Trial record 2 of 11 for:    Hemifacial Spasm

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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01728428
First received: November 13, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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


Condition
Hemifacial Spasm

Study Type: Observational
Study Design: Time Perspective: Retrospective

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • The percentage of the treatment methods of HFS in outpatient subjects [ Time Frame: November, 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of onset age of hemifacial spasm patients [ Time Frame: November, 2012 ] [ Designated as safety issue: No ]
  • Analysis of aggrevated and relieved factors of HFS symptom [ Time Frame: November, 2012 ] [ Designated as safety issue: No ]
  • Analysis of concomitant symptoms of hemifacial spasm [ Time Frame: November, 2012 ] [ Designated as safety issue: No ]
  • Adverse events of botulinum toxin treatment in hemifacial spasm [ Time Frame: November, 2012 ] [ Designated as safety issue: Yes ]

Enrollment: 1003
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

About 1000 Outpatient subjects from 15 centers across China.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728428

Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Peking Union Medical College Hospital
GlaxoSmithKline
  More Information

Publications:
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01728428     History of Changes
Other Study ID Numbers: 116414
Study First Received: November 13, 2012
Last Updated: November 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College Hospital:
hemifacial spasm
observational study
clinical manifestation
treatment
Chinese

Additional relevant MeSH terms:
Spasm
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 23, 2014