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

NCT01723904 | Completed Phase 3 Results

• 1 other identifier: PD0015
• Study Type: interventional
• Target: 90
• Locations: 5 countries
• Sites: 22

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.

Conditions

Advanced Parkinson's Disease

Keywords

Rotigotine; Neupro

Outcome Measures

Primary Outcomes (4)

• Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period

  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.

  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

  The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108. A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.

  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 II (Average of "on" and "Off" State) Total Score

  UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible). UPDRS Part II total score (average of "on" and "off" state) is the average of UPDRS Part II total score ("on" state) and Part II total score ("off" state). A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.

  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 Absolute Time Spent "Off"

  Absolute time spent "off" is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent "off" decreased from Baseline and therefore indicates an improvement from Baseline. Only subjects with time spent "off" at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.

  From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Secondary Outcomes (3)

• Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia

  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 Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score

  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

  From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)

Study Arms (1)

Rotigotine

EXPERIMENTAL

\- 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.

Drug: Rotigotine

Interventions

Rotigotine DRUG

Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Also known as: Neupro

Rotigotine

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (22)

402

Chatswood, New South Wales, Australia

Location

401

Sydney, New South Wales, Australia

Location

403

Melbourne, Victoria, Australia

Location

202

Kuala Terengganu, Malaysia

Location

204

Kuching Sarawak, Malaysia

Location

201

Pulau Pinang, Malaysia

Location

501

Singapore, Singapore

Location

502

Singapore, Singapore

Location

104

Busan, South Korea

Location

112

Busan, South Korea

Location

109

Daegu, South Korea

Location

111

Gyeonggi-do, South Korea

Location

101

Seoul, South Korea

Location

102

Seoul, South Korea

Location

103

Seoul, South Korea

Location

105

Seoul, South Korea

Location

107

Seoul, South Korea

Location

108

Seoul, South Korea

Location

110

Seoul, South Korea

Location

302

Taichung, Taiwan

Location

303

Tainan, Taiwan

Location

306

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 25879416 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

rotigotine

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 3, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-05

Locations

AU (3); MY (3); SG (2); KR (11); TW (3)