Trial Outcomes & Findings for Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome (NCT NCT01498120)

Last Updated: 2017-08-01

Results Overview

An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Visit 1 (Day 1) through End of Study (approximately 2 years)

Results posted on

2017-08-01

Participant Flow

This study started to enroll subjects in USA in January 2012 and concluded in December 2015.

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	14
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	5
Overall Study AE, non-serious non-fatal	3
Overall Study Other	4

Baseline Characteristics

Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotigotine n=14 Participants 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).
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.4 Years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Outcome measures

Outcome measures
Measure	Rotigotine (Safety Set) n=14 Participants The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. 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).
Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study	3 subjects

PRIMARY outcome

Timeframe: 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.

An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Outcome measures

Outcome measures
Measure	Rotigotine (Safety Set) n=14 Participants The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. 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).
Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study	10 subjects

Adverse Events

Rotigotine (Safety Set)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rotigotine (Safety Set) n=14 participants at risk The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. 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).
Cardiac disorders Palpitations	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Cardiac disorders Sinus tachycardia	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Gastrointestinal disorders Food poisoning	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Gastrointestinal disorders Nausea	28.6% 4/14 • Number of events 7 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Gastrointestinal disorders Vomiting	21.4% 3/14 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
General disorders Application site pruritus	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
General disorders Febrile disorders	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
General disorders Pyrexia	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
General disorders Oedema peripheral	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
General disorders Non-cardiac chest pain	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Infections and infestations Ear infection	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Infections and infestations Streptococcal infection	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Infections and infestations Upper respiratory tract infection	21.4% 3/14 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Infections and infestations Sinusitis	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Infections and infestations Urinary tract infection	14.3% 2/14 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Injury, poisoning and procedural complications Joint sprain	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Injury, poisoning and procedural complications Road traffic accident	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Injury, poisoning and procedural complications Sunburn	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Injury, poisoning and procedural complications Contusion	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Investigations Electrocardiogram QT corrected interval prolonged	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Investigations Blood sodium increased	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Investigations Toxicology laboratory analyses	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Investigations Drug screen positive	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Nervous system disorders Syncope	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Nervous system disorders Syncope vasovagal	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Nervous system disorders Headache	7.1% 1/14 • Number of events 3 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Nervous system disorders Presyncope	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Nervous system disorders Sudden onset of sleep	7.1% 1/14 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Renal and urinary disorders Enuresis	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Renal and urinary disorders Haematuria	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Reproductive system and breast disorders Dysmenorrhoea	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Skin and subcutaneous tissue disorders Dermal cyst	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Vascular disorders Orthostatic hypotension	7.1% 1/14 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months). All enrolled subjects who received at least 1 dose of study medication were included in the SS.

Additional Information

Clinical Trial Registries and Results Disclosure

UCB BIOSCIENCES GmbH

Phone: 40789+49 2173 48

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60