Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01084551
First received: March 4, 2010
Last updated: May 28, 2014
Last verified: May 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Restless Legs Syndrome
Interventions: Drug: SPM 962
Drug: Placebo of SPM 962

  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
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Reporting Groups
  Description
Placebo 0 mg/day for 13 weeks
SPM 962 4.5 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
SPM 962 6.75 started at 2.25 mg/day to 6.75 mg/day for 13 weeks

Participant Flow:   Overall Study
    Placebo     SPM 962 4.5     SPM 962 6.75  
STARTED     95     95     94  
COMPLETED     86     81     86  
NOT COMPLETED     9     14     8  
Adverse Event                 2                 9                 4  
Lack of Efficacy                 2                 0                 1  
Withdrawal by Subject                 2                 1                 0  
Protocol Violation                 2                 4                 0  
Lost to Follow-up                 0                 0                 3  
Physician Decision                 1                 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.
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Reporting Groups
  Description
Placebo 0 mg/day for 13 weeks
SPM 962 4.5 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
SPM 962 6.75 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     SPM 962 4.5     SPM 962 6.75     Total  
Number of Participants  
[units: participants]
  95     95     94     284  
Age  
[units: years]
Mean ± Standard Deviation
  53.4  ± 15.3     50.7  ± 13.3     50.9  ± 13.7     51.7  ± 14.1  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     65     77     77     219  
>=65 years     30     18     17     65  
Gender  
[units: participants]
       
Female     54     54     46     154  
Male     41     41     48     130  
Region of Enrollment  
[units: participants]
       
Japan     95     95     94     284  



  Outcome Measures
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1.  Primary:   International Restless Legs Syndrome Rating Scale (IRLS) Total Score   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

2.  Secondary:   Clinical Global Impression (CGI) Improvement   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

3.  Secondary:   Patient Global Impression (PGI) Improvement   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

4.  Secondary:   The Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

5.  Secondary:   Each Item of IRLS (10 Items)   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

6.  Secondary:   Incidence of RLS Symptoms   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

7.  Secondary:   Average Duration of RLS Symptoms   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (weeks 13) ]

8.  Secondary:   Incidence of RLS Symptoms in the Evening and Night   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

9.  Secondary:   Average Duration of RLS Symptoms in the Evening and Night in a Week   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (weeks 13) ]

10.  Secondary:   Nocturnal Awakenings Due to RLS Symptoms in a Week   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (week 13) ]

11.  Secondary:   Average Sleep Time in a Week   [ Time Frame: Baseline, the end of dose-titration/dose-maintenance period (weeks 13) ]


  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:  
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:  
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
phone: +81-3-6361-7366


No publications provided by Otsuka Pharmaceutical Co., Ltd.

Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01084551     History of Changes
Other Study ID Numbers: 243-09-001, JapicCTI-101053
Study First Received: March 4, 2010
Results First Received: February 3, 2014
Last Updated: May 28, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare