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A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)
An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: SPM 962
Rotigotine transdermal patch
|
Tansdermal patch
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Tijdsspanne: Up to 54 weeks
|
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:
|
Up to 54 weeks
|
Augmentation
Tijdsspanne: Up to 53 weeks
|
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:
|
Up to 53 weeks
|
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
Tijdsspanne: Baseline, Up to 53 weeks
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change of IRLS Sum Score From the Baseline to Each Visit
Tijdsspanne: Baseline, Up to 53 weeks
|
IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. |
Baseline, Up to 53 weeks
|
Efficacy Rate in IRLS Sum Score
Tijdsspanne: Baseline, Up to 53 weeks
|
Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.
|
Baseline, Up to 53 weeks
|
Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit
Tijdsspanne: Baseline, Up to 52 weeks
|
ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24). A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. |
Baseline, Up to 52 weeks
|
Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit
Tijdsspanne: Baseline, Up to 53 weeks
|
SF-36 is a scale for assessing health status in clinical practice and research.
The scores of 36 questions are summarized into 7 sub-scales.
In each sub-scale which range is 0-100, a higher score indicates a better health status.
Thus a increase in the scores means improvement.
|
Baseline, Up to 53 weeks
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Pathologische processen
- Ziekten van het zenuwstelsel
- Slaapstoornissen, intrinsiek
- Dyssomnieën
- Slaap-waakstoornissen
- Neurologische manifestaties
- Neurologische gedragsmanifestaties
- Ziekte
- Dyskinesieën
- Psychomotorische stoornissen
- Parasomnieën
- Syndroom
- Psychomotorische agitatie
- Rusteloze benen syndroom
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Dopamine-agonisten
- Dopamine-agenten
- Rotigotine
Andere studie-ID-nummers
- 243-07-004
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Klinische onderzoeken op SPM 962
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Otsuka Pharmaceutical Co., Ltd.Voltooid