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

Otsuka

Status and phase

Completed

Phase 2

Conditions

Idiopathic Restless Legs Syndrome

Treatments

Drug: SPM 962

Study type

Interventional

Funder types

Industry

Identifiers

NCT01562743

243-07-004

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No 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.