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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for 101468/253

Protocol Summary for 101468/253

Protocol Summary
Protocol Id: 101468/253
Secondary Ids:
  • SK&F101468/253
Title: An open label, single dose, dose rising, multi-centre study to assess the tolerability and pharmacokinetics of Ropinirole Immediate Release in adolescent patients with RLS.
Phase: phase 1
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 63172
IND/IDE Serial Number: 0061
Has Expanded Access?:
Study Type: Interventional
Oversight Authority:
  • France: Afssaps - French Health Products Safety Agency
  • United States: Food & Drug Administration
  • Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Collaborators:
Brief Summary: This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
Detailed Description:
Record Verification Date: May 2011
Status: Completed
Why Study Stopped:
Study Start Date: June 2005
Study Completion Date: December 2007
Study Completion Date Type: Actual
Primary Completion Date: December 2007
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Non-randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Pharmacokinetics/dynamics Study
Primary Outcomes:
  • AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy). yes
Secondary Outcomes:
  • PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.
Conditions:
  • Restless Legs Syndrome
Keywords:
  • RLS
  • PLMS
  • Adolescent
  • Periodic Limb Movements of Sleep
  • Ropinirole
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Year
Maximum Age: 17 Year
Enrollment: 20
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information