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Intracranial Pressure in Experimental Models of Headache

This study has been completed.
Sponsor:
Collaborators:
Research Center for Sport, Mountain and Health of Rovereto, University of Verona, Italy
North Wales Research Committee, UK
Information provided by (Responsible Party):
Bangor University
ClinicalTrials.gov Identifier:
NCT01288781
First received: January 27, 2011
Last updated: February 6, 2012
Last verified: December 2011
History of Changes
Results First Received: November 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: High Altitude Headache
Interventions: Drug: Acetazolamide
Drug: Lactose monohydrate

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Acetazolamide Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Placebo Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Total Total of all reporting groups

Baseline Measures
    Acetazolamide     Placebo     Total  
Number of Participants  
[units: participants]
 		  11     12     23  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     12     23  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  24  ± 6     20  ± 1     21  ± 3  
Gender  
[units: participants]
 		     
Female     2     4     6  
Male     9     8     17  
Region of Enrollment  
[units: participants]
 		     
United Kingdom     11     12     23  



  Outcome Measures
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1.  Primary:   Change in Optic Nerve Sheath Diameter by Ultrasonography   [ Time Frame: Optic Nerve Sheath Diameter: baseline, 24 hours. ]
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2.  Secondary:   Change in High Altitude Headache by Visual Analogue Scale   [ Time Frame: High Altitude Headache: baseline, 24 hours. ]
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3.  Secondary:   Change in Blood Oxygen Saturation   [ Time Frame: Blood Oxygen Saturation: baseline, 24 hours. ]
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4.  Secondary:   Change in Fluid Balance   [ Time Frame: Fluid Balance: baseline, 24 hours. ]
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5.  Secondary:   Change in Optic Nerve Sheath Diameter   [ Time Frame: Optic Nerve Sheath Diameter: baseline, 3 hours. ]
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6.  Secondary:   Change in Optic Nerve Sheath Diameter   [ Time Frame: Optic Nerve Sheath Diameter: baseline, 12 hours. ]
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7.  Secondary:   Change in Optic Nerve Sheath Diameter   [ Time Frame: Optic Nerve Sheath Diameter: baseline, 36 hours. ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Acetazolamide did not reduce high altitude headache as expected. Nevertheless the relationship between optic nerve sheath diameter and headache could still be determined by completing other analyses.  


Results Point of Contact:  
Name/Title: Mr Justin Stevan Lawley
Organization: UWalesBangor
phone: 00441248382810
e-mail: pepa16@bangor.ac.uk


No publications provided by Bangor University

Publications automatically indexed to this study:


Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01288781     History of Changes
Other Study ID Numbers: F002686, 2010-019520-31
Study First Received: January 27, 2011
Results First Received: November 24, 2011
Last Updated: February 6, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency