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

NCT01562743 | Completed Phase 2 Results

• 1 other identifier: 243-07-004
• Study Type: interventional
• Target: 185
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters

  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

  Up to 54 weeks

• Augmentation

  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).

  Up to 53 weeks

• Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit

  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.

  Baseline, Up to 53 weeks

Secondary Outcomes (4)

• Change of IRLS Sum Score From the Baseline to Each Visit

  Baseline, Up to 53 weeks

• Efficacy Rate in IRLS Sum Score

  Baseline, Up to 53 weeks

• Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit

  Baseline, Up to 52 weeks

• Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit

  Baseline, Up to 53 weeks

Study Arms (1)

SPM 962

EXPERIMENTAL

Rotigotine transdermal patch

Drug: SPM 962

Interventions

SPM 962 DRUG

Tansdermal patch

Also known as: rotigotine

SPM 962

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject completed the preceding trial 243-07-003 (NCT00666965)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 23103551 DERIVED

MeSH Terms

Interventions

rotigotine

Results Point of Contact

• Title: Director of Clinical Research and Development
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-03