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Prophylactic Gabapentin 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
ISRCTN26123577
Enrollment
204
Registered
2007-03-27
Start date
2007-02-15
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 Mountain sickness

Interventions

Treatment group one: gabapentin 600 mg orally
single dose within first two hours of ascent. Treatment group two: mono-hydrate lactose (same shape and weight to gabapentin capsules)
single dose within first two hours of ascent.

Sponsors

Tehran University of Medical Sciences (Iran)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age of 15 to 65 years 2. Ascent to a high altitude of 3500 to 3900 metres above sea level from an altitude of at least 1500 metres using cable cars (within 45 to 90 minutes) 3. Consenting participant 4. May reasonably be expected to complete a 24 hour trial

Exclusion criteria

Exclusion criteria: 1. Severe cardiac, pulmonary, or liver disease 2. Severely impaired kidney function 3. Current history of alcohol or drug abuse 4. Pregnancy 4. Known allergy to gabapentin 5. Treatment with anticonvulsants or tricyclic antidepressants

Design outcomes

Primary

MeasureTime frame
1. AMS incidence (Lake Louise acute mountain sickness score of equal or more than three with headache and at least one other symptom) 2. AMS severity (score of five or more)

Secondary

MeasureTime frame
1. Duration of high-altitude headache free phase after prophylaxis initiation 2. Duration of moderate to severe high-altitude headache free phase after prophylaxis

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026