Clinical trial NCT01723904: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Parkinson's Disease
Keywords: Rotigotine
Neupro
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2012-11-08
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period
timeFrame: Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
measure: 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
timeFrame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
measure: 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
timeFrame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
measure: Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off"
timeFrame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Secondary outcomes:
measure: Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia
timeFrame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
measure: Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score
timeFrame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
measure: Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score
timeFrame: From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Other outcomes:
Locations:
city: Chatswood
country: Australia
facility: 402
state: New South Wales
city: Sydney
country: Australia
facility: 401
state: New South Wales
city: Melbourne
country: Australia
facility: 403
state: Victoria
city: Busan
country: Korea, Republic of
facility: 104
city: Busan
country: Korea, Republic of
facility: 112
city: Daegu
country: Korea, Republic of
facility: 109
city: Gyeonggi-Do
country: Korea, Republic of
facility: 111
city: Seoul
country: Korea, Republic of
facility: 101
city: Seoul
country: Korea, Republic of
facility: 102
city: Seoul
country: Korea, Republic of
facility: 103
city: Seoul
country: Korea, Republic of
facility: 105
city: Seoul
country: Korea, Republic of
facility: 107
city: Seoul
country: Korea, Republic of
facility: 108
city: Seoul
country: Korea, Republic of
facility: 110
city: Kuala Terengganu
country: Malaysia
facility: 202
city: Kuching Sarawak
country: Malaysia
facility: 204
city: Pulau Pinang
country: Malaysia
facility: 201
city: Singapore
country: Singapore
facility: 501
city: Singapore
country: Singapore
facility: 502
city: Taichung
country: Taiwan
facility: 302
city: Tainan
country: Taiwan
facility: 303
city: Taipei
country: Taiwan
facility: 306
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Kim JM, Chung SJ, Kim JW, Jeon BS, Singh P, Thierfelder S, Ikeda J, Bauer L; Asia Pacific Rotigotine Add-on Study Group. Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study. BMC Neurol. 2015 Feb 28;15:17. doi: 10.1186/s12883-015-0267-7.