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

Phase 3

Terminated

Conditions: Restless Legs Syndrome

Interventions: Drug: Rotigotine 1 mg/24 h
Drug: Rotigotine 2 mg/24 h
Drug: Rotigotine 3 mg/24 h

Registration Number: NCT03992196

Lead Sponsor: UCB Biopharma SRL

Brief Summary: The purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Subject weighs >=40 kg
Subject has completed at least one dose step in SP1006, a previous study of rotigotine in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study drug
Subject is expected to benefit from participation, in the opinion of the investigator

Exclusion Criteria

Subject is experiencing an ongoing serious Adverse Event (SAE) that is assessed to be related to rotigotine by the investigator or Sponsor
Subject has active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at the final evaluation visit of the previous rotigotine study (ie, Visit 10 of SP1006)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotigotine	Rotigotine 1 mg/24 h	Subjects will be initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, with the aim of achieving the individually optimized dosage. Dose adjustment of rotigotine is allowed at any time during the following Maintenance Period up to a maximum dose of 3 mg/24 h. At the end of the Maintenance Period, subjects will be down-titrated.
Rotigotine	Rotigotine 3 mg/24 h	Subjects will be initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, with the aim of achieving the individually optimized dosage. Dose adjustment of rotigotine is allowed at any time during the following Maintenance Period up to a maximum dose of 3 mg/24 h. At the end of the Maintenance Period, subjects will be down-titrated.
Rotigotine	Rotigotine 2 mg/24 h	Subjects will be initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, with the aim of achieving the individually optimized dosage. Dose adjustment of rotigotine is allowed at any time during the following Maintenance Period up to a maximum dose of 3 mg/24 h. At the end of the Maintenance Period, subjects will be down-titrated.

Primary Outcome Measures

Name	Time	Method
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.
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 Outcome Measures

Name	Time	Method
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.
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.
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.