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

Advanced Idiopathic Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711866
• Other study ID #: PD0009
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2012
• Last updated: February 25, 2014
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2014
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)Taiwan : Food and Drug AdministrationMalaysia: Ministry of HealthSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Rotigotine
Rotigotine up to 16 mg / 24 hours, 4 weeks.

Locations

Country	Name	City	State
Korea, Republic of	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
Malaysia	202	Sarawak
Singapore	401	Singapore
Singapore	403	Singapore
Taiwan	301	Linkou
Taiwan	304	Taichung
Taiwan	305	Taipei
United States	505	Anniston	Alabama
United States	502	Atlanta	Georgia
United States	506	Atlantis	Florida
United States	501	Dayton	Ohio
United States	508	Miami Springs	Florida
United States	509	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
UCB BIOSCIENCES GmbH	Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Malaysia,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit	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.	Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit	No
Secondary	Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit	The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.	Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit	No

External Links

•   FDA Safety Alerts and Recalls
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