Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SAMS
Study hypothesis
Prophylaxis with sumatriptan will slow or stop the progression of acute mountain sickness (AMS) compared to those taking a placebo.
Ethics approval
Institutional Review Board of Neurology Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, 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
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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 names
Sumatriptan succinate
Primary outcome measures
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 trial start date
01/01/2006
Overall trial end date
30/11/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
102
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
30/11/2006
Locations
Countries of recruitment
Iran
Trial participating centre
No15, Shabtab Street
Tehran
19389
Iran
Sponsor information
Organisation
Imam Neurology Research Center (Iran)
Sponsor details
Tehran University of Medical Sciences
No. 23
Dameshgh Street
Vali-e Asr Street
Tehran
14167
Iran
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
Imam Neurology Research Center, Tehran University of Medical Sciences (Iran)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17557349
Publication citations
-
Results
Jafarian S, Gorouhi F, Salimi S, Lotfi J, Sumatriptan for prevention of acute mountain sickness: randomized clinical trial., Ann. Neurol., 2007, 62, 3, 273-277, doi: 10.1002/ana.21162.