Restless Legs SyndromePhase 3NCT03728933
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
A Phase 3 study testing Rotigotine 1 milligram/24 hours and Rotigotine 2 milligram/24 hours in people with Restless Legs Syndrome, run by UCB Biopharma SRL at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Rotigotine 1 milligram/24 hours and Rotigotine 2 milligram/24 hours
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 25 Jul 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is male or female, and is >=13 and <18 years of age at Baseline
- Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood
- At Baseline, subject has a score of >=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS)
- At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill)
- Subjects who are receiving supplemental iron have been on a stable dose for at least 1 month prior to Screening
- 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 medication.
Who cannot join
- Subject has a serum ferritin level below the lower limit of normal at Visit 1/Screening
- Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening
- Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline
- Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study
- Subject is pregnant or nursing
- Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study
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- At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of >=20 mmHg in systolic blood pressure (SBP) or of >=10 mmHg in diastolic
- Subject has secondary Restless Legs Syndrome (RLS) (eg, due to renal insufficiency [uremia], iron deficiency, or rheumatoid arthritis)
- Subject has a lifetime history of suicide attempts (including actual attempt, interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
- Subject is taking a prohibited concomitant medication. Prohibited concomitant medication must have been discontinued at least 2 weeks prior to Screening (Visit 1)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS.
- Conditions
- Restless Legs Syndrome
- Being tested
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours, Placebo
- Keywords
- RLS, Rotigotine, Neupro
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine 1 milligram/24 hoursDrug
Also called Neupro
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm^2) patch size).
Rotigotine 2 milligram/24 hoursDrug
Also called Neupro
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm^2) patch size).
PlaceboDrug
Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable
| Study group | Role | What they receive |
|---|---|---|
| 2 milligram/24 hours rotigotine | Experimental | Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period. Receives: Drug: Rotigotine 1 milligram/24 hours; Drug: Rotigotine 2 milligram/24 hours |
| 3 milligram/24 hours rotigotine | Experimental | Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine (1 mg/24 h patch + 2 mg/24 patch at the same time), which is the assigned dose level throughout the 12-week Maintenance Period. Receives: Drug: Rotigotine 1 milligram/24 hours; Drug: Rotigotine 2 milligram/24 hours |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive matching placebo patches to maintain the blinding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score
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.
Measured: From Baseline to the end of the Maintenance Period (Day 106)
Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period
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.
Measured: From Baseline to the end of the Maintenance Period (Day 106)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: From Baseline to Safety Follow-Up (up to Week 20)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals
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.
Measured: From Baseline to Safety Follow-Up (up to Week 20)
Secondary outcomes (1)
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period
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.
Measured: From Baseline to the end of the Maintenance Period (Day 106)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start20 Dec 2018
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Why it stopped: Sponsor decision; Not a safety decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728933
- Sponsor's protocol ID
- SP1006
- Status last verified
- Sep 2023
- First submitted
- 31 Oct 2018
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this trial 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 individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT03728933
- Acronym / sponsor ID
- SP1006
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS, Rotigotine, Neupro
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision; Not a safety decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 milligram/24 hours rotigotine | Experimental | Drug: Rotigotine 1 milligram/24 hours, Drug: Rotigotine 2 milligram/24 hoursSubjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period. |
| 3 milligram/24 hours rotigotine | Experimental | Drug: Rotigotine 1 milligram/24 hours, Drug: Rotigotine 2 milligram/24 hoursSubjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine (1 mg/24 h patch + 2 mg/24 patch at the same time), which is the assigned dose level throughout the 12-week Maintenance Period. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will receive matching placebo patches to maintain the blinding. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject is male or female, and is >=13 and <18 years of age at Baseline
- Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood
- At Baseline, subject has a score of >=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS)
- At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill)
- Subjects who are receiving supplemental iron have been on a stable dose for at least 1 month prior to Screening
Key exclusion criteria (10 listed)
- Subject has a serum ferritin level below the lower limit of normal at Visit 1/Screening
- Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening
- Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline
- Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study
- Subject is pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotigotine 1 milligram/24 hoursAlso: NeuproPharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm^2) patch size). | Drug | 2 milligram/24 hours rotigotine, 3 milligram/24 hours rotigotine |
| Rotigotine 2 milligram/24 hoursAlso: NeuproPharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm^2) patch size). | Drug | 2 milligram/24 hours rotigotine, 3 milligram/24 hours rotigotine |
| PlaceboPharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable | Drug | Placebo |
Primary outcome
Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score
Time frame: 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.
Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period
Time frame: 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.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals
Time frame: 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.
1 secondary outcome
Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period
Time frame: From Baseline to the end of the Maintenance Period (Day 106)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data from this trial 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 individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotigotine 1 milligram/24 hours and Rotigotine 2 milligram/24 hours in people with Restless Legs Syndrome, run by UCB Biopharma SRL at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score (time frame: From Baseline to the end of the Maintenance Period (Day 106)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.