NCT00507546

Brief Summary

The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 22, 2014

Completed
Last Updated

May 22, 2014

Status Verified

April 1, 2014

Enrollment Period

3.4 years

First QC Date

July 25, 2007

Results QC Date

September 13, 2013

Last Update Submit

April 25, 2014

Conditions

InsomniaSpinal Cord InjuryTetraplegiaSleep Disorders

Keywords

sleepmelatoninspinal cord injuryinsomniatetraplegia

Outcome Measures

Primary Outcomes (1)

  • Amount of Wakefulness After Sleep Onset (WASO)

    Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment

    10 weeks

Secondary Outcomes (1)

  • Change in Subjective Morning Alertness

    10 weeks

Study Arms (2)

Ramelteon then placebo

EXPERIMENTAL

8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)

Drug: Ramelteon

Placebo then ramelteon

EXPERIMENTAL

placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)

Drug: Placebo

Interventions

RamelteonDRUG

8 mg nightly

Also known as: Rozerem
Ramelteon then placebo
PlaceboDRUG

Nightly 8mg of placebo (same appearance as ramelteon)

Placebo then ramelteon

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older, male or female veterans of any racial or ethnic group
  • Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord
  • Absence of melatonin production
  • Time since SCI is greater than 6 months \[no cases of acute spinal cord injury\]
  • Subjective complaint of sleep disruption

You may not qualify if:

  • Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial), ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) \[these interact with the same liver enzyme that is the primary metabolizer of ramelteon\]; use of sleep medications is okay
  • Hepatic dysfunction
  • Concomitant use of over-the-counter melatonin
  • Pregnancy or breast feeding
  • Currently or have within the past six months met DSM-IV (Diagnosis and Statistical Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score \>19
  • Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable.
  • No travel across three or more time zones within three weeks or during the protocol
  • Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

Related Publications (1)

  • Zeitzer JM, Ku B, Ota D, Kiratli BJ. Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia. J Spinal Cord Med. 2014 Jan;37(1):46-53. doi: 10.1179/2045772313Y.0000000099. Epub 2013 Oct 24.

    PMID: 24090266RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSpinal Cord InjuriesQuadriplegiaSleep Wake Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Jamie Zeitzer
Organization
VAPAHCS
jzeitzer@stanford.edu
6504935000

Study Officials

  • Jamie M. Zeitzer, PhD

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 26, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

May 22, 2014

Results First Posted

May 22, 2014

Record last verified: 2014-04

Locations

US(1)