A Long-Term Extension Trial From Late Phase II 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:
NCT01562743
First received: March 22, 2012
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Restless Legs Syndrome
Drug: SPM 962
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Up to 53 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 185
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPM 962
Rotigotine transdermal patch
Drug: SPM 962
Tansdermal patch
Other Name: rotigotine

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided by Otsuka Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01562743     History of Changes
Other Study ID Numbers: 243-07-004
Study First Received: March 22, 2012
Results First Received: February 3, 2014
Last Updated: March 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Dyskinesias
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Parasomnias
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 20, 2014