A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Idiopathic Parkinson's Disease
Intervention: Rotigotine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB BIOSCIENCES GmbH Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
Summary
The purpose of this study is to assess the safety and feasibility of switching subjects with
advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess
the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects
switched from previous treatment with either Pramipexole or Ropinirole.
Clinical Details
Official title: An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
Secondary outcome: Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject has idiopathic Parkinson's Disease of more than 3 years duration, as defined
by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following:
resting tremor, rigidity, impairment of postural reflexes and is without any other
known or suspected cause of Parkinsonism
- Subject has motor fluctuations
- Subject is not satisfactorily controlled following the investigatorĀ“s assessment on a
total daily dose of Pramipexole or Ropinirole
- Subject has sleep disturbance or early morning motor impairment
- Subject has experienced nocturia for at least 3 nights within 7 days prior to the
Baseline Visit
- Subject is taking L-dopa in combination with Benserazide or Carbidopa and has been on
a stable dose of L-dopa for at least 28 days prior to the Baseline Visit
Exclusion Criteria:
- Subject has had 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, monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or
amphetamine
- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in
the 6 months prior to Baseline (Visit 2)
- Subject has a history of significant skin hypersensitivity to adhesive or other
transdermal preparations, or recent unsolved contact dermatitis
- Subject has a history of seizures or stroke within 1 year, or a history of myocardial
infarction within the last 6 months prior to enrollment
- Subject is pregnant or nursing, or is of childbearing potential but (i) not
surgically sterile or (ii) not using adequate birth control methods (including at
least 1 barrier method) or (iii) not sexually abstinent or (iv) not at least 2 years
postmenopausal
- Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs
syndrome, or periodic limb movement disorder
Locations and Contacts
101, Busan, Korea, Republic of
102, Busan, Korea, Republic of
108, Daegu, Korea, Republic of
109, Daegu, Korea, Republic of
105, Gyeonggi-Do, Korea, Republic of
103, Seoul, Korea, Republic of
104, Seoul, Korea, Republic of
106, Seoul, Korea, Republic of
107, Seoul, Korea, Republic of
202, Sarawak, Malaysia
401, Singapore, Singapore
403, Singapore, Singapore
301, Linkou, Taiwan
304, Taichung, Taiwan
305, Taipei, Taiwan
505, Anniston, Alabama, United States
506, Atlantis, Florida, United States
508, Miami Springs, Florida, United States
502, Atlanta, Georgia, United States
501, Dayton, Ohio, United States
509, Oklahoma City, Oklahoma, United States
Additional Information
FDA Safety Alerts and Recalls Product Information
Starting date: September 2012
Last updated: February 25, 2014
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