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Trial record 1 of 1 for:    NCT03992196
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A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT03992196
Recruitment Status : Enrolling by invitation
First Posted : June 20, 2019
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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).

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Rotigotine 1 mg/24 h Drug: Rotigotine 2 mg/24 h Drug: Rotigotine 3 mg/24 h Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Rotigotine

Arm Intervention/treatment
Experimental: Rotigotine
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
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).
Other Name: Neupro

Drug: Rotigotine 2 mg/24 h
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).
Other Name: Neupro

Drug: Rotigotine 3 mg/24 h
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).
Other Name: Neupro




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From Study Entry until the Safety Follow-Up Visit (up to 14 Months) ]
    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.

  2. Withdrawals due to Adverse Events (AEs) [ Time Frame: From Study Entry until the Safety Follow-Up Visit (up to 14 Months) ]
    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. AEs leading to withdrawal of study medication.


Secondary Outcome Measures :
  1. Changes from Baseline in International Restless Legs Rating Scale (IRLS) sum score at Visit 9 [ Time Frame: From Baseline to Visit 9 (up to 13 Months) ]
    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.

  2. Changes from Baseline in Clinical Global Impressions (CGI) Item 1 at Visit 9 [ Time Frame: From Baseline to Visit 9 (up to 13 Months) ]
    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.

  3. Changes from Baseline in Restless Legs-6 Rating Scales (RLS-6) at Visit 9 [ Time Frame: From Baseline to Visit 9 (up to 13 Months) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992196


Locations
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United States, California
Rl0007 101
Los Angeles, California, United States, 90094
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03992196    
Other Study ID Numbers: RL0007
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: http://clinicalstudydatarequest.com

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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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
RLS
Neupro
Rotigotine
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs