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

NCT ID: NCT01562743

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-10-31

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.

Conditions

Idiopathic Restless Legs Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPM 962

Rotigotine transdermal patch

Group Type: EXPERIMENTAL

SPM 962

Intervention Type: DRUG

Tansdermal patch

Interventions

SPM 962

Tansdermal patch

Intervention Type: DRUG

Other Intervention Names

rotigotine

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 23103551 (View on PubMed)

Other Identifiers

243-07-004

Identifier Type: -

Identifier Source: org_study_id