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

• Sponsor: UCB BIOSCIENCES, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01498120
• Collaborator: (none)
• Enrollment: 14
• Locations: 5
• Arm: 1
• Duration (Months): 48
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Rotigotine	Phase 2

Detailed Description

Study design was changed and an amendment was prepared accordingly.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	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

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study [Visit 1 (Day 1) through End of Study (approximately 2 years)]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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	012	Los Angeles	California	United States
2	009	Orange	California	United States
3	014	Spring Hill	Florida	United States
4	013	Indianapolis	Indiana	United States
5	001	Destrehan	Louisiana	United States

Sponsors and Collaborators

• UCB BIOSCIENCES, Inc.

Investigators

• Study Director: UCB Clinical Trial Call Center, 1-877-822-9493 (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Product Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB BIOSCIENCES, Inc.
• ClinicalTrials.gov Identifier: NCT01498120
• Other Study ID Numbers: SP1005
• First Posted: Dec 23, 2011
• Last Update Posted: Aug 1, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by UCB BIOSCIENCES, Inc.: Rotigotine; Restless Legs Syndrome; RLS; Long-term; Adolescents
• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Rotigotine

Study Results

Participant Flow

Recruitment Details	This study started to enroll subjects in USA in January 2012 and concluded in December 2015.
Pre-assignment Detail	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.

Arm/Group Title	Rotigotine
Arm/Group Description	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).
Period Title: Overall Study
STARTED	14
COMPLETED	1
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Rotigotine
Arm/Group Description	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 Participants	14
Age (Count of Participants)
<=18 years	14 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	15.4 (1.2)
Sex: Female, Male (Count of Participants)
Female	10 71.4%
Male	4 28.6%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study
Description	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)

Outcome Measure Data

Analysis Population Description

All enrolled subjects who received at least 1 dose of study medication were included in the SS.

Arm/Group Title	Rotigotine (Safety Set)
Arm/Group Description	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).
Measure Participants	14
Number [subjects]	3

2. Primary Outcome

Title	Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study
Description	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)

Outcome Measure Data

Analysis Population Description

All enrolled subjects who received at least 1 dose of study medication were included in the SS.

Arm/Group Title	Rotigotine (Safety Set)
Arm/Group Description	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).
Measure Participants	14
Number [subjects]	10

Adverse Events

Time Frame	Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months).
Adverse Event Reporting Description	All enrolled subjects who received at least 1 dose of study medication were included in the SS.
Arm/Group Title	Rotigotine (Safety Set)
Arm/Group Description	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).
All Cause Mortality
	Rotigotine (Safety Set)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Rotigotine (Safety Set)
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Rotigotine (Safety Set)
	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)
Cardiac disorders
Palpitations	1/14 (7.1%)	1
Sinus tachycardia	1/14 (7.1%)	1
Gastrointestinal disorders
Food poisoning	1/14 (7.1%)	1
Nausea	4/14 (28.6%)	7
Vomiting	3/14 (21.4%)	6
General disorders
Application site pruritus	1/14 (7.1%)	1
Febrile disorders	1/14 (7.1%)	1
Pyrexia	1/14 (7.1%)	1
Oedema peripheral	1/14 (7.1%)	1
Non-cardiac chest pain	1/14 (7.1%)	1
Infections and infestations
Ear infection	1/14 (7.1%)	1
Streptococcal infection	1/14 (7.1%)	1
Upper respiratory tract infection	3/14 (21.4%)	3
Sinusitis	1/14 (7.1%)	1
Urinary tract infection	2/14 (14.3%)	2
Injury, poisoning and procedural complications
Joint sprain	1/14 (7.1%)	1
Road traffic accident	1/14 (7.1%)	1
Sunburn	1/14 (7.1%)	1
Contusion	1/14 (7.1%)	1
Investigations
Electrocardiogram QT corrected interval prolonged	1/14 (7.1%)	1
Blood sodium increased	1/14 (7.1%)	1
Toxicology laboratory analyses	1/14 (7.1%)	1
Drug screen positive	1/14 (7.1%)	1
Metabolism and nutrition disorders
Dehydration	1/14 (7.1%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/14 (7.1%)	1
Myalgia	1/14 (7.1%)	1
Nervous system disorders
Syncope	1/14 (7.1%)	1
Syncope vasovagal	1/14 (7.1%)	1
Headache	1/14 (7.1%)	3
Dizziness	1/14 (7.1%)	1
Presyncope	1/14 (7.1%)	1
Sudden onset of sleep	1/14 (7.1%)	2
Psychiatric disorders
Anxiety	1/14 (7.1%)	1
Renal and urinary disorders
Enuresis	1/14 (7.1%)	1
Haematuria	1/14 (7.1%)	1
Reproductive system and breast disorders
Dysmenorrhoea	1/14 (7.1%)	1
Skin and subcutaneous tissue disorders
Pruritus	1/14 (7.1%)	1
Dermal cyst	1/14 (7.1%)	1
Vascular disorders
Orthostatic hypotension	1/14 (7.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.