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

26. marts 2014 opdateret af: Otsuka Pharmaceutical Co., Ltd.

An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

185

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SPM 962
Rotigotine transdermal patch
Medicin: SPM 962
Tansdermal patch
Andre navne:
  • rotigotin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Tidsramme: 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:

  1. sudden onset of sleep
  2. obsessive-compulsive disorder or impulse-control disorder
  3. hallucination, delusion
Up to 54 weeks
Augmentation
Tidsramme: 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:

  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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of IRLS Sum Score From the Baseline to Each Visit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

22. marts 2012

Først indsendt, der opfyldte QC-kriterier

22. marts 2012

Først opslået (Skøn)

26. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 243-07-004

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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