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Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism

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ClinicalTrials.gov Identifier: NCT00745030
Recruitment Status : Terminated (Low subject recruitment and enrollment.)
First Posted : September 1, 2008
Results First Posted : November 10, 2010
Last Update Posted : April 21, 2011
Sponsor:
Collaborator:
Takeda
Information provided by:
Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions REM Behavior Disorder
Parkinsonism
Interventions Drug: Rozerem
Drug: Placebo
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets
Hide Arm/Group Description Ramelteon (TAK-375) 8mg tablets Placebo 8 mg tablets
Period Title: Overall Study
Started 1 2
Completed 1 2
Not Completed 0 0
Arm/Group Title Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets Total
Hide Arm/Group Description Ramelteon (TAK-375) 8mg tablets Placebo 8 mg tablets Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
2
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 3 participants
57  (0) 57  (7.85) 57  (7.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
0
   0.0%
1
  33.3%
Male
0
   0.0%
2
 100.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1 2 3
1.Primary Outcome
Title 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
Hide Description

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.

Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets
Hide Arm/Group Description:
Ramelteon (TAK-375) 8mg tablets
Placebo 8 mg tablets
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Changes in Mean TST, LPS, WASO (Based on PSG)
Hide Description [Not Specified]
Time Frame 8 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Changes in Clinician Global Impression Scale of Improvement (CGI-I)
Hide Description [Not Specified]
Time Frame 10 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Changes in Patient Completed Epworth Sleepiness Scale (ESS)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Changes in Beck Depression Inventory (BDI)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Changes in Patient Completed The Fatigue Severity Scale (FSS)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Changes in Physician Completed United Parkinson’s Disease Rating Scale (UPDRS)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Changes in Mini-Mental State Exam (MMSE)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Changes in The Montreal Cognitive Assessment Scale (MoCA)
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Study Terminated Due to Low Subject Recruitment and Enrollment.
Hide Description Low subject recruitment and enrollment
Time Frame [Not Specified]
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets
Hide Arm/Group Description Ramelteon (TAK-375) 8mg tablets Placebo 8 mg tablets
All-Cause Mortality
Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ramelteon (TAK-375) 8mg Tablets Placebo 8 mg Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angelica Marconi
Organization: Northwestern University
Phone: 312-503-1999
EMail: a-marconi@northwestern.edu
Publications:
Layout table for additonal information
Responsible Party: Tanya Simuni, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00745030     History of Changes
Other Study ID Numbers: 07-028R
First Submitted: August 28, 2008
First Posted: September 1, 2008
Results First Submitted: October 12, 2010
Results First Posted: November 10, 2010
Last Update Posted: April 21, 2011