Restless Legs Syndrome Clinical Trial
Official title:
An 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
Verified date | February 2016 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
Inclusion Criteria: - Tolerated the first dose level of Rotigotine in a previous study in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria - Is expected to benefit from participation, in the opinion of the investigator - Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and study patch application/removal, according to the judgment of the investigator Exclusion Criteria: - Previously participated in this study - Is experiencing an ongoing serious adverse event (SAE) that is assessed to be related to Rotigotine by the investigator or sponsor - Pregnant or nursing or is a female of childbearing potential who is not surgically sterile or does not consistently use 2 combined medically acceptable methods of birth control (including at least 1 barrier method), unless not sexually active - Any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate - Active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since the Last Visit" version of the Columbia Suicide Severity Rating Scale (C-SSRS) of the final evaluation visit of the previous Rotigotine study |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 001 | Destrehan | Louisiana |
United States | 013 | Indianapolis | Indiana |
United States | 012 | Los Angeles | California |
United States | 009 | Orange | California |
United States | 014 | Spring Hill | Florida |
Lead Sponsor | Collaborator |
---|---|
UCB BIOSCIENCES, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Withdrawal 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. | Visit 1 (Day 1) through End of Study (approximately 2 years) | Yes |
Primary | Occurrence of 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. | From Visit 1 (Day 1) through End of Study (approximately 2 years) | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04786314 -
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
|
N/A | |
Completed |
NCT01455012 -
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
|
Phase 4 | |
Terminated |
NCT01192503 -
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
|
Phase 2/Phase 3 | |
Completed |
NCT00721279 -
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
|
N/A | |
Completed |
NCT00530530 -
ASP8825 - Study in Patients With Restless Legs Syndrome
|
Phase 2 | |
Completed |
NCT00375284 -
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
|
Phase 4 | |
Completed |
NCT00942253 -
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
|
Phase 2 | |
Completed |
NCT00479531 -
Sequential Compression Devices for Treatment of Restless Legs Syndrome
|
Phase 3 | |
Recruiting |
NCT05581576 -
Pitolisant in Refractory Restless Legs Syndrome
|
Phase 4 | |
Active, not recruiting |
NCT03218969 -
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
|
Phase 1/Phase 2 | |
Recruiting |
NCT04144790 -
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
|
||
Completed |
NCT05787080 -
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
|
N/A | |
Not yet recruiting |
NCT05529095 -
Sublingual Apomorphine in Refractory Restless Legs Syndrome
|
Phase 4 | |
Recruiting |
NCT05044520 -
Clinical Features Associated With Restless Legs Syndrome.
|
||
Withdrawn |
NCT03849001 -
Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS
|
N/A | |
Completed |
NCT03076541 -
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
|
N/A | |
Recruiting |
NCT04145674 -
A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo
|
Phase 2 | |
Completed |
NCT02532608 -
Infra-slow Oscillations During Sleep
|
N/A | |
Completed |
NCT01528462 -
Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
|
||
Completed |
NCT00748098 -
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
|
Phase 3 |