Restless Legs SyndromePhase 2NCT00834327
Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome
A Phase 2 study of Restless Legs Syndrome, run by Neurogen Corporation at 24 sites in United States.
Trial summary
This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5 treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR tablets and 1 placebo arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 24 sitesUnited States
- Study dates
- Feb 2009to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-85 years;
- Must have a score of ≥20 on the IRLS at Day 1 (Baseline) Visit;
- Have a history of moderate to severe RLS symptoms that disrupted sleep for at least 3 nights per week over at least a 3 month period either immediately before screening or prior to starting any RLS treatment;
- Patients must be off dopamine agonists or any other medications they are taking for RLS for a minimum of one week or 5 half lives of the RLS medication whichever is longer, prior to the Day 1 (Baseline) Visit;
- Patients must be in good general health as determined by a thorough medical history and physical examination (including vital signs), and 12-lead electrocardiogram (ECG);
- Patients must have clinical laboratory values within normal reference range or must not be clinically significantly abnormal as judged by the Investigator at screening;
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- Females of childbearing potential must be using an acceptable method of contraception, have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline. Acceptable methods of contraception include oral, intrauterine, implantable, injectable contraceptives, hormonal patch, double barrier methods or condoms impregnated with spermicide. After screening, patients using oral contraceptive methods of contraception must agree to add an additional method until 30 days following the last dose of study medication. Women on oral contraceptives must have been using them for at least one month prior to screening;
- Male patients with partners of childbearing potential must agree to use adequate contraception (use of a condom and a spermicidal) during the study and for 3 months after the study;
- Female patients who have been surgically sterilized are eligible if they have a negative pregnancy test at screening and at Baseline;
- If receiving hormone replacement therapy, patients must be on a stable regimen for minimum of 3 months prior to screening;
- Patients must be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures.
Who cannot join
- Clinically significant unstable medical illness;
- Clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;
- History of non-basal cell cancer or squamous cell cancers or carcinoma in situ of the cervix within 2 years before the screening visit are excluded; for all other cancer diagnoses, patients with a history within 5 years before the screening visit are excluded;
- Patients with plasma ferritin levels less than 10 ng/mL at screening;
- A supine blood pressure > 140/90 mm/Hg at screening or baseline;
- Patients taking OTC or prescription medications that can, in the judgment of the investigator, exacerbate or are the cause of their RLS symptoms will be excluded from the study;
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- Patients taking prescription drug therapy or over the counter (OTC) medication for chronic medical conditions other then RLS who are not on stable doses for at least two months prior to screening; patients who are not off any investigational drug for at least 30 days prior to screening;
- History of chronic use of dopamine antagonists for more than 6 months within the past 2 years;
- History or presence of chronic pain other than that associated with RLS. Patients should be excluded if the preponderance of the patient's complaints is related to pain and not associated with the urge to move;
- Clinically significant narcolepsy, parasomnia as an adult, significant circadian rhythm disorder, or secondary causes of RLS, (e.g., uremia or neuropathy);
- Any condition that may affect oral drug absorption;
- Travel across more than three time zones, have an expected change in sleep schedules of 6 hours or more, or have involvement in night shift work within seven days prior to screening through to study completion;
- Any clinically significant abnormal finding at the Screening Visit on physical examination, vital signs, or ECG, as determined by the Investigator; (The QTcF interval must be ≤ 450 msec for males and ≤ 470 msec for females);
- History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to aplindore or structurally similar compounds such as flesinomax, ropinirole or ziprasadone;
- Pregnant or lactating females;
- Recent history (≤ one year) of alcohol or drug abuse, or current evidence of substance dependence or abuse as defined by DSM-IV criteria;
- Regular consumption of large amounts of xanthine-containing substances (i.e. more than 10 cups of coffee or equivalent amounts of xanthine-containing substances per day);
- Prior exposure to aplindore;
- Patients deemed to be in the high risk category for sleep apnea as determined by the Modified Berlin Questionnaire;
- Patients who failed prior treatment with dopamine agonists as evidenced by lack of efficacy at the maximum tolerated dose;
- Patients who test positive at Screening for hepatitis B surface antigen or hepatitis C antiboby or has a history of a positive result
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Neurotrials Research, Inc.
Atlanta, Georgia, 30342
Quest Research Institute
Bingham Farms, Michigan, 48025
Sleep Medicine and Research Center - St Luke's Hospital
Chesterfield, Missouri, 63017
Comunity Reasearch
Cincinnati, Ohio, 45227
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45246
Tampa Bay Medical Research
Clearwater, Florida, 33761
Community Research & Sleep Management Institute
Crestview Hills, Kentucky, 41017
Sleep Medicine Associates of Texas, P.A.
Dallas, Texas, 75231
University Clinical Research Deland, LLC
DeLand, Florida, 32720
MD Clinical
Hallandale, Florida, 33009
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Excell Research, Inc.
Oceanside, California, 92056
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
University Clinical Research
Pembroke Pines, Florida, 33024
Broward Research Group
Pembroke Pines, Florida, 33026
HOPE Research Institute
Phoenix, Arizona, 85050
Lynn Institute of Pueblo
Pueblo, Colorado, 81001
Wake Research Associates
Raleigh, North Carolina, 27612
Paragon Research Center
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33013
Genova Clinical Research
Tuscon, Arizona, 85741
Sleep & Behavior Medicine Institute
Vernon Hills, Illinois, 60061
Gaylord Sleep Medicine
Wallingford, Connecticut, 06492
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Four Week Study of the Efficacy and Safety of Four Doses (0.05 mg, 0.1 mg, 0.25 mg, 0.5 mg) of Aplindore MR Tablets vs. Placebo in Idiopathic Restless Legs Syndrome.
This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5 treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and neither patients, nor the investigators, will know what treatment the patient is receiving. Patients will be assigned a dose and will be maintained at that dose for several weeks (2 treatment arms include a short titration period). The entire study will take about 6 weeks. The study will measure how effective aplindore is in decreasing symptoms of Restless Legs Syndrome, and will also assess the safety and tolerability of aplindore.
Read the detailed description
Two hundred and thirty patients will be randomly assigned to one of five treatment arms in this outpatient study. Of the four aplindore arms, two arms will be titrated over a brief period until the targeted dose is achieved, and then as with the other arms, will be maintained for several weeks. Dosing will take place over a total of about 4 weeks.
- Conditions
- Restless Legs Syndrome
- Being tested
- aplindore MR tablets or Placebo
- Keywords
- Restless Legs Syndrome
- 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.
aplindore MR tablets or PlaceboDrug
aplindore MR tablets administered QD for about 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | aplindore 0.05 mg MR total daily dose Receives: Drug: aplindore MR tablets or Placebo |
| 2 | Experimental | aplindore 0.1 mg MR total daily dose Receives: Drug: aplindore MR tablets or Placebo |
| 3 | Experimental | aplindore 0.25 mg MR total daily dose (to include short titration) Receives: Drug: aplindore MR tablets or Placebo |
| 4 | Experimental | aplindore 0.5 mg MR total daily dose (to include short titration) Receives: Drug: aplindore MR tablets or Placebo |
| 5 | Placebo comparator | Placebo Receives: Drug: aplindore MR tablets or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS).
Measured: Day 1, Day 14, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Neurogen acquired by Ligand Pharmaceuticals - no further support for the study. No safety concerns identified.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834327
- Sponsor's protocol ID
- Aplindore-250
- Status last verified
- Oct 2009
- First submitted
- 30 Jan 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Four Week Study of the Efficacy and Safety of Four Doses (0.05 mg, 0.1 mg, 0.25 mg, 0.5 mg) of Aplindore MR Tablets vs. Placebo in Idiopathic Restless Legs Syndrome.
- ClinicalTrials.gov ID
- NCT00834327
- Acronym / sponsor ID
- Aplindore-250
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Neurogen acquired by Ligand Pharmaceuticals - no further support for the study. No safety concerns identified.
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Neurogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 3 Feb 2009 (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.
This is a clinical trial to be conducted at multiple sites in the USA. Patients diagnosed with moderate to severe Restless Legs Syndrome will be randomly allocated to one of 5 treatment arms in the study. The 5 arms include 4 arms with different doses of aplindore MR tablets and 1 placebo arm. The treatment will be taken once a day. The study is blinded and neither patients, nor the investigators, will know what treatment the patient is receiving. Patients will be assigned a dose and will be maintained at that dose for several weeks (2 treatment arms include a short titration period). The entire study will take about 6 weeks. The study will measure how effective aplindore is in decreasing symptoms of Restless Legs Syndrome, and will also assess the safety and tolerability of aplindore.
Detailed description
Two hundred and thirty patients will be randomly assigned to one of five treatment arms in this outpatient study. Of the four aplindore arms, two arms will be titrated over a brief period until the targeted dose is achieved, and then as with the other arms, will be maintained for several weeks. Dosing will take place over a total of about 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aplindore MR tablets or Placeboaplindore 0.05 mg MR total daily dose |
| 2 | Experimental | Drug: aplindore MR tablets or Placeboaplindore 0.1 mg MR total daily dose |
| 3 | Experimental | Drug: aplindore MR tablets or Placeboaplindore 0.25 mg MR total daily dose (to include short titration) |
| 4 | Experimental | Drug: aplindore MR tablets or Placeboaplindore 0.5 mg MR total daily dose (to include short titration) |
| 5 | Placebo comparator | Drug: aplindore MR tablets or PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female 18-85 years;
- Must have a score of ≥20 on the IRLS at Day 1 (Baseline) Visit;
- Have a history of moderate to severe RLS symptoms that disrupted sleep for at least 3 nights per week over at least a 3 month period either immediately before screening or prior to starting any RLS treatment;
- Patients must be off dopamine agonists or any other medications they are taking for RLS for a minimum of one week or 5 half lives of the RLS medication whichever is longer, prior to the Day 1 (Baseline) Visit;
- Patients must be in good general health as determined by a thorough medical history and physical examination (including vital signs), and 12-lead electrocardiogram (ECG);
Key exclusion criteria (21 listed)
- Clinically significant unstable medical illness;
- Clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;
- History of non-basal cell cancer or squamous cell cancers or carcinoma in situ of the cervix within 2 years before the screening visit are excluded; for all other cancer diagnoses, patients with a history within 5 years before the screening visit are excluded;
- Patients with plasma ferritin levels less than 10 ng/mL at screening;
- A supine blood pressure > 140/90 mm/Hg at screening or baseline;
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 |
|---|---|---|
| aplindore MR tablets or Placeboaplindore MR tablets administered QD for about 4 weeks | Drug | 1, 2, 3, 4, 5 |
Primary outcome
The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS).
Time frame: Day 1, Day 14, and Day 28
Results and safety
The study was stopped early (reason given: Neurogen acquired by Ligand Pharmaceuticals - no further support for the study. No safety concerns identified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Restless Legs Syndrome, run by Neurogen Corporation at 24 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 11 inclusion and 21 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: stopped early, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 was stopped early (reason given: Neurogen acquired by Ligand Pharmaceuticals - no further support for the study. No safety concerns identified.). Results are not available in the source record.
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?
The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS). (time frame: Day 1, Day 14, and Day 28). 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 14 Oct 2009.