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A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)

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ClinicalTrials.gov Identifier: NCT01562743
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Restless Legs Syndrome
Intervention Drug: SPM 962
Enrollment 185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SPM 962
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Rotigotine transdermal patch

A patch containing 2.25 - 6.75mg of rotigotine was administered once a day.
Period Title: Overall Study
Started 185
Completed 133
Not Completed 52
Reason Not Completed
Adverse Event             29
Lack of Efficacy             3
Withdrawal by Subject             13
Protocol Violation             1
Discontinuation criteria             2
Lost to Follow-up             2
Physician Decision             2
Arm/Group Title SPM 962
Hide Arm/Group Description Rotigotine transdermal patch
Overall Number of Baseline Participants 185
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants
<=18 years
0
   0.0%
Between 18 and 65 years
157
  84.9%
>=65 years
28
  15.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants
49.8  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants
Female
113
  61.1%
Male
72
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 185 participants
185
1.Primary Outcome
Title The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
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The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.

AEs of special interest (1-3) are defined as below:

  1. sudden onset of sleep
  2. obsessive-compulsive disorder or impulse-control disorder
  3. hallucination, delusion
Time Frame Up to 54 weeks
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Safety set (SS)
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 185
Measure Type: Number
Unit of Measure: participants
Any AEs 175
Treatment-related AEs 139
SAEs 5
Treatment-related SAEs 1
Severe AEs 3
Discontinuation due to AEs 29
Death 0
AEs of special interest 1 0
AEs of special interest 2 0
AEs of special interest 3 0
Valvular disease of the heart 0
2.Primary Outcome
Title Augmentation
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Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity.

Augmentation is clinically significant when at least one of the following occurs:

  1. Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;
  2. Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation;
  3. Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);
  4. Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);
  5. Any other aspect as judged by the evaluator (should be specified).
Time Frame Up to 53 weeks
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SS
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 185
Measure Type: Number
Unit of Measure: participants
Subjects with augmentation 11
Subjects with clinically significant augmentation 5
3.Primary Outcome
Title Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
Hide Description PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement.
Time Frame Baseline, Up to 53 weeks
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FAS, LOCF
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 182
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 8 -2.2  (3.3)
Week 16 -2.2  (2.9)
Week 44 -2.0  (3.1)
4.Secondary Outcome
Title Change of IRLS Sum Score From the Baseline to Each Visit
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IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).

The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.
Time Frame Baseline, Up to 53 weeks
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Full analysis set (FAS), last observation carried forward (LOCF)
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Weeks 8 -11.4  (8.8)
Week 16 -9.7  (9.6)
Week 32 -9.5  (9.1)
Week 44 -10.4  (9.1)
5.Secondary Outcome
Title Efficacy Rate in IRLS Sum Score
Hide Description Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
Time Frame Baseline, Up to 53 weeks
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FAS, LOCF
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 184
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Weeks 8
64.1
(57.2 to 71.1)
Week 16
54.9
(47.7 to 62.1)
Week 32
57.6
(50.5 to 64.7)
Week 44
60.3
(53.3 to 67.4)
6.Secondary Outcome
Title Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
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ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24).

A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Time Frame Baseline, Up to 52 weeks
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Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 8 1.4  (2.5)
Week 16 1.4  (2.6)
Week 32 1.6  (2.7)
Week 44 1.4  (2.6)
7.Secondary Outcome
Title Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
Hide Description SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.
Time Frame Baseline, Up to 53 weeks
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Hide Analysis Population Description
FAS, LOCF
Arm/Group Title SPM 962
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Rotigotine transdermal patch
Overall Number of Participants Analyzed 182
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Physical functioning -0.2  (8.0)
Role physical 3.7  (17.4)
Bodily pain 5.1  (22.3)
General health 1.8  (12.8)
Vitality 4.9  (15.8)
Social functioning 3.0  (16.2)
Role emotional 5.6  (14.5)
Time Frame 53 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPM 962
Hide Arm/Group Description Rotigotine transdermal patch
All-Cause Mortality
SPM 962
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
SPM 962
Affected / at Risk (%) # Events
Total   5/185 (2.70%)    
Eye disorders   
Cataract * 1  1/185 (0.54%)  1
Gastrointestinal disorders   
Diverticulitis Intestinal Haemorrhagic * 1  1/185 (0.54%)  1
General disorders   
Application Site Discolouration * 1  1/185 (0.54%)  1
Injury, poisoning and procedural complications   
Contusion * 1  1/185 (0.54%)  1
Neck Crushing * 1  1/185 (0.54%)  1
Nerve Root Injury Lumbar * 1  1/185 (0.54%)  1
Traffic Accident * 1  1/185 (0.54%)  1
Vascular disorders   
Haematoma * 1  1/185 (0.54%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)J
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
SPM 962
Affected / at Risk (%) # Events
Total   165/185 (89.19%)    
Gastrointestinal disorders   
Nausea * 1  53/185 (28.65%)  79
Vomiting * 1  15/185 (8.11%)  26
Diarrhoea * 1  12/185 (6.49%)  12
Abdominal Pain Upper * 1  10/185 (5.41%)  11
General disorders   
Application Site Reaction * 1  85/185 (45.95%)  94
Application Site Pruritus * 1  12/185 (6.49%)  13
Application Site Erythema * 1  6/185 (3.24%)  6
Infections and infestations   
Nasopharyngitis * 1  97/185 (52.43%)  186
Influenza * 1  6/185 (3.24%)  6
Injury, poisoning and procedural complications   
Fall * 1  11/185 (5.95%)  11
Contusion * 1  8/185 (4.32%)  8
Investigations   
Blood Creatine Phosphokinase Increased * 1  6/185 (3.24%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  10/185 (5.41%)  10
Nervous system disorders   
Headache * 1  25/185 (13.51%)  34
Dizziness * 1  8/185 (4.32%)  12
Psychiatric disorders   
Somnolence * 1  29/185 (15.68%)  33
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Tract Inflammation * 1  9/185 (4.86%)  11
Skin and subcutaneous tissue disorders   
Eczema * 1  9/185 (4.86%)  10
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)J
[Not Specified]
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
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Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
Phone: +81-6361-7366
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01562743    
Other Study ID Numbers: 243-07-004
First Submitted: March 22, 2012
First Posted: March 26, 2012
Results First Submitted: February 3, 2014
Results First Posted: April 23, 2014
Last Update Posted: April 23, 2014