A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

UCB

Status and phase: Terminated; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: Rotigotine 2 mg/24 h; Drug: Rotigotine 3 mg/24 h; Drug: Rotigotine 1 mg/24 h

Study type: Interventional

Funder types: Industry

Identifiers

NCT03992196

RL0007

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).

Enrollment: 10 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject weighs >=40 kg
• Subject has completed at least one dose step in SP1006, a previous study of rotigotine in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria
• Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study drug
• Subject is expected to benefit from participation, in the opinion of the investigator

Exclusion criteria

• Subject is experiencing an ongoing serious Adverse Event (SAE) that is assessed to be related to rotigotine by the investigator or Sponsor
• Subject has active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at the final evaluation visit of the previous rotigotine study (ie, Visit 10 of SP1006)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Rotigotine

Experimental group

Description:

Subjects will be initiated on 1 mg/24 h rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine, with the aim of achieving the individually optimized dosage. Dose adjustment of rotigotine is allowed at any time during the following Maintenance Period up to a maximum dose of 3 mg/24 h. At the end of the Maintenance Period, subjects will be down-titrated.

Treatment:

Drug: Rotigotine 2 mg/24 h

Drug: Rotigotine 1 mg/24 h

Drug: Rotigotine 3 mg/24 h