Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01723904
Other study ID # PD0015
Secondary ID
Status Completed
Phase Phase 3
First received November 6, 2012
Last updated May 7, 2014
Start date October 2012
Est. completion date April 2013

Study information

Verified date May 2014
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug SafetyMalaysia: Ministry of HealthTaiwan : Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSingapore: Health Sciences Authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia 402 Chatswood New South Wales
Australia 403 Melbourne Victoria
Australia 401 Sydney New South Wales
Korea, Republic of 104 Busan
Korea, Republic of 112 Busan
Korea, Republic of 109 Daegu
Korea, Republic of 111 Gyeonggi-Do
Korea, Republic of 101 Seoul
Korea, Republic of 102 Seoul
Korea, Republic of 103 Seoul
Korea, Republic of 105 Seoul
Korea, Republic of 107 Seoul
Korea, Republic of 108 Seoul
Korea, Republic of 110 Seoul
Malaysia 202 Kuala Terengganu
Malaysia 204 Kuching Sarawak
Malaysia 201 Pulau Pinang
Singapore 501 Singapore
Singapore 502 Singapore
Taiwan 302 Taichung
Taiwan 303 Tainan
Taiwan 306 Taipei

Sponsors (2)

Lead Sponsor Collaborator
UCB BIOSCIENCES GmbH Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
= No side effects
= Side effects do not significantly interfere with subject's functioning
= Side effects significantly interfere with the subject's functioning
= Side effects outweigh therapeutic efficacy.
Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) No
Primary 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) No
Primary 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) No
Primary 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) No
Secondary Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia Absolute time spent "on" without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent "on" without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline. From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) No
Secondary Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.
A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) No
Secondary Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.
A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.
From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) No
See also
  Status Clinical Trial Phase
Recruiting NCT02154724 - Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease N/A
Completed NCT02549092 - A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) Phase 3
Completed NCT01960842 - A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications Phase 3
Completed NCT01479127 - Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease Phase 2
Completed NCT03007888 - A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease Phase 2
Completed NCT00660673 - Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease Phase 3
Active, not recruiting NCT04802733 - Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease Phase 1
Completed NCT01736176 - A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease Phase 3
Completed NCT02082249 - An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications Phase 3
Completed NCT02611713 - Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
Terminated NCT01536015 - Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction Phase 3
Completed NCT00357994 - Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Phase 3
Completed NCT00335153 - Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease Phase 3
Active, not recruiting NCT06396494 - An Automated Navigation System for Deep Brain Electrode Implantation
Recruiting NCT06195124 - A Study on the Safety and Tolerability of RGL-193 in Patients With Advanced Parkinson's Disease Early Phase 1
Completed NCT00660387 - Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Phase 3