A Phase 4 interventional study of Rotigotine and Placebo in Advanced Idiopathic Parkinson's Disease, sponsored by UCB BIOSCIENCES GmbH. Completed at 16 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-01.
Sponsored by UCB BIOSCIENCES GmbH · Phase 4, Interventional, and Treatment
This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 68 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →UCB BIOSCIENCES GmbH is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rotigotine Transdermal Patches
Drug: Rotigotine
Placebo Transdermal Patches
Drug: Placebo
Patches will contain 4 mg / 24 h (20 cm\^2), 6 mg/ 24 h (30 cm\^2), or 8 mg /24 h (40 cm\^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.
Also known as: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Placebo patches match the size of active patches 20 cm\^2, 30 cm\^2, or 40 cm\^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.
Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced). The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)
Percentage of Responders at the End of the Maintenance Period
Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)
The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)
Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease
The classification of pain in Parkinson's disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4). A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement.
Time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
The study was conducted in Europe and USA. Recruitment was planned to continue until approximately 64 patients were randomized in the study. Subjects were randomized in a 1:1 ratio to either Rotigotine or Placebo. To achieve this, approximately 28 investigational sites were planned to participate in this hypothesis-generating pilot study.
| Milestone | Placebo | Rotigotine |
|---|---|---|
| Started | 33 | 35 |
| Completed | 31 | 33 |
| Not completed | 2 | 2 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Personal reasons | 0 | 1 |
| Milestone | Placebo | Rotigotine |
|---|---|---|
| Started | 31 | 33 |
| Completed | 27 | 29 |
| Not completed | 4 | 4 |
| Withdrew: Adverse event | 1 | 3 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Subject left town | 1 | 0 |
An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced). The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.
| scores on a scale | Placebo | Rotigotine |
|---|---|---|
| Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale | -2.2 ± 2.78 | -2.8 ± 1.84 |
Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).
| percentage of responders | Placebo | Rotigotine |
|---|---|---|
| Percentage of Responders at the End of the Maintenance Period | 46.7 | 60 |
The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.
| scores on a scale | Placebo | Rotigotine |
|---|---|---|
| Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8) | -3.77 ± 13.93 | -12.40 ± 19.25 |
The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.
| scores on a scale | Placebo | Rotigotine |
|---|---|---|
| Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS) | -1.7 ± 4.3 | -1.9 ± 4.1 |
The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.
| scores on a scale | Placebo | Rotigotine |
|---|---|---|
| Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS) | -1.0 ± 3.2 | -1.8 ± 3.7 |
Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.
| scores on a scale | Placebo | Rotigotine |
|---|---|---|
| Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale) | -5.1 ± 11.7 | -8.3 ± 11.2 |
The classification of pain in Parkinson's disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4). A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement.
| scores on a scale | Placebo | Rotigotine |
|---|---|---|
| Musculoskeletal Pain | -1.4 ± 3.6 | -1.5 ± 4.2 |
| Chronic Pain | -3.1 ± 5.6 | -0.7 ± 2.9 |
| Fluctuation-Related Pain | -2.2 ± 4.6 | -4.2 ± 6.8 |
| Nocturnal Pain | -2.9 ± 6.1 | -2.4 ± 5.3 |
| Oro-Facial Pain | -0.4 ± 2.5 | -0.6 ± 2.3 |
| Discoloration; Edema/Swelling | -1.8 ± 4.9 | -1.7 ± 3.4 |
| Radicular Pain | -1.3 ± 3.8 | -1.1 ± 3.7 |
Collected over Treatment Emergent Adverse Events were reported from Baseline up to the Safety Follow-up Visit (approximately during 25 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/33 (3%) | 17/33 (51.5%) |
| Rotigotine | — | 2/35 (5.7%) | 20/35 (57.1%) |
| Event | Placebo | Rotigotine |
|---|---|---|
| Hip fractureInjury, poisoning and procedural complications | 1/33 | 0/35 |
| Oedema peripheralGeneral disorders | 0/33 | 1/35 |
| Cerebrovascular accidentNervous system disorders | 0/33 | 1/35 |
| Event | Placebo | Rotigotine |
|---|---|---|
| NauseaGastrointestinal disorders | 2/33 | 8/35 |
| HeadacheNervous system disorders | 4/33 | 6/35 |
| DizzinessNervous system disorders | 3/33 | 3/35 |
| Application site erythemaGeneral disorders | 0/33 | 3/35 |
| InsomniaPsychiatric disorders | 1/33 | 3/35 |
| DiarrhoeaGastrointestinal disorders | 2/33 | 0/35 |
| Upper respiratory tract infectionInfections and infestations | 2/33 | 1/35 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/33 | 1/35 |
| DyskinesiaNervous system disorders | 2/33 | 2/35 |
| HyperkinesiaNervous system disorders | 2/33 | 0/35 |
The Baseline Analysis Population refers to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.
| Age, Categorical(Participants) | Placebo | Rotigotine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 12 | 27 |
| >=65 years | 18 | 23 | 41 |
| Age, Continuous(years) | Placebo | Rotigotine | Total |
|---|---|---|---|
| Mean | 65.3 ± 13.8 | 66.5 ± 11.9 | 65.9 ± 12.8 |
| Sex: Female, Male(Participants) | Placebo | Rotigotine | Total |
|---|---|---|---|
| Female | 16 | 16 | 32 |
| Male | 17 | 19 | 36 |
| Race/Ethnicity, Customized(participants) | Placebo | Rotigotine | Total |
|---|---|---|---|
| American Indian / Alaskan native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Black | 0 | 0 | 0 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 |
| White | 32 | 35 | 67 |
| Other / mixed | 0 | 0 | 0 |
| Weight(kilograms) | Placebo | Rotigotine | Total |
|---|---|---|---|
| Mean | 80.15 ± 20.00 | 77.80 ± 13.71 | 78.94 ± 16.97 |
| Height(centimeters) | Placebo | Rotigotine | Total |
|---|---|---|---|
| Mean | 167.17 ± 9.92 | 168.63 ± 9.87 | 167.92 ± 9.85 |
| Body Mass Index (BMI)(kilogram per squaremeter) | Placebo | Rotigotine | Total |
|---|---|---|---|
| Mean | 28.54 ± 6.21 | 27.42 ± 4.74 | 27.96 ± 5.49 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UCB BIOSCIENCES GmbH