Restless Legs Syndrome
Conditions
Keywords
Rotigotine, Restless Legs Syndrome, RLS, Long-term, Adolescents
Brief summary
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.
Detailed description
Study design was changed and an amendment was prepared accordingly.
Interventions
DRUGRotigotine
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
Sponsors
UCB BIOSCIENCES, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | Visit 1 (Day 1) through End of Study (approximately 2 years) | An Adverse Event is any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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
This study started to enroll subjects in USA in January 2012 and concluded in December 2015.
Pre-assignment details
Participant Flow refers to the Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm\^2), 1mg/24h (5cm\^2), 2mg/24h (10cm\^2) and 3mg/24h (15cm\^2). | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | AE, non-serious non-fatal | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 4 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 15.4 Years STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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)
Population: All enrolled subjects who received at least 1 dose of study medication were included in the SS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine (Safety Set) | Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study | 10 subjects |
Primary
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)
Population: All enrolled subjects who received at least 1 dose of study medication were included in the SS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine (Safety Set) | Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study | 3 subjects |