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Trial record 15 of 27 for:    PDSS2

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01723904
Recruitment Status : Completed
First Posted : November 8, 2012
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Brief Summary:
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.

Condition or disease Intervention/treatment Phase
Advanced Parkinson's Disease Drug: Rotigotine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B
Study Start Date : October 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rotigotine

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Drug: Rotigotine
Application of Rotigotine up to 8 mg/24 h patches for 24 hours.
Other Name: Neupro




Primary Outcome Measures :
  1. Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period [ Time Frame: Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]

    The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable

    1. = No side effects
    2. = Side effects do not significantly interfere with subject's functioning
    3. = Side effects significantly interfere with the subject's functioning
    4. = Side effects outweigh therapeutic efficacy.

  2. Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III ("on" State) Total Score [ Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]

    The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.

    A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.


  3. Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of "on" and "Off" State) Total Score [ Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]

    UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).

    UPDRS Part II total score (average of "on" and "off" state) is the average of UPDRS Part II total score ("on" state) and Part II total score ("off" state).

    A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.


  4. Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off" [ Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]

    Absolute time spent "off" is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent "off" decreased from Baseline and therefore indicates an improvement from Baseline.

    Only subjects with time spent "off" at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.



Secondary Outcome Measures :
  1. Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia [ Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]
    Absolute time spent "on" without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent "on" without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline.

  2. Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score [ Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]

    The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.

    A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.


  3. Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score [ Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) ]

    The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.

    A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.




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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female, aged ≥ 30 and < 80 years at informed consent
  • Subject has idiopathic Parkinson's Disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, and the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of Parkinsonism
  • Subject has motor fluctuations such as wearing, dyskinesia
  • Subject has experienced nocturias for at least 3 nights within 7 days prior to Baseline
  • Subject is taking levodopa (L-DOPA, immediate and/or controlled release) in combination with benserazide or carbidopa and has been on a stable dose of L-DOPA for at least 28 days prior to Baseline (Visit 2)
  • Subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least 28 days prior to Baseline (Visit 2)

Exclusion Criteria:

  • Subject is receiving therapy with tolcapone or budipine
  • Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine
  • Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within the 6 months prior to Baseline (Visit 2)
  • Subject has a known hypersensitivity to any components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis
  • Subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not surgically sterile, or, (ii) not using adequate birth control methods [including at least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2 years post menopausal)
  • Subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723904


Locations
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Australia, New South Wales
402
Chatswood, New South Wales, Australia
401
Sydney, New South Wales, Australia
Australia, Victoria
403
Melbourne, Victoria, Australia
Korea, Republic of
104
Busan, Korea, Republic of
112
Busan, Korea, Republic of
109
Daegu, Korea, Republic of
111
Gyeonggi-Do, Korea, Republic of
101
Seoul, Korea, Republic of
102
Seoul, Korea, Republic of
103
Seoul, Korea, Republic of
105
Seoul, Korea, Republic of
107
Seoul, Korea, Republic of
108
Seoul, Korea, Republic of
110
Seoul, Korea, Republic of
Malaysia
202
Kuala Terengganu, Malaysia
204
Kuching Sarawak, Malaysia
201
Pulau Pinang, Malaysia
Singapore
501
Singapore, Singapore
502
Singapore, Singapore
Taiwan
302
Taichung, Taiwan
303
Tainan, Taiwan
306
Taipei, Taiwan
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB BIOSCIENCES GmbH
ClinicalTrials.gov Identifier: NCT01723904     History of Changes
Other Study ID Numbers: PD0015
First Posted: November 8, 2012    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
Rotigotine
Neupro
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Ropinirole
Rotigotine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents