Trial · NCT03992196

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

NCT03992196, Phase 3, Terminated, UCB Biopharma SRL; results first posted 2023-10-30

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome. Trials, record NCT03992196. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03992196

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
NCT number: NCT03992196
Status: Terminated
Phases: Phase 3
Enrollment: 10 participants, actual
Lead sponsor: UCB Biopharma SRL
Conditions: Restless Legs Syndrome
Interventions: Rotigotine 1 mg/24 h, Rotigotine 2 mg/24 h, Rotigotine 3 mg/24 h
First posted: 2019-06-20
Last updated: 2023-10-30
Results first posted: 2023-10-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	From Baseline until the Safety Follow-Up Visit (up to 14 Months)	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, 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 Withdrawal of Study Medication	From Baseline until the Safety Follow-Up Visit (up to 14 Months)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that started during the Treatment Period or within 30 days following the end of the Treatment Period (ie, 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	Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9	Visit 9 (Month 12), compared to Baseline (in SP1006)	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.
Secondary	Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9	Visit 9 (Month 12), compared to Baseline (in SP1006)	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.
Secondary	Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9	Visit 9 (Month 12), compared to Baseline (in SP1006)	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 (not at rest). 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	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	From Baseline until the Safety Follow-Up Visit (up to 14 Months)	The Safety Set consisted of all participants who had at least one patch (rotigotine) applied.	percentage of participants	NUMBER
PRIMARY	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication	From Baseline until the Safety Follow-Up Visit (up to 14 Months)	The Safety Set consisted of all participants who had at least one patch (rotigotine) applied.	percentage of participants	NUMBER
SECONDARY	Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9	Visit 9 (Month 12), compared to Baseline (in SP1006)	The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.	score on a scale	MEAN
SECONDARY	Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9	Visit 9 (Month 12), compared to Baseline (in SP1006)	The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.	score on a scale	MEAN
SECONDARY	Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9	Visit 9 (Month 12), compared to Baseline (in SP1006)	The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	Rotigotine Final Dose 2 mg/24 h		100		percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	Rotigotine Final Dose 3 mg/24 h		85.7		percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication	Rotigotine Final Dose 2 mg/24 h		0		percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication	Rotigotine Final Dose 3 mg/24 h		0		percentage of participants
Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9	Rotigotine Final Dose 2 mg/24 h		NA	Standard Deviation NA	score on a scale
Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9	Rotigotine Final Dose 3 mg/24 h		NA	Standard Deviation NA	score on a scale
Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9	Rotigotine Final Dose 2 mg/24 h		NA	Standard Deviation NA	score on a scale
Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9	Rotigotine Final Dose 3 mg/24 h		NA	Standard Deviation NA	score on a scale
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9	Rotigotine Final Dose 2 mg/24 h	Satisfaction with sleep	NA	Standard Deviation NA	score on a scale
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9	Rotigotine Final Dose 3 mg/24 h	Satisfaction with sleep	NA	Standard Deviation NA	score on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Enrollment	STARTED	No Treatment	1
Enrollment	STARTED	Rotigotine Final Dose 2 mg/24 h	2
Enrollment	STARTED	Rotigotine Final Dose 3 mg/24 h	7
Enrollment	COMPLETED	No Treatment	0
Enrollment	COMPLETED	Rotigotine Final Dose 2 mg/24 h	2
Enrollment	COMPLETED	Rotigotine Final Dose 3 mg/24 h	7
Enrollment	NOT COMPLETED	No Treatment	1
Enrollment	NOT COMPLETED	Rotigotine Final Dose 2 mg/24 h	0
Enrollment	NOT COMPLETED	Rotigotine Final Dose 3 mg/24 h	0
Treatment	STARTED	No Treatment	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events40

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	Nausea	Gastrointestinal disorders	Rotigotine Final Dose 2 mg/24 h	0	2	0
other	Nausea	Gastrointestinal disorders	Rotigotine Final Dose 3 mg/24 h	3	7	5
other	Application site erythema	General disorders	Rotigotine Final Dose 2 mg/24 h	2	2	2
other	Application site erythema	General disorders	Rotigotine Final Dose 3 mg/24 h	2	7	2
other	Application site rash	General disorders	Rotigotine Final Dose 2 mg/24 h	0	2	0
other	Application site rash	General disorders	Rotigotine Final Dose 3 mg/24 h	1	7	1
other	Hypersensitivity	Immune system disorders	Rotigotine Final Dose 2 mg/24 h	0	2	0
other	Hypersensitivity	Immune system disorders	Rotigotine Final Dose 3 mg/24 h	1	7	1
other	Upper respiratory tract infection	Infections and infestations	Rotigotine Final Dose 2 mg/24 h	1	2	1
other	Upper respiratory tract infection	Infections and infestations	Rotigotine Final Dose 3 mg/24 h	1	7	1

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rotigotine Final Dose 2 mg/24 h	0	2
Total, all-cause mortality	Rotigotine Final Dose 3 mg/24 h	0	7
Total, other adverse events	Rotigotine Final Dose 2 mg/24 h	2	2
Total, other adverse events	Rotigotine Final Dose 3 mg/24 h	6	7
Total, serious adverse events	Rotigotine Final Dose 2 mg/24 h	0	2
Total, serious adverse events	Rotigotine Final Dose 3 mg/24 h	0	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rotigotine Final Dose 2 mg/24 h vs Rotigotine Final Dose 3 mg/24 h: deaths from any cause	Trial comparisons
Rotigotine Final Dose 2 mg/24 h vs Rotigotine Final Dose 3 mg/24 h: serious adverse events	Trial comparisons

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/NCT03992196

GET https://conductscience.org/api/trials/v1/NCT03992196/events?page=2

API reference For AI assistants