NCT02180451|Unknown
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Sponsor study identifier
observational
8
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 9, 2014
Actual (reported)July 2, 2014
Actual (reported)January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Circadian melatonin rhythm as measured by plasma melatonin
36-hour blood sampling on week 1
Circadian melatonin rhythm as measured by plasma melatonin
36-hour blood sampling on week 2
Circadian melatonin rhythm as measured by plasma melatonin
36-hour blood sampling on week 4
Circadian cortisol rhythms as measured by plasma cortisol
36-hour blood sampling at week 1
Circadian cortisol rhythms as measured by plasma cortisol
36-hour blood sampling at week 2
Circadian cortisol rhythms as measured by plasma cortisol
36-hour blood sampling at week 4
Circadian analytes rhythms as measured in plasma
36-hour blood sampling at week 1
Circadian analytes rhythms as measured in plasma
36-hour blood sampling at week 2
Circadian analytes rhythms as measured in plasma
36-hour blood sampling at week 4
Genetic testing to confirm SMS diagnosis
blood sampling at screening visit
Nighttime and daytime sleep as measured by actigraphy
Four week evaluation period
QOL Scale
Four week evaluation period
Melatonin Light Response Test (MLRT)
After four week evaluation period
Behavioral Scale
Four week evaluation period
Smith-Magenis patients
Baltimore, Maryland, United States
Melatonin and Cortisol samples will be collected
8 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2014
First Posted
July 2, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
Contact the study team to confirm eligibility.
Primary Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 25, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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