A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01562743
First received: March 22, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Restless Legs Syndrome |
Drug: SPM 962 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Restless Legs
Drug Information available for:
Rotigotine
U.S. FDA Resources
Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- the incidence and severity of adverse events, vital signs, and laboratory parameters [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Change of IRLS sum score from the baseline to each visit [ Time Frame: Up to 53 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 185 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SPM 962
Rotigotine transdermal patch
|
Drug: SPM 962
Tansdermal patch
Other Name: rotigotine
|
Eligibility| Ages Eligible for Study: | 20 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided by Otsuka Pharmaceutical Co., Ltd.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Otsuka Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01562743 History of Changes |
| Other Study ID Numbers: | 243-07-004 |
| Study First Received: | March 22, 2012 |
| Last Updated: | March 22, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations |
Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013