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Trial record 1 of 1 for:    NCT01523301
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Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

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ClinicalTrials.gov Identifier: NCT01523301
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Korea Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE January 27, 2012
First Posted Date  ICMJE February 1, 2012
Results First Submitted Date  ICMJE October 12, 2015
Results First Posted Date  ICMJE December 18, 2015
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
Change from the Baseline to the end of Maintenance Period in the score of the Hamilton Depression Scale (HAM-D) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II) [ Time Frame: 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.
  • 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) [ Time Frame: 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).
  • Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) [ Time Frame: 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).
  • 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) [ Time Frame: 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).
  • Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS) [ Time Frame: 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.
  • Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
  • Change from Baseline to the end of Maintenance Period in the score of Beck Depression Inventory (BDI-II) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Parkinson's Disease
Intervention  ICMJE
  • Drug: 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
  • Drug: Placebo

    Transdermal Patch

    Size:

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

    Subjects randomized to placebo received matching placebo patches

Study Arms  ICMJE
  • Experimental: Rotigotine
    Rotigotine, daily doses, treatment group
    Intervention: Drug: Rotigotine
  • Placebo Comparator: Placebo
    Placebo, daily doses, placebo group
    Intervention: Drug: Placebo
Publications * Chung SJ, Asgharnejad M, Bauer L, Ramirez F, Jeon B. Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson's disease. Expert Opin Pharmacother. 2016 Aug;17(11):1453-61. doi: 10.1080/14656566.2016.1202917. Epub 2016 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
380
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
266
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01523301
Other Study ID Numbers  ICMJE SP1041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Korea Co., Ltd. )
Study Sponsor  ICMJE UCB Korea Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP