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

ISRCTN	ISRCTN87201238
DOI	https://doi.org/10.1186/ISRCTN87201238
Protocol serial number	N/A
Sponsor	Imam Neurology Research Center (Iran)
Funder	Imam Neurology Research Center, Tehran University of Medical Sciences (Iran)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sirous Jafarian
Scientific

No15, Shabtab Street
Gheytarieh Avenue
Tehran
19389
Iran

Primary study design	Interventional
Study design	Single centre, randomised, two-armed, placebo controlled, participants/outcome assessor blind, clinical trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SAMS
Study objectives	Prophylaxis with sumatriptan will slow or stop the progression of acute mountain sickness (AMS) compared to those taking a placebo.
Ethics approval(s)	Institutional Review Board of Neurology Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Health condition(s) or problem(s) studied	Acute mountain sickness
Intervention	1. Sumatriptan succinate 50 mg plus orally, once at early ascent 2. Placebo: similar color, shape, and weight to interventional group
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sumatriptan succinate
Primary outcome measure(s)	AMS development due to Lake Louise criteria within 24 hours (International Hypoxia Symposium)
Key secondary outcome measure(s)	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
Completion date	30/11/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	102
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	30/11/2006

No15, Shabtab Street

Tehran
19389
Iran

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/09/2007		Yes	No