Phase 2
N=185
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
Idiopathic Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01562743 ↗Enrolled (actual)
185
Serious AEs
2.7%
Results posted
Apr 2014
Primary outcome: Primary: The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters — 175; 139; 5; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPM 962 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters |
175; 139; 5; 1; 3; 29 | — |
| PRIMARY Augmentation |
11; 5 | — |
| PRIMARY Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit |
-2.2; -2.2; -2.0 | — |
| SECONDARY Change of IRLS Sum Score From the Baseline to Each Visit |
-11.4; -9.7; -9.5; -10.4 | — |
| SECONDARY Efficacy Rate in IRLS Sum Score |
64.1; 54.9; 57.6; 60.3 | — |
| SECONDARY Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit |
1.4; 1.4; 1.6; 1.4 | — |
| SECONDARY Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit |
-0.2; 3.7; 5.1; 1.8; 4.9; 3.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01562743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.