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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

Page last updated: August 23, 2015

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