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Completed

NCT Number: NCT01728428

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

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

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.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

Exclusion criteria

  • 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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2012
Registry last updated
Nov 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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