search
Back to results

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
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Restless Legs Syndrome

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 22, 2012
    Last Updated
    March 26, 2014
    Sponsor
    Otsuka Pharmaceutical Co., Ltd.
    search

    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