Clinical trial NCT01711866: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro
Switch
Dopamine agonists
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2012-10-22
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 investigator´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

Primary outcomes:
measure: Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
timeFrame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Secondary outcomes:
measure: Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
timeFrame: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Other outcomes:
Locations:
city: Anniston
country: United States
facility: 505
state: Alabama
city: Atlantis
country: United States
facility: 506
state: Florida
city: Miami Springs
country: United States
facility: 508
state: Florida
city: Atlanta
country: United States
facility: 502
state: Georgia
city: Dayton
country: United States
facility: 501
state: Ohio
city: Oklahoma City
country: United States
facility: 509
state: Oklahoma
city: Busan
country: Korea, Republic of
facility: 101
city: Busan
country: Korea, Republic of
facility: 102
city: Daegu
country: Korea, Republic of
facility: 108
city: Daegu
country: Korea, Republic of
facility: 109
city: Gyeonggi-Do
country: Korea, Republic of
facility: 105
city: Seoul
country: Korea, Republic of
facility: 103
city: Seoul
country: Korea, Republic of
facility: 104
city: Seoul
country: Korea, Republic of
facility: 106
city: Seoul
country: Korea, Republic of
facility: 107
city: Sarawak
country: Malaysia
facility: 202
city: Singapore
country: Singapore
facility: 401
city: Singapore
country: Singapore
facility: 403
city: Linkou
country: Taiwan
facility: 301
city: Taichung
country: Taiwan
facility: 304
city: Taipei
country: Taiwan
facility: 305
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Chung SJ, Kim JM, Kim JW, Jeon BS, Singh P, Thierfelder S, Ikeda J, Bauer L; Asia Pacific Rotigotine Switching Study Group. Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study. Expert Opin Pharmacother. 2015 May;16(7):961-70. doi: 10.1517/14656566.2015.1030336. Epub 2015 Apr 6.