A Phase 3 interventional study of Rotigotine 1 mg/24 h and Rotigotine 2 mg/24 h in Restless Legs Syndrome, sponsored by UCB Biopharma SRL. Terminated at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by UCB Biopharma SRL · Phase 3, Interventional, and Treatment
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).
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
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Exclusion Criteria:
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.
Drug: Rotigotine 1 mg/24 h · Drug: Rotigotine 2 mg/24 h · Drug: Rotigotine 3 mg/24 h
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).
Also known as: 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).
Also known as: 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).
Also known as: Neupro
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.
Time frame: 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.
Time frame: From Baseline until the Safety Follow-Up Visit (up to 14 Months)
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.
Time frame: 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.
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
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.
Time frame: Visit 9 (Month 12), compared to Baseline (in SP1006)
The study started to enroll participants in December 2019 and concluded prematurely in September 2022. Study participants entered this study from the parent rotigotine study in adolescents (SP1006) (NCT03728933).
| Milestone | No Treatment | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|---|
| Started | 1 | 2 | 7 |
| Completed | 0 | 2 | 7 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Lost to follow-up prior dosing | 1 | 0 | 0 |
| Milestone | No Treatment | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|---|
| Started | 0 | 2 | 7 |
| Completed | 0 | 2 | 1 |
| Not completed | 0 | 0 | 6 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Poor drug compliance withdrawn by team and sponsor | 0 | 0 | 1 |
| Withdrew: Withdrawal due to non-compliance | 0 | 0 | 1 |
| Withdrew: Pi's decision due to investigational medicinal product non-compliance | 0 | 0 | 1 |
| Withdrew: Withdrawal by parent/guardian | 0 | 0 | 2 |
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 | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 100 | 85.7 |
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.
| percentage of participants | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Study Medication | 0 | 0 |
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.
| score on a scale | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|
| Changes From Baseline in International Restless Legs Rating Scale (IRLS) Sum Score at Visit 9 | NA ± NA | NA ± NA |
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.
| score on a scale | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|
| Changes From Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9 | NA ± NA | NA ± NA |
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.
| score on a scale | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|
| Satisfaction with sleep | NA ± NA | NA ± NA |
| Severity: RLS symptoms at falling asleep | NA ± NA | NA ± NA |
| Severity: RLS symptoms during the night | NA ± NA | NA ± NA |
| Severity: RLS symptoms during the day - at rest | NA ± NA | NA ± NA |
| Severity: RLS symptoms during the day-not at rest | NA ± NA | NA ± NA |
| How tired or sleepy during the day | NA ± NA | NA ± NA |
Collected over From Baseline until the Safety Follow-Up Visit (up to 14 Months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotigotine Final Dose 2 mg/24 h | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Rotigotine Final Dose 3 mg/24 h | 0/7 (0%) | 0/7 (0%) | 6/7 (85.7%) |
| Event | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h |
|---|---|---|
| Application site erythemaGeneral disorders | 2/2 | 2/7 |
| Upper respiratory tract infectionInfections and infestations | 1/2 | 1/7 |
| Suspected COVID-19Infections and infestations | 1/2 | 0/7 |
| Procedural dizzinessInjury, poisoning and procedural complications | 1/2 | 0/7 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 1/2 | 0/7 |
| PruritusSkin and subcutaneous tissue disorders | 1/2 | 1/7 |
| NauseaGastrointestinal disorders | 0/2 | 3/7 |
| Application site rashGeneral disorders | 0/2 | 1/7 |
| HypersensitivityImmune system disorders | 0/2 | 1/7 |
| COVID-19Infections and infestations | 0/2 | 1/7 |
The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Due to data protection/data privacy, data cannot be reported for a single participant.
| Age, Customized(Participants) | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h | Total |
|---|---|---|---|
| Adolescents (12-17 years) | 2 | 7 | 9 |
| Sex: Female, Male(Participants) | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 0 | 5 | 5 |
| Race/Ethnicity, Customized(Participants) | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h | Total |
|---|---|---|---|
| Black or African American | 0 | 1 | 1 |
| White | 2 | 6 | 8 |
| Race/Ethnicity, Customized(Participants) | Rotigotine Final Dose 2 mg/24 h | Rotigotine Final Dose 3 mg/24 h | Total |
|---|---|---|---|
| Not Hispanic or Latino | 2 | 7 | 9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
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UCB Biopharma SRL