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

Phase 2

Completed

Conditions: Idiopathic Restless Legs Syndrome

Interventions: Drug: SPM 962

Registration Number: NCT01562743

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 185

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPM 962	SPM 962	Rotigotine transdermal patch

Primary Outcome Measures

Name	Time	Method
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change of IRLS Sum Score From the Baseline to Each Visit	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	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	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	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.