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Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

16 november 2015 uppdaterad av: UCB Korea Co., Ltd.

Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The study included a maximum 2-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease or maximum 7-week Titration Period for advanced-stage Parkinson's disease, 8-week Maintenance Period, a maximum 6-day De-escalation Period for early-stage Parkinson's disease or maximum 12-day De-escalation Period for advanced-stage Parkinson's disease and 30-day Safety Follow-Up Period.

The maximum study durations for an individual subject with early-stage Parkinson's disease and with advanced-stage Parkinson's disease were 19 weeks and 23 weeks, respectively.

Studietyp

Interventionell

Inskrivning (Faktisk)

380

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Korea, Republiken av
      • Ansan, Korea, Republiken av
        • 03
      • Anyang, Korea, Republiken av
        • 19
      • Busan, Korea, Republiken av
        • 08
      • Busan, Korea, Republiken av
        • 26
      • Chungbuk, Korea, Republiken av
        • 23
      • Daegu, Korea, Republiken av
        • 04
      • Daegu, Korea, Republiken av
        • 05
      • Daejon, Korea, Republiken av
        • 16
      • Goyang, Korea, Republiken av
        • 28
      • Gwangju, Korea, Republiken av
        • 24
      • Gwangju, Korea, Republiken av
        • 29
      • Gyeonggi-Do, Korea, Republiken av
        • 11
      • Jinju, Korea, Republiken av
        • 15
      • Seoul, Korea, Republiken av
        • 01
      • Seoul, Korea, Republiken av
        • 02
      • Seoul, Korea, Republiken av
        • 12
      • Seoul, Korea, Republiken av
        • 13
      • Seoul, Korea, Republiken av
        • 17
      • Seoul, Korea, Republiken av
        • 20
      • Seoul, Korea, Republiken av
        • 21
      • Seoul, Korea, Republiken av
        • 06
      • Seoul, Korea, Republiken av
        • 07
      • Seoul, Korea, Republiken av
        • 09
      • Seoul, Korea, Republiken av
        • 10
      • Seoul, Korea, Republiken av
        • 14
      • Seoul, Korea, Republiken av
        • 18
      • Seoul, Korea, Republiken av
        • 22
      • Seoul, Korea, Republiken av
        • 27
      • Yangsan, Korea, Republiken av
        • 25

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Male or female subjects ≥ 20 years old
  • Subjects diagnosed with idiopathic Parkinson's disease (according to the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's disease) at modified Hoehn and Yahr Scale stages I-III; do not have motor fluctuations, dyskinesia, and have stable motor symptom at least 4 weeks prior to the Screening Visit as judged by the local investigator
  • Subject has a Beck Depression Inventory II (BDI-II) score ≥ 16 as evidenced by depression rating scale study in Parkinson's disease (Schrag A et al, 2007)
  • Subject has a Mini-Mental State Examination (MMSE) score ≥ 24
  • If subject is taking Levodopa (L-DOPA) and derivatives, Monoamine Oxidase (MAO) B-inhibitors, anticholinergics agents, Catechol-O-Methyl Transferase (COMT) inhibitor or N-Methyl-D-Aspartate (NMDA) antagonist, he/she must have been on stable dose for at least 28 days prior to the Screening Visit
  • If subject is taking an antidepressant drug such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion, tricyclic antidepressants (TCAs), he/she must have been on a stable dose for at least 28 days prior to the Screening Visit and be maintained on that dose for the duration of the trial

Exclusion Criteria:

  • Subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening (Visit 1)
  • Current psychotherapy or behavior therapy while participating in this study
  • Subject has received electroconvulsive therapy within 12 weeks of the Screening Visit
  • Subject who has received dopamine agonists within 28 days of the Screening Visit
  • Subject who has received neuroleptics, methylphenidate, reserpine, alpha-methyldopa, metoclopramide, levosulpiride or amphetamine derivatives within 28 days of the Screening Visit

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Rotigotin
Rotigotin, dagliga doser, behandlingsgrupp
Läkemedel: Rotigotine

Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

  • For early-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 8 week Maintenance period
  • For advanced-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 8 week Maintenance period
Placebo-jämförare: Placebo
Placebo, dagliga doser, placebogrupp
Läkemedel: Placebo

Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo received matching placebo patches

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression.
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
The UPDRS Part II is a tool to measure Activities in Daily Living - it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe).
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson's disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities).
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe).
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42.
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)
Tidsram: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms.
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Samarbetspartners och utredare

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Sponsor

UCB Korea Co., Ltd.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 oktober 2014

Avslutad studie (Faktisk)

1 oktober 2014

Studieregistreringsdatum

Först inskickad

27 januari 2012

Först inskickad som uppfyllde QC-kriterierna

31 januari 2012

Första postat (Uppskatta)

1 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 december 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 november 2015

Senast verifierad

1 november 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SP1041

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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