Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00419692
First received: January 5, 2007
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.


Condition Intervention Phase
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Drug: Ropinirole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration [ Time Frame: dosing interval ]

Secondary Outcome Measures:
  • Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites [ Time Frame: Time taken for ropinirole concentration to fall to half initial value ]

Enrollment: 32
Study Start Date: August 2006
Intervention Details:
    Drug: Ropinirole
    Other Name: Ropinirole
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with a diagnosis of RLS
  • Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
  • Normal blood pressure pre-study
  • Light smokers only (<20/day)

Exclusion criteria:

  • History of postural hypotension or faints
  • Secondary RLS
  • Patients who suffer from a primary sleep disorder other than RLS
  • Patients diagnosed with movement disorders
  • Patients with unstable medical conditions
  • Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
  • Patients with abnormal laboratory values
  • Patients with hepatitis or HIV
  • Patients who abuse alcohol or drugs
  • Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419692

Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
South Africa
GSK Investigational Site
George, South Africa, 6530
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00419692     History of Changes
Other Study ID Numbers: ROR106470
Study First Received: January 5, 2007
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:
formulation,
controlled release for RLS,
pharmacokinetic,
RLS
food effect,
SK&F101468,

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014