Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00522379 |
|
Recruitment Status :
Completed
First Posted : August 29, 2007
Results First Posted : December 10, 2012
Last Update Posted : October 27, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease | Drug: Rotigotine Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 514 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Rotigotine 2 mg/24 hr |
Drug: Rotigotine
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro |
| Experimental: Rotigotine 4 mg/24 hr |
Drug: Rotigotine
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro |
| Experimental: Rotigotine 6 mg/24 hr |
Drug: Rotigotine
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro |
| Experimental: Rotigotine 8 mg/24 hr |
Drug: Rotigotine
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Other Name: Neupro |
| Placebo Comparator: Placebo |
Other: Placebo
Placebo transdermal patch applied daily |
- The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
- The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
- The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.
- The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.
- The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Are "off" periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are predictable.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Are "off" periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are unpredictable.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Do "off" periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods come on suddenly, within a few seconds.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = What proportion of the waking day is the subject "off", on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is "off" a larger portion of the waking day.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]
Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.
Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
- The Change in Number of "Off" Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary [ Time Frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. ]Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- PD greater than 3 years
- Stable dose L-dopa but symptoms not adequately controlled and have "off" time
- Able and willing to complete diary on specific days
Exclusion Criteria:
- Previous use of rotigotine or Neupro
- Atypical Parkinson's syndrome
- Pallidotomy
- Thalamotomy
- Deep brain stimulation
- Fetal tissue transplant
- Dementia
- Psychosis
- Hallucinations
- Epilepsy
- Renal or hepatic dysfunction
- Clinically relevant cardiac dysfunction
- Symptomatic orthostatic hypotension
- Skin sensitivity to adhesives or unresolved contact dermatitis
- History of chronic alcohol or drug abuse
- Pregnant or of child-bearing potential
- Impulse control disorder
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522379
Show 77 study locations
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00522379 |
| Other Study ID Numbers: |
SP0921 |
| First Posted: | August 29, 2007 Key Record Dates |
| Results First Posted: | December 10, 2012 |
| Last Update Posted: | October 27, 2014 |
| Last Verified: | December 2012 |
|
Parkinson's disease rotigotine patch transdermal |
dopamine agonist off time Neupro |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Rotigotine Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |