Trial Outcomes & Findings for A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause (NCT NCT03728933)

Last Updated: 2023-10-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

From Baseline to the end of the Maintenance Period (Day 106)

Results posted on

2023-10-26

Participant Flow

The study started to enroll participants in December 2018 and concluded prematurely in July 2022.

The Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Placebo Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h Participants randomized to this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Study STARTED	8	8	7
Overall Study COMPLETED	5	7	6
Overall Study NOT COMPLETED	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h Participants randomized to this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Overall Study Withdrawal by Parent/Guardian	2	0	0
Overall Study Withdrawal by Subject	0	0	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Adverse Event	1	0	0

Baseline Characteristics

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=8 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=7 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Total n=23 Participants Total of all reporting groups
Age, Continuous	15.4 years STANDARD_DEVIATION 1.3 • n=5 Participants	16.1 years STANDARD_DEVIATION 1.1 • n=7 Participants	15.6 years STANDARD_DEVIATION 1.0 • n=5 Participants	15.7 years STANDARD_DEVIATION 1.1 • n=4 Participants
Age, Customized Adolescents (12-17 years)	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Other/Mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Baseline to the end of the Maintenance Period (Day 106)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=7 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=5 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score	-8.2 score on a scale Standard Deviation 6.8 • Interval 6.8 to	-14.0 score on a scale Standard Deviation 8.2 • Interval 8.2 to	-6.4 score on a scale Standard Deviation 5.8 • Interval 5.8 to

PRIMARY outcome

Timeframe: From Baseline to the end of the Maintenance Period (Day 106)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=7 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=5 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period	-1.0 score on a scale Standard Deviation 1.4 • Interval 1.4 to	-1.7 score on a scale Standard Deviation 1.1 • Interval 1.1 to	-0.8 score on a scale Standard Deviation 0.8 • Interval 0.8 to

PRIMARY outcome

Timeframe: From Baseline to Safety Follow-Up (up to Week 20)

Population: The Safety Set consisted of all participants from the Randomized Set (RS) who had at least one patch (rotigotine or placebo) applied.

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.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=8 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=7 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	87.5 percentage of participants	87.5 percentage of participants	71.4 percentage of participants

PRIMARY outcome

Timeframe: From Baseline to Safety Follow-Up (up to Week 20)

Population: The Safety Set consisted of all participants from the RS who had at least one patch (rotigotine or placebo) applied.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=8 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=7 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals	12.5 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=7 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=5 Participants Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period Satisfaction with sleep	-1.8 score on a scale Standard Deviation 4.1 • Interval 4.1 to	-4.7 score on a scale Standard Deviation 2.3 • Interval 2.3 to	-2.0 score on a scale Standard Deviation 2.8 • Interval 2.8 to
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period Severity: RLS symptoms at falling asleep	-2.8 score on a scale Standard Deviation 3.6 • Interval 3.6 to	-5.6 score on a scale Standard Deviation 1.6 • Interval 1.6 to	-2.8 score on a scale Standard Deviation 1.8 • Interval 1.8 to
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period Severity: RLS symptoms during the night	-1.0 score on a scale Standard Deviation 2.5 • Interval 2.5 to	-2.9 score on a scale Standard Deviation 3.0 • Interval 3.0 to	-2.4 score on a scale Standard Deviation 2.2 • Interval 2.2 to
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period Severity: RLS symptoms during the day - at rest	-1.4 score on a scale Standard Deviation 1.3 • Interval 1.3 to	-3.6 score on a scale Standard Deviation 3.5 • Interval 3.5 to	-2.4 score on a scale Standard Deviation 2.6 • Interval 2.6 to
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period Severity: RLS symptoms during the day-not at rest	-3.8 score on a scale Standard Deviation 1.9 • Interval 1.9 to	-4.3 score on a scale Standard Deviation 3.5 • Interval 3.5 to	-0.4 score on a scale Standard Deviation 1.1 • Interval 1.1 to
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period How tired or sleepy during the day	-3.0 score on a scale Standard Deviation 2.8 • Interval 2.8 to	-5.6 score on a scale Standard Deviation 2.1 • Interval 2.1 to	-3.0 score on a scale Standard Deviation 1.9 • Interval 1.9 to

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Rotigotine 2 mg/24h

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Rotigotine 3 mg/24h

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=8 participants at risk Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period.	Rotigotine 2 mg/24h n=8 participants at risk Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.	Rotigotine 3 mg/24h n=7 participants at risk Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/8 • From Baseline to Safety Follow-Up (up to Week 20) TEAEs were defined as events that started during Treatment Period or within 30 days following the end of 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 intensity worsened within this time frame. TEAEs were analyzed for Safety Set.	0.00% 0/8 • From Baseline to Safety Follow-Up (up to Week 20) TEAEs were defined as events that started during Treatment Period or within 30 days following the end of 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 intensity worsened within this time frame. TEAEs were analyzed for Safety Set.	14.3% 1/7 • Number of events 1 • From Baseline to Safety Follow-Up (up to Week 20) TEAEs were defined as events that started during Treatment Period or within 30 days following the end of 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 intensity worsened within this time frame. TEAEs were analyzed for Safety Set.

Other adverse events

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60