithKline

Country where clinical trial is conducted

China, 

References & Publications (5)

Au WL, Tan LC, Tan AK. Hemifacial spasm in Singapore: clinical characteristics and patients ' perceptions. Ann Acad Med Singapore. 2004 May;33(3):324-8. — View Citation

Kenney C, Jankovic J. Botulinum toxin in the treatment of blepharospasm and hemifacial spasm. J Neural Transm (Vienna). 2008;115(4):585-91. Epub 2007 Jun 11. Review. — View 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. — View Citation

Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. Review. — View Citation

Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve. 1998 Dec;21(12):1740-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of the treatment methods of HFS in outpatient subjects		November, 2012	No
Secondary	Distribution of onset age of hemifacial spasm patients		November, 2012	No
Secondary	Analysis of aggrevated and relieved factors of HFS symptom		November, 2012	No
Secondary	Analysis of concomitant symptoms of hemifacial spasm		November, 2012	No
Secondary	Adverse events of botulinum toxin treatment in hemifacial spasm		November, 2012	Yes