Trial · NCT03728933
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
NCT03728933, Phase 3, Terminated, UCB Biopharma SRL; results first posted 2023-10-26
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause. Trials, record NCT03728933. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03728933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
- NCT number
- NCT03728933
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Restless Legs Syndrome
- Interventions
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours, Placebo
- First posted
- 2018-11-02
- Last updated
- 2023-10-26
- Results first posted
- 2023-10-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score | From Baseline to the end of the Maintenance Period (Day 106) | The IRLS consisted of 10 questions, each scored using a 5-point scale ranging from 0=not present to 4=very severe. The IRLS sum score was calculated by summing up the single scores of all applicable questions, i.e., the total sum score ranged from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms). A score between 31 and 40, indicates very severe RLS. A score between 21 and 30 indicates severe RLS. A score between 11 and 20 indicates moderate RLS. A score between 1 and 10 indicates mild RLS and a score of 0 means no RLS. A negative change from Baseline indicates improvement. |
| Primary | Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period | From Baseline to the end of the Maintenance Period (Day 106) | The Clinical Global Impressions Item 1 (Severity of Illness) score ranges from 0 to 7 as follows: 0=not assessed, 1=normal, not ill at all, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill. The CGI Item 1 was completed during an interview between the participant and the investigator or designee. A negative change from Baseline indicates improvement. |
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline to Safety Follow-Up (up to Week 20) | TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. |
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals | From Baseline to Safety Follow-Up (up to Week 20) | TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (i.e., on or after the date of first patch application and within 30 days following the date of last patch removal + 1 day), or those events where the intensity worsened within this time frame. |
| Secondary | Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period | From Baseline to the end of the Maintenance Period (Day 106) | The RLS-6 Rating Scales was designed to assess the severity of RLS and consisted of 6 subscales. The subscales assessed severity of symptoms at the following times of the day/evening: falling asleep, during the night, during the day at rest, and during the day when engaged in daytime activities. In addition, the subscales assessed satisfaction with sleep and severity of daytime tiredness/sleepiness. Scores for each of the 6 subscales ranged from 0 (completely satisfied) to 10 (completely dissatisfied). The change from baseline was derived for each of the subscales and reported in this outcome measure. A negative change from Baseline indicates improvement. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score | From Baseline to the end of the Maintenance Period (Day 106) | The Full Analysis Set (FAS) consisted of all participants from the Safety Set who had a valid IRLS score and a valid clinical global impressions (CGI) Item 1 score at Baseline and a valid post-Baseline IRLS score and a valid post-Baseline CGI Item 1 score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period | From Baseline to the end of the Maintenance Period (Day 106) | The FAS consisted of all participants from the Safety Set who had a valid IRLS score and a valid CGI Item 1 score at Baseline and a valid post-Baseline IRLS score and a valid post-Baseline CGI Item 1 score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | score on a scale | MEAN |
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline to Safety Follow-Up (up to Week 20) | The Safety Set consisted of all participants from the Randomized Set (RS) who had at least one patch (rotigotine or placebo) applied. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals | From Baseline to Safety Follow-Up (up to Week 20) | The Safety Set consisted of all participants from the RS who had at least one patch (rotigotine or placebo) applied. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period | From Baseline to the end of the Maintenance Period (Day 106) | The FAS consisted of all participants from the Safety Set who had a valid IRLS score and a valid CGI Item 1 score at Baseline and a valid post-Baseline IRLS score and a valid post-Baseline CGI Item 1 score. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score | Placebo | -8.2 | Standard Deviation 6.8 | score on a scale | |
| Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score | Rotigotine 2 mg/24h | -14.0 | Standard Deviation 8.2 | score on a scale | |
| Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score | Rotigotine 3 mg/24h | -6.4 | Standard Deviation 5.8 | score on a scale | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period | Placebo | -1.0 | Standard Deviation 1.4 | score on a scale | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period | Rotigotine 2 mg/24h | -1.7 | Standard Deviation 1.1 | score on a scale | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period | Rotigotine 3 mg/24h | -0.8 | Standard Deviation 0.8 | score on a scale | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | 87.5 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Rotigotine 2 mg/24h | 87.5 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Rotigotine 3 mg/24h | 71.4 | percentage of participants | ||
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals | Placebo | 12.5 | percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | STARTED | Rotigotine 2 mg/24h | 8 | |
| Overall Study | STARTED | Rotigotine 3 mg/24h | 7 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | COMPLETED | Rotigotine 2 mg/24h | 7 | |
| Overall Study | COMPLETED | Rotigotine 3 mg/24h | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Rotigotine 2 mg/24h | 1 | |
| Overall Study | NOT COMPLETED | Rotigotine 3 mg/24h | 1 |
Source ClinicalTrials.gov
Adverse events111
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 | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 1 | 8 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Rotigotine 2 mg/24h | 0 | 8 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Rotigotine 3 mg/24h | 0 | 7 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 8 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Rotigotine 2 mg/24h | 0 | 8 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Rotigotine 3 mg/24h | 0 | 7 | 0 |
| other | Eye pain | Eye disorders | Placebo | 0 | 8 | 0 |
| other | Eye pain | Eye disorders | Rotigotine 2 mg/24h | 1 | 8 | 1 |
| other | Eye pain | Eye disorders | Rotigotine 3 mg/24h | 0 | 7 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 8 | 1 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, all-cause mortality | Rotigotine 2 mg/24h | 0 | 8 |
| Total, all-cause mortality | Rotigotine 3 mg/24h | 0 | 7 |
| Total, other adverse events | Placebo | 7 | 8 |
| Total, other adverse events | Rotigotine 2 mg/24h | 7 | 8 |
| Total, other adverse events | Rotigotine 3 mg/24h | 5 | 7 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Rotigotine 2 mg/24h | 0 | 8 |
| Total, serious adverse events | Rotigotine 3 mg/24h | 1 | 7 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03728933
GET https://conductscience.org/api/trials/v1/NCT03728933/results?page=2