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

NCT01728428 | Completed DMC

• 1 other identifier: 116414
• Study Type: observational
• Target: 1,003
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemifacial Spasm

Keywords

hemifacial spasm; observational study; clinical manifestation; treatment; Chinese

Outcome Measures

Primary Outcomes (1)

• The percentage of the treatment methods of HFS in outpatient subjects

  November, 2012

Secondary Outcomes (4)

• Distribution of onset age of hemifacial spasm patients

  November, 2012

• Analysis of aggrevated and relieved factors of HFS symptom

  November, 2012

• Analysis of concomitant symptoms of hemifacial spasm

  November, 2012

• Adverse events of botulinum toxin treatment in hemifacial spasm

  November, 2012

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

About 1000 Outpatient subjects from 15 centers across China.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (5)

• 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.

  PMID: 15050451 BACKGROUND

• 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.

  PMID: 9843077 BACKGROUND

• 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.

  PMID: 12145388 BACKGROUND

• 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.

  PMID: 15175773 BACKGROUND

• 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.

  PMID: 17558461 RESULT

MeSH Terms

Conditions

Hemifacial Spasm

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 19, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

CN (1)