Back to resultsA Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
Primary Purpose
Restless Legs Syndrome
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rotigotine 1 mg/24 h
Rotigotine 2 mg/24 h
Rotigotine 3 mg/24 h
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome focused on measuring RLS, Neupro, Rotigotine
Eligibility Criteria
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)
Sites / Locations
- Rl0007 101
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rotigotine
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of participants with treatment-emergent adverse events (TEAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Percentage of participants with TEAEs leading to permanent withdrawal of study medication
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs leading to withdrawal of study medication.
Secondary Outcome Measures
Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9
The sum score ranges from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms), which is the maximum score. 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.
Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9
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 is to be completed during an interview between the subject and the investigator or designee.
Changes from Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
The RLS-6 Rating Scales is designed to assess the severity of RLS and consists of 6 subscales. The subscales assess 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 assess satisfaction with sleep and severity of daytime tiredness/sleepiness. Scores for each of the 6 subscales range from 0 (completely satisfied) to 10 (completely dissatisfied).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03992196
Brief Title
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
Official Title
A Remote, Open-Label, Long-Term, Follow-up Study to Determine the Safety, Tolerability, and Efficacy of Rotigotine Transdermal System as Monotherapy in Adolescents With Restless Legs Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision; Not a safety decision
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
RLS, Neupro, Rotigotine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rotigotine 1 mg/24 h
Other Intervention Name(s)
Neupro
Intervention Description
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 mg/24 h (5 cm^2 patch size).
Intervention Type
Drug
Intervention Name(s)
Rotigotine 2 mg/24 h
Other Intervention Name(s)
Neupro
Intervention Description
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 mg/24 h (10 cm^2 patch size).
Intervention Type
Drug
Intervention Name(s)
Rotigotine 3 mg/24 h
Other Intervention Name(s)
Neupro
Intervention Description
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 3 mg/24 h (15 cm^2 patch size).
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs)
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame
From Baseline until the Safety Follow-Up Visit (up to 14 Months)
Title
Percentage of participants with TEAEs leading to permanent withdrawal of study medication
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAEs leading to withdrawal of study medication.
Time Frame
From Baseline until the Safety Follow-Up Visit (up to 14 Months)
Secondary Outcome Measure Information:
Title
Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9
Description
The sum score ranges from 0 (no RLS symptoms present) to 40 (maximum severity in all symptoms), which is the maximum score. 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.
Time Frame
From Baseline to Visit 9 (up to 13 Months)
Title
Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9
Description
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 is to be completed during an interview between the subject and the investigator or designee.
Time Frame
From Baseline to Visit 9 (up to 13 Months)
Title
Changes from Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Description
The RLS-6 Rating Scales is designed to assess the severity of RLS and consists of 6 subscales. The subscales assess 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 assess satisfaction with sleep and severity of daytime tiredness/sleepiness. Scores for each of the 6 subscales range from 0 (completely satisfied) to 10 (completely dissatisfied).
Time Frame
From Baseline to Visit 9 (up to 13 Months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Rl0007 101
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
IPD Sharing Time Frame
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://clinicalstudydatarequest.com
Learn more about this trial
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
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