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
Secondary identifying numbers	N/A

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

Study design	Single centre, randomised, two-armed, placebo controlled, participants/outcome assessor blind, clinical trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sumatriptan succinate
Primary outcome measure	AMS development due to Lake Louise criteria within 24 hours (International Hypoxia Symposium)
Secondary outcome measures	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
Overall study start date	01/01/2006
Completion date	30/11/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

Imam Neurology Research Center (Iran)
Research organisation

Tehran University of Medical Sciences
No. 23, Dameshgh Street
Vali-e Asr Street
Tehran
14167
Iran

Website	http://iro.tums.ac.ir/
"ROR"	https://ror.org/01c4pz451

University/education

Imam Neurology Research Center, Tehran University of Medical Sciences (Iran)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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