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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01723904
• Date of registration: 06/11/2012
• Prospective Registration: No
• Primary sponsor: UCB BIOSCIENCES GmbH
• 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
• Date of first enrolment: October 2012
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01723904
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Korea, Republic of, Malaysia, Singapore, Taiwan

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

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)

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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Drug: Rotigotine

Primary Outcome(s)

Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off" [Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period [Time Frame: Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

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 [Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

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 [Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

Secondary Outcome(s)

Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score [Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia [Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score [Time Frame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)]

Secondary ID(s)

PD0015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Otsuka Pharmaceutical Co., Ltd.

Results

• Results available: Yes
• Date Posted: 03/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01723904