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

26. mars 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

185

Fase

  • Fase 2

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 79 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SPM 962
Rotigotine transdermal patch
Legemiddel: SPM 962
Tansdermal patch
Andre navn:
  • rotigotin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2008

Primær fullføring (Faktiske)

1. oktober 2010

Studiet fullført (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først innsendt

22. mars 2012

Først innsendt som oppfylte QC-kriteriene

22. mars 2012

Først lagt ut (Anslag)

26. mars 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. april 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mars 2014

Sist bekreftet

1. mars 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 243-07-004

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