Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00895232
First received: May 7, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of three treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.


Condition Intervention Phase
Restless Legs Syndrome
Drug: iron sucrose injection (Venofer)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Enrollment: 21
Study Start Date: November 2003
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort I
500 mg x 1 dose Venofer
Drug: iron sucrose injection (Venofer)
Active Comparator: Cohort II
500 mg x 2 doses Venofer
Drug: iron sucrose injection (Venofer)
Active Comparator: Cohort III
500 mg x 2 doses Venofer
Drug: iron sucrose injection (Venofer)

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • RLS signs and symptoms affirming diagnosis
  • A baseline score >= 18 was required on the International RLS Study Group (IRLSSG) Rating Scale
  • At least one leg was required ot have an average baseline Periodic Leg Movement (PLM) while asleep >= 15 movements per hour by actigraphy
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Marc Tokars, Senior Director of Clinical Operations, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00895232     History of Changes
Other Study ID Numbers: 1VEN03032
Study First Received: May 7, 2009
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014