A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
Primary Purpose
Idiopathic Restless Legs Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SPM 962
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria:
- Subject completed the preceding trial 243-07-003 (NCT00666965)
Exclusion Criteria:
- Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
- Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
- Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003.
- Subject had persistent hallucination or delusion during trial 243-07-003.
- Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
- Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline.
- Subject had a history of epilepsy, convulsion etc. during trial 243-07-003.
- Subject developed serious ECG abnormality at the baseline.
- Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-003.
- Subject had a total bilirubin ≥ 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 IU/L) at the end of the period in trial 243-07-003.
- Subject had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003.
- Subject who planned pregnancy during the trial.
- Subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPM 962
Arm Description
Rotigotine transdermal patch
Outcomes
Primary Outcome Measures
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
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:
sudden onset of sleep
obsessive-compulsive disorder or impulse-control disorder
hallucination, delusion
Augmentation
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:
Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;
Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation;
Need to change the treatment dose or the patient needs to take the dose earlier in the day (e.g., dividing the dose);
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);
Any other aspect as judged by the evaluator (should be specified).
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
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.
Secondary Outcome Measures
Change of IRLS Sum Score From the Baseline to Each Visit
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.
Efficacy Rate in IRLS Sum Score
Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
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.
Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
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.
Full Information
NCT ID
NCT01562743
First Posted
March 22, 2012
Last Updated
March 26, 2014
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01562743
Brief Title
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
Acronym
RLS
Official Title
An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Restless Legs Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPM 962
Arm Type
Experimental
Arm Description
Rotigotine transdermal patch
Intervention Type
Drug
Intervention Name(s)
SPM 962
Other Intervention Name(s)
rotigotine
Intervention Description
Tansdermal patch
Primary Outcome Measure Information:
Title
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Description
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:
sudden onset of sleep
obsessive-compulsive disorder or impulse-control disorder
hallucination, delusion
Time Frame
Up to 54 weeks
Title
Augmentation
Description
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:
Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;
Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation;
Need to change the treatment dose or the patient needs to take the dose earlier in the day (e.g., dividing the dose);
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);
Any other aspect as judged by the evaluator (should be specified).
Time Frame
Up to 53 weeks
Title
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
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
Secondary Outcome Measure Information:
Title
Change of IRLS Sum Score From the Baseline to Each Visit
Description
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
Title
Efficacy Rate in IRLS Sum Score
Description
Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
Time Frame
Baseline, Up to 53 weeks
Title
Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
Description
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
Title
Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject completed the preceding trial 243-07-003 (NCT00666965)
Exclusion Criteria:
Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003.
Subject had persistent hallucination or delusion during trial 243-07-003.
Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline.
Subject had a history of epilepsy, convulsion etc. during trial 243-07-003.
Subject developed serious ECG abnormality at the baseline.
Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-003.
Subject had a total bilirubin ≥ 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 IU/L) at the end of the period in trial 243-07-003.
Subject had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003.
Subject who planned pregnancy during the trial.
Subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.
12. IPD Sharing Statement
Citations:
PubMed Identifier
23103551
Citation
Inoue Y, Hirata K, Hayashida K, Hattori N, Tomida T, Garcia-Borreguero D; Rotigotine Study Group. Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Jan 10;40:326-33. doi: 10.1016/j.pnpbp.2012.10.012. Epub 2012 Oct 25.
Results Reference
derived
Learn more about this trial
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
We'll reach out to this number within 24 hrs