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Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism
This study has been terminated.
( Low subject recruitment and enrollment. )
Study NCT00745030   Information provided by Northwestern University

First Received on August 28, 2008.   Last Updated on April 18, 2011   History of Changes
Results First Received: October 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: REM Behavior Disorder
Parkinsonism
Interventions: Drug: Rozerem
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ramelteon (TAK-375) 8mg Tablets Ramelteon (TAK-375) 8mg tablets
Placebo 8 mg Tablets Placebo 8 mg tablets

Participant Flow:   Overall Study
    Ramelteon (TAK-375) 8mg Tablets     Placebo 8 mg Tablets  
STARTED     1     2  
COMPLETED     1     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Ramelteon (TAK-375) 8mg Tablets Ramelteon (TAK-375) 8mg tablets
Placebo 8 mg Tablets Placebo 8 mg tablets

Baseline Measures
    Ramelteon (TAK-375) 8mg Tablets     Placebo 8 mg Tablets     Total  
Number of Participants  
[units: participants]
 		  1     2     3  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     1     2     3  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  57  ± 0     57  ± 7.85     57  ± 7.85  
Gender  
[units: participants]
 		     
Female     1     0     1  
Male     0     2     2  
Region of Enrollment  
[units: participants]
 		     
United States     1     2     3  



  Outcome Measures

1.  Primary:   Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Mean TST, LPS, WASO (Based on PSG)   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Changes in Clinician Global Impression Scale of Improvement (CGI-I)   [ Time Frame: 10 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Changes in Patient Completed Epworth Sleepiness Scale (ESS)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Changes in Beck Depression Inventory (BDI)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Changes in Patient Completed The Fatigue Severity Scale (FSS)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Changes in Physician Completed United Parkinson’s Disease Rating Scale (UPDRS)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Changes in Mini-Mental State Exam (MMSE)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

14.  Secondary:   Changes in The Montreal Cognitive Assessment Scale (MoCA)   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

15.  Secondary:   Study Terminated Due to Low Subject Recruitment and Enrollment.   [ Time Frame: N/A ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Angelica Marconi
Organization: Northwestern University
phone: 312-503-1999
e-mail: a-marconi@northwestern.edu


Publications:
Simuni T. Somnolence and other sleep disorders in Parkinson's disease: the challenge for the practicing neurologist. Neurol Clin. 2004 Oct;22(3 Suppl):S107-26. Review. No abstract available.
Thorpy MJ. Sleep disorders in Parkinson's disease. Clin Cornerstone 2004; 6 Suppl 1A:S7-15.
Gagnon JF, Bédard MA, Fantini ML, Petit D, Panisset M, Rompré S, Carrier J, Montplaisir J. REM sleep behavior disorder and REM sleep without atonia in Parkinson's disease. Neurology. 2002 Aug 27;59(4):585-9.
Schenck CH, Bundlie SR, Patterson AL, Mahowald MW. Rapid eye movement sleep behavior disorder. A treatable parasomnia affecting older adults. JAMA. 1987 Apr 3;257(13):1786-9.
Boeve BF, Silber MH, Parisi JE, Dickson DW, Ferman TJ, Benarroch EE, Schmeichel AM, Smith GE, Petersen RC, Ahlskog JE, Matsumoto JY, Knopman DS, Schenck CH, Mahowald MW. Synucleinopathy pathology and REM sleep behavior disorder plus dementia or parkinsonism. Neurology. 2003 Jul 8;61(1):40-5.
Boeve BF, Silber MH, Ferman TJ, Lucas JA, Parisi JE. Association of REM sleep behavior disorder and neurodegenerative disease may reflect an underlying synucleinopathy. Mov Disord. 2001 Jul;16(4):622-30.
Schenck CH, Bundlie SR, Mahowald MW. Delayed emergence of a parkinsonian disorder in 38% of 29 older men initially diagnosed with idiopathic rapid eye movement sleep behaviour disorder. Neurology. 1996 Feb;46(2):388-93. Erratum in: Neurology 1996 Jun;46(6):1787.
Boeve BF, Silber MH, Ferman TJ. Melatonin for treatment of REM sleep behavior disorder in neurologic disorders: results in 14 patients. Sleep Med. 2003 Jul;4(4):281-4.
Takeuchi N, Uchimura N, Hashizume Y, Mukai M, Etoh Y, Yamamoto K, Kotorii T, Ohshima H, Ohshima M, Maeda H. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001 Jun;55(3):267-9.
Kunz D, Bes F. Melatonin as a therapy in REM sleep behavior disorder patients: an open-labeled pilot study on the possible influence of melatonin on REM-sleep regulation. Mov Disord. 1999 May;14(3):507-11.
Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006 Jun;7(4):312-8. Epub 2006 May 18.
Borja NL, Daniel KL. Ramelteon for the treatment of insomnia. Clin Ther. 2006 Oct;28(10):1540-55. Review.
Chaudhuri KR, Pal S, DiMarco A, Whately-Smith C, Bridgman K, Mathew R, Pezzela FR, Forbes A, Högl B, Trenkwalder C. The Parkinson's disease sleep scale: a new instrument for assessing sleep and nocturnal disability in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):629-35.


Responsible Party: Tanya Simuni, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00745030     History of Changes
Other Study ID Numbers: 07-028R
Study First Received: August 28, 2008
Results First Received: October 12, 2010
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration





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