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Prophylactic sumatriptan for prevention of Acute Mountain Sickness: a double blind, randomised, placebo controlled, clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87201238
Enrollment
102
Registered
2006-12-14
Start date
2006-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute mountain sickness Injury, Occupational Diseases, Poisoning Acute mountain sickness

Interventions

1. Sumatriptan succinate 50 mg plus orally, once at early ascent 2. Placebo: similar color, shape, and weight to interventional group

Sponsors

Imam Neurology Research Center (Iran)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of 18 to 60 years 2. Ascent to a high altitude of 3500 to 3900 metres above sea level from an altitude of at least 1500 metres 3. Consenting participant 4. May reasonably be expected to complete a 24 hour trial

Exclusion criteria

Exclusion criteria: 1. Other neuro-vascular disease such as cerebrovascular accident, and hypoxic cerebral damage 2. Cardiovascular disease such as ischaemic heart disease, coronary artery disease, significant valvular disease, congestive heart failure, and uncontrolled hypertension with systolic pressure greater than 180 mmHg or diastolic pressure greater than 110 mmHg 3. Pregnancy 4. Hypersensitivity to either sumatriptan or acetazolamide or their components

Design outcomes

Primary

MeasureTime frame
AMS development due to Lake Louise criteria within 24 hours (International Hypoxia Symposium)

Secondary

MeasureTime frame
1. AMS severity (score more than or equal to five) due to Lake Louise protocol after 24 hours (self-report and clinical assessment) 2. Altitude headache occurrence and severity

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026