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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01723904




Registration number
NCT01723904
Ethics application status
Date submitted
6/11/2012
Date registered
8/11/2012
Date last updated
3/06/2014

Titles & IDs
Public title
A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
Scientific title
An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B
Secondary ID [1] 0 0
PD0015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rotigotine

Experimental: Rotigotine - - Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.
Duration of the Titration Period: Between 1 week and 5 weeks.
- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.
Duration of the Maintenance Period: Between 3 weeks and 7 weeks.


Treatment: Drugs: Rotigotine
Application of Rotigotine up to 8 mg/24 h patches for 24 hours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period
Timepoint [1] 0 0
Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Primary outcome [2] 0 0
Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III ("on" State) Total Score
Timepoint [2] 0 0
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Primary outcome [3] 0 0
Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of "on" and "Off" State) Total Score
Timepoint [3] 0 0
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Primary outcome [4] 0 0
Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off"
Timepoint [4] 0 0
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Secondary outcome [1] 0 0
Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia
Timepoint [1] 0 0
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Secondary outcome [2] 0 0
Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score
Timepoint [2] 0 0
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Secondary outcome [3] 0 0
Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score
Timepoint [3] 0 0
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Eligibility
Key inclusion criteria
- Subject is male or female, aged = 30 and < 80 years at informed consent

- Subject has idiopathic Parkinson's Disease, of more than 3 years duration, as defined
by the cardinal sign, bradykinesia, and the presence of at least 1 of the following:
resting tremor, rigidity, impairment of postural reflexes, and without any known or
suspected cause of Parkinsonism

- Subject has motor fluctuations such as wearing, dyskinesia

- Subject has experienced nocturias for at least 3 nights within 7 days prior to
Baseline

- Subject is taking levodopa (L-DOPA, immediate and/or controlled release) in
combination with benserazide or carbidopa and has been on a stable dose of L-DOPA for
at least 28 days prior to Baseline (Visit 2)

- Subject is taking a non-ergot dopamine agonist (pramipexole = 1.5 mg/day or ropinirole
= 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least
28 days prior to Baseline (Visit 2)
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is receiving 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 (except specific atypical neuroleptics: olanzapine,
ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A)
inhibitors, methylphenidate, or amphetamine

- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within
the 6 months prior to Baseline (Visit 2)

- Subject has a known hypersensitivity to any components of the study medication, such
as a history of significant skin hypersensitivity to adhesives, known hypersensitivity
to other transdermal medications, or has unresolved contact dermatitis

- Subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not
surgically sterile, or, (ii) not using adequate birth control methods [including at
least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2
years post menopausal)

- Subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs
syndrome, or periodic limb movement disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
402 - Chatswood
Recruitment hospital [2] 0 0
401 - Sydney
Recruitment hospital [3] 0 0
403 - Melbourne
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Busan
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Daegu
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Gyeonggi-Do
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Malaysia
State/province [5] 0 0
Kuala Terengganu
Country [6] 0 0
Malaysia
State/province [6] 0 0
Kuching Sarawak
Country [7] 0 0
Malaysia
State/province [7] 0 0
Pulau Pinang
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taichung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Tainan
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB BIOSCIENCES GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Otsuka Pharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low
doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD)
who have insufficient response to L-dopa and low doses dopamine receptor agonists.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01723904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries