Restless Legs SyndromePhase 3NCT03992196
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
A Phase 3 study testing Rotigotine 1 mg/24 h, Rotigotine 2 mg/24 h and Rotigotine 3 mg/24 h 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 assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (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 mg/24 h, Rotigotine 2 mg/24 h and Rotigotine 3 mg/24 h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 1 Sep 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 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Restless Legs Syndrome
- Being tested
- Rotigotine 1 mg/24 h, Rotigotine 2 mg/24 h, Rotigotine 3 mg/24 h
- Keywords
- RLS, Neupro, Rotigotine
- 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 mg/24 hDrug
Also called Neupro
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).
Rotigotine 2 mg/24 hDrug
Also called Neupro
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).
Rotigotine 3 mg/24 hDrug
Also called Neupro
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).
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Experimental | 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. Receives: Drug: Rotigotine 1 mg/24 h; Drug: Rotigotine 2 mg/24 h; Drug: Rotigotine 3 mg/24 h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: From Baseline until the Safety Follow-Up Visit (up to 14 Months)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication
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.
Measured: From Baseline until the Safety Follow-Up Visit (up to 14 Months)
Secondary outcomes (3)
Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9
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: Visit 9 (Month 12), compared to Baseline (in SP1006)
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 was completed during an interview between the participant and the investigator or designee. A negative change from Baseline indicates improvement.
Measured: Visit 9 (Month 12), compared to Baseline (in SP1006)
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
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.
Measured: Visit 9 (Month 12), compared to Baseline (in SP1006)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start3 Dec 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03992196
- Sponsor's protocol ID
- RL0007
- Status last verified
- Sep 2023
- First submitted
- 17 Jun 2019
- Last updated
- 30 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03992196
- Acronym / sponsor ID
- RL0007
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS, Neupro, Rotigotine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision; Not a safety decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 30 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 assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | Experimental | Drug: Rotigotine 1 mg/24 h, Drug: Rotigotine 2 mg/24 h, Drug: Rotigotine 3 mg/24 hSubjects 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
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 mg/24 hAlso: NeuproPharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 mg/24 h (5 cm^2 patch size). | Drug | Rotigotine |
| Rotigotine 2 mg/24 hAlso: NeuproPharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 mg/24 h (10 cm^2 patch size). | Drug | Rotigotine |
| Rotigotine 3 mg/24 hAlso: NeuproPharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 3 mg/24 h (15 cm^2 patch size). | Drug | Rotigotine |
Primary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9
Time frame: Visit 9 (Month 12), compared to Baseline (in SP1006)
Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9
Time frame: Visit 9 (Month 12), compared to Baseline (in SP1006)
Changes From Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9
Time frame: Visit 9 (Month 12), compared to Baseline (in SP1006)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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 mg/24 h, Rotigotine 2 mg/24 h and Rotigotine 3 mg/24 h 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 4 inclusion and 2 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 30 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. 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 30 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?
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From Baseline until the Safety Follow-Up Visit (up to 14 Months)). The study lists 2 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 30 Oct 2023.