Trial · NCT01498120
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
NCT01498120, Phase 2, Completed, UCB BIOSCIENCES, Inc.; results first posted 2016-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome. Trials, record NCT01498120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01498120
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
- NCT number
- NCT01498120
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Conditions
- Restless Legs Syndrome
- Interventions
- Rotigotine
- First posted
- 2011-12-23
- Last updated
- 2017-08-01
- Results first posted
- 2016-09-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | Visit 1 (Day 1) through End of Study (approximately 2 years) | An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
| Primary | Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | From Visit 1 (Day 1) through End of Study (approximately 2 years) | An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | Visit 1 (Day 1) through End of Study (approximately 2 years) | All enrolled subjects who received at least 1 dose of study medication were included in the SS. | subjects | NUMBER |
| PRIMARY | Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | From Visit 1 (Day 1) through End of Study (approximately 2 years) | All enrolled subjects who received at least 1 dose of study medication were included in the SS. | subjects | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | Rotigotine (Safety Set) | 3 | subjects | ||
| Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | Rotigotine (Safety Set) | 10 | subjects |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rotigotine | 14 | |
| Overall Study | COMPLETED | Rotigotine | 1 | |
| Overall Study | NOT COMPLETED | Rotigotine | 13 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Food poisoning | Gastrointestinal disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Nausea | Gastrointestinal disorders | Rotigotine (Safety Set) | 4 | 14 | 7 |
| other | Vomiting | Gastrointestinal disorders | Rotigotine (Safety Set) | 3 | 14 | 6 |
| other | Application site pruritus | General disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Febrile disorders | General disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Pyrexia | General disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Oedema peripheral | General disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
| other | Non-cardiac chest pain | General disorders | Rotigotine (Safety Set) | 1 | 14 | 1 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rotigotine (Safety Set) | ||
| Total, other adverse events | Rotigotine (Safety Set) | 10 | 14 |
| Total, serious adverse events | Rotigotine (Safety Set) | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01498120
GET https://conductscience.org/api/trials/v1/NCT01498120/events?page=2