Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/11/2006
Date assigned
14/12/2006
Last edited
07/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sirous Jafarian

ORCID ID

Contact details

No15
Shabtab Street
Gheytarieh Avenue
Tehran
19389
Iran

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

http://iro.tums.ac.ir/

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

  1. 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.

Additional files

Editorial Notes