Trial Outcomes & Findings for Intracranial Pressure in Experimental Models of Headache (NCT NCT01288781)

NCT ID: NCT01288781

Last Updated: 2012-02-07

Results Overview

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Optic Nerve Sheath Diameter: baseline, 24 hours.

Results posted on

2012-02-07

Participant Flow

Participants attending the Antur Ymchwil 2011 Expedition to the European Alps were recruited between 01.07.11 and 01.08.11.

Participants completed two trials, including a 12 hour sea level exposure followed by a 36 hour high altitude exposure (3777m). Participants were assigned to one of two groups based on High-altitude headache susceptibility determined by visual analogue score obtained after 12 hours at high altitude. No participants were excluded.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intracranial Pressure in Experimental Models of Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	24 years STANDARD_DEVIATION 6 • n=5 Participants	20 years STANDARD_DEVIATION 1 • n=7 Participants	21 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Optic Nerve Sheath Diameter: baseline, 24 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in Optic Nerve Sheath Diameter by Ultrasonography	0.02 mm Standard Deviation 0.06	0.02 mm Standard Deviation 0.06

SECONDARY outcome

Timeframe: High Altitude Headache: baseline, 24 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in High Altitude Headache by Visual Analogue Scale	6.4 mm Standard Deviation 10.5	7.2 mm Standard Deviation 10.5

SECONDARY outcome

Timeframe: Blood Oxygen Saturation: baseline, 24 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in Blood Oxygen Saturation	10.8 % oxygen saturation Standard Deviation 4.3	11.1 % oxygen saturation Standard Deviation 4.3

SECONDARY outcome

Timeframe: Fluid Balance: baseline, 24 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Urine output was recorded by 24 hour urine collection and fluid intake by 24 hour food diaries. Fluid balance was calculated as: (urine output (L) / fluid intake (L) ) \* 100.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in Fluid Balance	342 % of fluid intake Standard Deviation 109	147 % of fluid intake Standard Deviation 85

SECONDARY outcome

Timeframe: Optic Nerve Sheath Diameter: baseline, 3 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in Optic Nerve Sheath Diameter	0.00 mm Standard Deviation 0.06	-0.01 mm Standard Deviation 0.06

SECONDARY outcome

Timeframe: Optic Nerve Sheath Diameter: baseline, 12 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in Optic Nerve Sheath Diameter	0.01 mm Standard Deviation 0.04	0.01 mm Standard Deviation 0.04

SECONDARY outcome

Timeframe: Optic Nerve Sheath Diameter: baseline, 36 hours.

Population: All participants were included. Analysis was intention to treat. There were no missing data.

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurements. 36 hours is defined at the 36 hour hypoxia measurement.

Outcome measures

Outcome measures
Measure	Acetazolamide n=11 Participants Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Placebo n=12 Participants Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Change in Optic Nerve Sheath Diameter	0.01 mm Standard Deviation 0.04	0.00 mm Standard Deviation 0.04

Adverse Events

Acetazolamide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Justin Stevan Lawley

UWalesBangor

Phone: 00441248382810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place