Restless Legs SyndromePhase 2NCT01521663
Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
A Phase 2 study testing IPX159 in people with Restless Legs Syndrome, run by Impax Laboratories, LLC at 38 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- IPX159
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 38 sitesUnited States
- Study dates
- Nov 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening
- Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening
- BMI 18.5-32
- Negative alcohol and drug abuse screen
- Negative serum pregnancy test
- Agrees to use a medically acceptable method of contraception throughout the study and for 2 months after completing the study.
- Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
Who cannot join
- 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
- History of HIV, hepatitis B or C
Show all 13Show fewer
- Pregnant or breastfeeding.
- History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.
- History or presence of glaucoma
- Planning to take herbal medications (eg, hypericum perforatum [St John's Wort], licorice, ephedra, ginkgo, ginseng) during the study.
- 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
- 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
- Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
NeuroTrials Research Inc
Atlanta, Georgia, 30342
Georgia Health Sciences University
Augusta, Georgia, 30912
Sleep-Alertness Disorder Center
Aurora, Colorado, 80012
Future Research Trials of Neurology
Austin, Texas, 78731
Johns Hopkins Bayview Medical Center Campus
Baltimore, Maryland, 21224
PAB Clinical Research
Brandon, Florida, 33511
Sleep Health Centers, LLC
Brighton, Massachusetts, 02135
University of Alabama at Birmingham
Brimingham, Alabama, 35294
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301
Community Research
Cincinnati, Ohio, 45255
Sleep Lab of Northeastern Pennsylvania
Clarks Summit, Pennsylvania, 18411
SleepMed of SC
Columbia, South Carolina, 29201
Community Research
Crestview Hills, Kentucky, 41017
QUEST Research Institute
Farmington Hills, Michigan, 48334
MD Clinical
Hallandale, Florida, 33009
Clinical Trial Network
Houston, Texas, 77074
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Scripps Clinic
La Jolla, California, 92037
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806
Kentucky Research Group
Louisville, Kentucky, 40217
Bhupesh Dihenia, M.D., P.A.
Lubbock, Texas, 79410
SleepMed of Central Georgia
Macon, Georgia, 31201
University of Tennesee Health Science Center
Memphis, Tennessee, 38163
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Fieve Clinical Research, Inc.
New York, New York, 10168
The Research Center of Southern California
Oceanside, California, 92056
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
Resurgence Group
Palm Harbor, Florida, 34684
Comprehensive Multiple Sclerosis Care Center
Patchogue, New York, 11772
Global Medical Institutes, LLC
Princeton, New Jersey, 08540
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Stanford Center for Human Sleep Research
Redwood City, California, 94063
Paragon Research Center, LLC
San Antonio, Texas, 78205
Neurological Research Institute
Santa Monica, California, 90404
Sleep Medicine Associates
Seattle, Washington, 98122
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
About this study
Official title: 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.
Read the 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- IPX159, Placebo
- Keywords
- Moderate to severe idiopathic RLS
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPX159Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| IPX159 | Experimental | 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. Receives: Drug: IPX159 |
| Sugar Pill | Placebo comparator | IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale
Measured: Assessed at each study visit (visits 1-7), an expected average of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impax Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Impax Study Director, Principal investigator, Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521663
- Sponsor's protocol ID
- IPX159-B11-02
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2012
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT01521663
- Acronym / sponsor ID
- IPX159-B11-02
- Conditions
- Restless Legs Syndrome
- Keywords
- Moderate to severe idiopathic RLS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPX159 | Experimental | Drug: IPX159IPX159 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. |
| Sugar Pill | Placebo comparator | Drug: PlaceboIPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening
- Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening
- BMI 18.5-32
- Negative alcohol and drug abuse screen
Key exclusion criteria (13 listed)
- Subjects who use or intend to use post screening the following medications or medication categories:
- History of HIV, hepatitis B or C
- Pregnant or breastfeeding.
- History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood.
- History or presence of glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPX159 | Drug | IPX159 |
| Placebo | Drug | Sugar Pill |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Impax Study Director principal investigator
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPX159 in people with Restless Legs Syndrome, run by Impax Laboratories, LLC at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.