Clinical trial NCT01562743: A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Restless Legs Syndrome
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 185
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
timeFrame: Up to 54 weeks
measure: Augmentation
timeFrame: Up to 53 weeks
measure: Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
timeFrame: Baseline, Up to 53 weeks
Secondary outcomes:
measure: Change of IRLS Sum Score From the Baseline to Each Visit
timeFrame: Baseline, Up to 53 weeks
measure: Efficacy Rate in IRLS Sum Score
timeFrame: Baseline, Up to 53 weeks
measure: Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
timeFrame: Baseline, Up to 52 weeks
measure: Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
timeFrame: Baseline, Up to 53 weeks
Other outcomes:
Locations:
Study officials:
References:
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.