Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Takeda
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00507546
First received: July 25, 2007
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: September 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Insomnia
Spinal Cord Injury
Tetraplegia
Sleep Disorders
Interventions: Drug: Ramelteon
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from community

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects excluded if baseline measure detected the presence of melatonin metabolite in their urine.

Reporting Groups
  Description
Arm 1

Ramelteon then placebo

Ramelteon : 8 mg nightly

Arm 2

Placebo then ramelteon

Placebo : Nightly 8mg of placebo (same appearance as ramelteon)


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     4     4  
COMPLETED     2     3  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 0  
Protocol Violation                 1                 0  
Physician Decision                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1

Ramelteon then placebo

Ramelteon : 8 mg nightly

Arm 2

Placebo then ramelteon

Placebo : Nightly 8mg of placebo (same appearance as ramelteon)

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  4     4     8  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     4     8  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  51.25  ± 9.74     55.5  ± 15.5     53  ± 12  
Gender  
[units: participants]
     
Female     0     1     1  
Male     4     3     7  
Region of Enrollment  
[units: participants]
     
United States     4     4     8  



  Outcome Measures
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1.  Primary:   Amount of Wakefulness After Sleep Onset (WASO)   [ Time Frame: 10 weeks ]

2.  Secondary:   Change in Subjective Morning Alertness   [ Time Frame: 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jamie Zeitzer
Organization: VAPAHCS
phone: 6504935000 ext 62410
e-mail: jzeitzer@stanford.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00507546     History of Changes
Other Study ID Numbers: B6010-R, 06-038R
Study First Received: July 25, 2007
Results First Received: September 13, 2013
Last Updated: April 25, 2014
Health Authority: United States: Federal Government