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Sponsor decision; Not a safety decision
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine 1 mg/24 h | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From Baseline until the Safety Follow-Up Visit (up to 14 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rl0007 101 | Culver City | California | 90230 | United States |
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.
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.
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.
10 participants were screened and considered enrolled, but only 9 participants were treated. The 10th participant was lost to follow-up prior dosing and no Adverse events were reported for this participant. Participant Flow refers to the Enrolled Set.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment | Participant signed the informed consent form but never received any study medication during the study. |
| FG001 | Rotigotine Final Dose 2 mg/24 h | Participants in this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. |
| FG002 | Rotigotine Final Dose 3 mg/24 h | Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
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| Treatment |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine Final Dose 2 mg/24 h | Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. | Posted | Number | percentage of participants | From Baseline until the Safety Follow-Up Visit (up to 14 Months) |
|
From Baseline until the Safety Follow-Up Visit (up to 14 Months)
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. AEs are presented for 9 treated participants in the Safety Set. 1 participant was enrolled, but did not report any AEs and is therefore not included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotigotine Final Dose 2 mg/24 h | Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2021 | Oct 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2023 | Oct 5, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Rotigotine 2 mg/24 h | Drug | 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). |
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| Rotigotine 3 mg/24 h | Drug | 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). |
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| 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. | 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. | Visit 9 (Month 12), compared to Baseline (in SP1006) |
| NOT COMPLETED |
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| BG001 | Rotigotine Final Dose 3 mg/24 h | Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Rotigotine Final Dose 3 mg/24 h | Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. |
|
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| Primary | 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. | The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. | Posted | Number | percentage of participants | From Baseline until the Safety Follow-Up Visit (up to 14 Months) |
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| Secondary | 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. | The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Visit 9 (Month 12), compared to Baseline (in SP1006) |
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|
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| Secondary | 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. | The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Visit 9 (Month 12), compared to Baseline (in SP1006) |
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| Secondary | 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. | The Safety Set consisted of all participants who had at least one patch (rotigotine) applied. Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Visit 9 (Month 12), compared to Baseline (in SP1006) |
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| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Rotigotine Final Dose 3 mg/24 h | Participants in this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine and the same dose was continued throughout the 1 year Maintenance Period. Dose adjustment was allowed at any time during the Maintenance Period, based on the investigator's assessment. At the end of the Maintenance Period, participants were down-titrated. | 0 | 7 | 0 | 7 | 6 | 7 |
| Application site erythema | General disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Application site rash | General disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| Severity: RLS symptoms during the night |
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| Severity: RLS symptoms during the day - at rest |
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| Severity: RLS symptoms during the day-not at rest |
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| How tired or sleepy during the day |
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