A Phase 2 interventional study of Rotigotine in Restless Legs Syndrome, sponsored by UCB BIOSCIENCES, Inc.. Completed at 5 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by UCB BIOSCIENCES, Inc. · Phase 2, Interventional, and Treatment
This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.
Study design was changed and an amendment was prepared accordingly.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 14 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →UCB BIOSCIENCES, Inc. is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Optimal dose after titration period 0.5 mg/24 h (2.5 cm\^2)- 1 mg/24 h (5 cm\^2)- 2 mg/24 h (10 cm\^2)- 3 mg/24 h (15 cm\^2)
Drug: Rotigotine
Optimal dose after titration period 0.5 mg/24 h (2.5 cm\^2)- 1 mg/24 h (5 cm\^2)- 2 mg/24 h (10 cm\^2)- 3 mg/24 h (15 cm\^2) 1 patch /day
Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study
An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: Visit 1 (Day 1) through End of Study (approximately 2 years)
Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study
An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: From Visit 1 (Day 1) through End of Study (approximately 2 years)
This study started to enroll subjects in USA in January 2012 and concluded in December 2015.
| Milestone | Rotigotine |
|---|---|
| Started | 14 |
| Completed | 1 |
| Not completed | 13 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Ae, non-serious non-fatal | 3 |
| Withdrew: Other | 4 |
An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
| subjects | Rotigotine (Safety Set) |
|---|---|
| Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | 3 |
An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
| subjects | Rotigotine (Safety Set) |
|---|---|
| Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | 10 |
Collected over Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotigotine (Safety Set) | — | 0/14 (0%) | 10/14 (71.4%) |
| Event | Rotigotine (Safety Set) |
|---|---|
| NauseaGastrointestinal disorders | 4/14 |
| VomitingGastrointestinal disorders | 3/14 |
| Upper respiratory tract infectionInfections and infestations | 3/14 |
| Urinary tract infectionInfections and infestations | 2/14 |
| PalpitationsCardiac disorders | 1/14 |
| Sinus tachycardiaCardiac disorders | 1/14 |
| Food poisoningGastrointestinal disorders | 1/14 |
| Application site pruritusGeneral disorders | 1/14 |
| Febrile disordersGeneral disorders | 1/14 |
| PyrexiaGeneral disorders | 1/14 |
All enrolled subjects who received at least 1 dose of study medication were included in the SS.
| Age, Categorical(Participants) | Rotigotine |
|---|---|
| <=18 years | 14 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(Years) | Rotigotine |
|---|---|
| Mean | 15.4 ± 1.2 |
| Sex: Female, Male(Participants) | Rotigotine |
|---|---|
| Female | 10 |
| Male | 4 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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UCB BIOSCIENCES, Inc.