Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)

January 31, 2017 updated by: Impax Laboratories, LLC

A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)

The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

IPX159 was developed as an extended release formulation to reduce the fluctuation in nefopam concentration compared to IR and to reduce the incidence of peak or rate related side effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
159

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Brimingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network, Inc.
      • Oceanside, California, United States, 92056
        • The Research Center of Southern California
      • Redwood City, California, United States, 94063
        • Stanford Center for Human Sleep Research
      • Santa Monica, California, United States, 90404
        • Neurological Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Sleep-Alertness Disorder Center
    • Florida
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Ormond Beach, Florida, United States, 32174
        • Neurology Associates of Ormond Beach
      • Palm Harbor, Florida, United States, 34684
        • Resurgence Group
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research Inc
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences University
      • Macon, Georgia, United States, 31201
        • SleepMed of Central Georgia
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Community Research
      • Louisville, Kentucky, United States, 40217
        • Kentucky Research Group
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center Campus
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Sleep Health Centers, LLC
      • Brockton, Massachusetts, United States, 02301
        • Beacon Clinical Research, LLC
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes, LLC
    • New York
      • New York, New York, United States, 10168
        • Fieve Clinical Research, Inc.
      • Patchogue, New York, United States, 11772
        • Comprehensive Multiple Sclerosis Care Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, P.A.
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Community Research
    • Pennsylvania
      • Clarks Summit, Pennsylvania, United States, 18411
        • Sleep Lab of Northeastern Pennsylvania
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • SleepMed of SC
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennesee Health Science Center
    • Texas
      • Austin, Texas, United States, 78731
        • Future Research Trials of Neurology
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Lubbock, Texas, United States, 79410
        • Bhupesh Dihenia, M.D., P.A.
      • San Antonio, Texas, United States, 78205
        • Paragon Research Center, LLC
    • Washington
      • Seattle, Washington, United States, 98122
        • Sleep Medicine Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization
  2. Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening
  3. Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening
  4. BMI 18.5-32
  5. Negative alcohol and drug abuse screen
  6. Negative serum pregnancy test
  7. Agrees to use a medically acceptable method of contraception throughout the study and for 2 months after completing the study.
  8. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

Exclusion Criteria:

  1. Subjects who use or intend to use post screening the following medications or medication categories:

    • Sedative hypnotics, trazodone
    • Dopamine agonists, gabapentin, gabapentin enacarbil, pregabalin
    • Narcotic analgesics, other opioids, tramadol, cyclobenzaprine
    • Iron supplementation therapy
  2. History of HIV, hepatitis B or C
  3. Pregnant or breastfeeding.
  4. History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.
  5. History or presence of glaucoma
  6. Planning to take herbal medications (eg, hypericum perforatum [St John's Wort], licorice, ephedra, ginkgo, ginseng) during the study.
  7. Use of any investigational drug within the last 30 days or within a period of 5 times the drug's half-life, whichever is longer
  8. Subjects who, in the opinion of the Investigator, should not participate in the study or are not capable of following the study schedule for any reason
  9. Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IPX159
IPX159 90 mg daily at week 1 with titration to 180 mg daily at week 2 with possible titration to 270 mg daily at week 3.
Drug: IPX159
Placebo Comparator: Sugar Pill
IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale
Time Frame: Assessed at each study visit (visits 1-7), an expected average of 11 weeks
Assessed at each study visit (visits 1-7), an expected average of 11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Impax Laboratories, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Impax Study Director, Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPX159-B11-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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