Trial record 1 of 1 for:
sp1006
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03728933 |
Recruitment Status :
Terminated
(Sponsor decision; Not a safety decision)
First Posted : November 2, 2018
Results First Posted : October 26, 2023
Last Update Posted : October 26, 2023
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Sponsor:
UCB Biopharma SRL
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Restless Legs Syndrome |
Interventions |
Drug: Rotigotine 1 milligram/24 hours Drug: Rotigotine 2 milligram/24 hours Drug: Placebo |
Enrollment | 23 |
Participant Flow
Recruitment Details | The study started to enroll participants in December 2018 and concluded prematurely in July 2022. |
Pre-assignment Details | The Participant Flow refers to the Randomized Set. |
Arm/Group Title | Placebo | Rotigotine 2 mg/24h | Rotigotine 3 mg/24h |
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Arm/Group Description | Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period. | Participants randomized to this arm were initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. | Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. |
Period Title: Overall Study | |||
Started | 8 | 8 | 7 |
Completed | 5 | 7 | 6 |
Not Completed | 3 | 1 | 1 |
Reason Not Completed | |||
Withdrawal by Parent/Guardian | 2 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 1 |
Lost to Follow-up | 0 | 1 | 0 |
Adverse Event | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | Rotigotine 2 mg/24h | Rotigotine 3 mg/24h | Total | |
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Arm/Group Description | Participants randomized to this arm received placebo as a comparator matched to rotigotine during 3 week titration period and is continued throughout the 12-week Maintenance Period. | Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. | Participants randomized to this arm were initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine during 3 week titration period and the same dose is continued throughout the 12-week Maintenance Period. | Total of all reporting groups | |
Overall Number of Baseline Participants | 8 | 8 | 7 | 23 | |
Baseline Analysis Population Description |
The Randomized Set consisted of all participants from the Enrolled Set who have been randomized.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 8 participants | 8 participants | 7 participants | 23 participants | |
15.4 (1.3) | 16.1 (1.1) | 15.6 (1.0) | 15.7 (1.1) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 7 participants | 23 participants | |
Adolescents (12-17 years) |
8 100.0%
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8 100.0%
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7 100.0%
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23 100.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 7 participants | 23 participants | |
Female |
6 75.0%
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6 75.0%
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2 28.6%
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14 60.9%
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Male |
2 25.0%
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2 25.0%
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5 71.4%
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9 39.1%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 7 participants | 23 participants | |
American Indian/Alaskan Native |
0 0.0%
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1 12.5%
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0 0.0%
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1 4.3%
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Black |
0 0.0%
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0 0.0%
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1 14.3%
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1 4.3%
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White |
7 87.5%
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7 87.5%
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6 85.7%
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20 87.0%
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Other/Mixed |
1 12.5%
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0 0.0%
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0 0.0%
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1 4.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 8 participants | 7 participants | 23 participants | |
Not Hispanic or Latino |
8 100.0%
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8 100.0%
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7 100.0%
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23 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | 001 844 599 2273 |
EMail: | UCBCares@ucb.com |
Responsible Party: | UCB Pharma ( UCB Biopharma SRL ) |
ClinicalTrials.gov Identifier: | NCT03728933 |
Other Study ID Numbers: |
SP1006 |
First Submitted: | October 31, 2018 |
First Posted: | November 2, 2018 |
Results First Submitted: | October 5, 2023 |
Results First Posted: | October 26, 2023 |
Last Update Posted: | October 26, 2023 |