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.)
Sponsor:
Collaborator:
Takeda
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00745030
First received: August 28, 2008
Last updated: April 18, 2011
Last verified: April 2011
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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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
Ramelteon (TAK-375) 8mg Tablets Ramelteon (TAK-375) 8mg tablets
Placebo 8 mg Tablets Placebo 8 mg tablets
Total Total of all reporting groups

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 ]

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


  Other Adverse Events


  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:
Thorpy MJ. Sleep disorders in Parkinson's disease. Clin Cornerstone 2004; 6 Suppl 1A:S7-15.


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