Trial · NCT01976871
Switching From Oral Dopamine Agonists to Rotigotine
NCT01976871, Phase 4, Completed, John Winkelman, MD, PhD; results first posted 2016-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Switching From Oral Dopamine Agonists to Rotigotine. Trials, record NCT01976871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976871
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Switching From Oral Dopamine Agonists to Rotigotine
- NCT number
- NCT01976871
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 21 participants, actual
- Lead sponsor
- John Winkelman, MD, PhD
- Conditions
- Restless Legs Syndrome, Ekbom Syndrome, Willis-Ekbom Disease
- Interventions
- Rotigotine
- First posted
- 2013-11-06
- Last updated
- 2016-11-29
- Results first posted
- 2016-10-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Completing the Switch and Their Adverse Events | Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits | The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine. The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment. Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved. Adverse Events are reported in the Adverse Events module. |
| Secondary | International Restless Legs Scale (IRLS) | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | The IRLS will be used to determine the overall efficacy of RLS symptom control on rotigotine. The IRLS is a well-validated instrument for measuring RLS severity during the past week. It includes 10 questions encompassing intensity and frequency of symptoms, associated sleep problems, and the impact of symptoms on the patients' mood and daily functioning. This scale has been shown to have high internal consistency, inter-examiner reliability, test-retest reliability, and convergent validity. Minimum score 0, maximum score 40. A decrease in the IRLS score indicates a better outcome. |
| Secondary | RLS-6 Scale | Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | The RLS-6 scale will be used to determine the overall efficacy of RLS symptom control on rotigotine, calculated as a mean score for each scale during the final treatment week vs baseline. The RLS-6 scale are 11-point (0=not present to 10=very severe) metrics for measuring RLS severity. Four questions delineate a severity profile of RLS during different night and daytime periods: at bedtime, during the night, during the day at rest, during daily activities. The final two questions assess satisfaction with sleep and severity of sleepiness during the day. The RLS-6 scales have been validated on a day-to-day basis, with relatively low placebo effect compared to other RLS rating scales. Minimum score 0, maximum score 60. A decrease in the RLS-6 score indicates a better outcome. The RLS-6 scale was completed each day of the study and averaged for the baseline week (approximately days 1-7 of the study) and the final week (approximately days 21-28 of the maintenance period). |
| Secondary | Preference of Medication Scale (POM) | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | The POM will be used to assess patient satisfaction with treatment. The POM scale is designed to summarize subjects' preference for the study medication compared to prior therapy. It asks a single question: "How does this current medicine compare to the previous RLS medicine(s) you were taking?" The response set is as follows: (1) Much Better, I prefer this medication (indicating preference for rotigotine); (2) Slightly Better; (3) About the Same; (4) Slightly Worse; (5) Much Worse, I much prefer my previous medication (indicating preference for oral dopamine agonist). |
| Secondary | The Patient Global Impression of Change Scale | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | The Patient Global Impression of Change scale (PGIC) will be used to assess patient satisfaction with treatment. The PGIC assesses subjective changes in symptoms during clinical trials. This single-item scale asks participants to rate their symptoms as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The measure provides a responsive and easily interpretable assessment of participants' evaluations of the importance of their improvement or worsening. |
| Secondary | The Clinician Global Impression of Change Scale | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | The Clinician Global Impression of Change scale (CGIC) will be used to assess patient satisfaction with treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Completing the Switch and Their Adverse Events | Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits | participants | NUMBER | |
| SECONDARY | International Restless Legs Scale (IRLS) | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | units on a scale | MEAN | |
| SECONDARY | RLS-6 Scale | Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | units on a scale | MEAN | |
| SECONDARY | Preference of Medication Scale (POM) | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | participants | NUMBER | |
| SECONDARY | The Patient Global Impression of Change Scale | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | participants | NUMBER | |
| SECONDARY | The Clinician Global Impression of Change Scale | Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Completing the Switch and Their Adverse Events | Oral Dopamine Agonist to Rotigotine | Oral dopamine agonist to rotigotine switch success | 17 | participants | |
| Proportion of Patients Completing the Switch and Their Adverse Events | Oral Dopamine Agonist to Rotigotine | CGI-I responders (much or very much improved) | 14 | participants | |
| Proportion of Patients Completing the Switch and Their Adverse Events | Oral Dopamine Agonist to Rotigotine | Withdrew due to lack of efficacy | 3 | participants | |
| International Restless Legs Scale (IRLS) | Oral Dopamine Agonist to Rotigotine | Baseline (Day 1) IRLS score | 19.4 | Standard Deviation 5.5 | units on a scale |
| International Restless Legs Scale (IRLS) | Oral Dopamine Agonist to Rotigotine | Week 5 IRLS score | 12.7 | Standard Deviation 7.7 | units on a scale |
| RLS-6 Scale | Oral Dopamine Agonist to Rotigotine | Baseline RLS symptoms at bedtime | 3.9 | Standard Deviation 3.2 | units on a scale |
| RLS-6 Scale | Oral Dopamine Agonist to Rotigotine | Week 5 RLS symptoms at bedtime | 3.0 | Standard Deviation 3.1 | units on a scale |
| RLS-6 Scale | Oral Dopamine Agonist to Rotigotine | Baseline RLS symptoms during the night | 2.5 | Standard Deviation 2.3 | units on a scale |
| RLS-6 Scale | Oral Dopamine Agonist to Rotigotine | Week 5 RLS symptoms during the night | 2.1 | Standard Deviation 3.0 | units on a scale |
| RLS-6 Scale | Oral Dopamine Agonist to Rotigotine | Baseline RLS symptoms during the day at rest | 2.8 | Standard Deviation 2.5 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Dopamine Agonist to Rotigotine | 21 | |
| Overall Study | COMPLETED | Oral Dopamine Agonist to Rotigotine | 20 | |
| Overall Study | NOT COMPLETED | Oral Dopamine Agonist to Rotigotine | 1 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Oral Dopamine Agonist to Rotigotine | 9 | 20 | |
| other | Worsening of RLS symptoms during cross-titration | Nervous system disorders | Oral Dopamine Agonist to Rotigotine | 6 | 20 | |
| other | Skin reaction at patch application site | Skin and subcutaneous tissue disorders | Oral Dopamine Agonist to Rotigotine | 5 | 20 | |
| other | Insomnia | Nervous system disorders | Oral Dopamine Agonist to Rotigotine | 3 | 20 | |
| other | Nausea | Gastrointestinal disorders | Oral Dopamine Agonist to Rotigotine | 2 | 20 | |
| other | Headache | Nervous system disorders | Oral Dopamine Agonist to Rotigotine | 2 | 20 | |
| other | Fatigue | Nervous system disorders | Oral Dopamine Agonist to Rotigotine | 2 | 20 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Dopamine Agonist to Rotigotine | ||
| Total, other adverse events | Oral Dopamine Agonist to Rotigotine | 14 | 20 |
| Total, serious adverse events | Oral Dopamine Agonist to Rotigotine | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01976871
GET https://conductscience.org/api/trials/v1/NCT01976871/results?page=2