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The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01080287
First received: March 2, 2010
Last updated: February 20, 2012
Last verified: February 2012

March 2, 2010
February 20, 2012
September 2009
September 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01080287 on ClinicalTrials.gov Archive Site
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The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras

This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.

* The 3 assessments are

  1. passive upright tilt table testing,
  2. quantitative sudomotor axon reflex testing (QSART)and
  3. punch biopsy.

The comparison of results will be from two subject groups:

  • Group A, the migraine suffering patient with or without aura
  • Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult Migraineurs with and without auras, half having orthostatic intolerance.

Migraine
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  • Migraineurs with & w/out auras having orthostatic intolerance
    Subjects between ages 18 and 65, having ICHD-II classification of migraine with or without aura, having symptoms of orthostatic intolerance
  • Migraineurs with or without auras
    Subjects between ages 18 and 65 having ICHD-II classification of migraine with or without auras

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18 to 65
  • male or female
  • migraine diagnosis
  • may or may not have orthostatic intolerance
  • able to demonstrate study understanding and complete informed consent process

Exclusion Criteria:

  • subjects who do not meet inclusion criteria
  • subjects unable to complete informed consent process
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01080287
08-778
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Not Provided
The Cleveland Clinic
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP