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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.

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 26, 2012
Results First Submitted Date  ICMJE February 3, 2014
Results First Posted Date  ICMJE April 23, 2014
Last Update Posted Date April 23, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
  • The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters [ Time Frame: Up to 54 weeks ]
    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
  • Augmentation [ Time Frame: Up to 53 weeks ]
    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).
  • Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit [ Time Frame: Baseline, Up to 53 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
the incidence and severity of adverse events, vital signs, and laboratory parameters [ Time Frame: Up to 53 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
  • Change of IRLS Sum Score From the Baseline to Each Visit [ Time Frame: Baseline, Up to 53 weeks ]
    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 [ Time Frame: Baseline, Up to 53 weeks ]
    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 [ Time Frame: Baseline, Up to 52 weeks ]
    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 [ Time Frame: Baseline, Up to 53 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Change of IRLS sum score from the baseline to each visit [ Time Frame: Up to 53 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
Official Title  ICMJE An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Restless Legs Syndrome
Intervention  ICMJE Drug: SPM 962
Tansdermal patch
Other Name: rotigotine
Study Arms  ICMJE Experimental: SPM 962
Rotigotine transdermal patch
Intervention: Drug: SPM 962
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
185
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562743
Other Study ID Numbers  ICMJE 243-07-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP