NCT01711866

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

October 18, 2012

Results QC Date

February 25, 2014

Last Update Submit

February 25, 2014

Conditions

Advanced Idiopathic Parkinson's Disease

Keywords

RotigotineNeuproSwitchDopamine agonists

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit

    Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit

Study Arms (1)

Rotigotine

EXPERIMENTAL

First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period. * Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours. * Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.

Drug: Rotigotine

Interventions

RotigotineDRUG

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

Also known as: Neupro
Rotigotine

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

505

Anniston, Alabama, United States

Location

506

Atlantis, Florida, United States

Location

508

Miami Springs, Florida, United States

Location

502

Atlanta, Georgia, United States

Location

501

Dayton, Ohio, United States

Location

509

Oklahoma City, Oklahoma, United States

Location

202

Sarawak, Malaysia

Location

401

Singapore, Singapore

Location

403

Singapore, Singapore

Location

101

Busan, South Korea

Location

102

Busan, South Korea

Location

108

Daegu, South Korea

Location

109

Daegu, South Korea

Location

105

Gyeonggi-do, South Korea

Location

103

Seoul, South Korea

Location

104

Seoul, South Korea

Location

106

Seoul, South Korea

Location

107

Seoul, South Korea

Location

301

Linkou District, Taiwan

Location

304

Taichung, Taiwan

Location

305

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 25846031DERIVED

Related Links

MeSH Terms

Interventions

rotigotine

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
+1 877 822 9493

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 22, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 7, 2014

Results First Posted

April 7, 2014

Record last verified: 2014-02

Locations

SG(2)US(6)MY(1)KR(9)TW(3)