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Epilepsy With Simple or Complex Partial Onset SeizuresPhase 3NCT00866775

Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

A Phase 3 study testing Eslicarbazepine acetate in people with Epilepsy With Simple or Complex Partial Onset Seizures, run by Sumitomo Pharma America, Inc. at 106 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy. Read more about this study

Who is it for?
Ages 16 to 70 years
What is being tested?
Eslicarbazepine acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
106 sitesin 2 countries
Study dates
Apr 2009to May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of partial epilepsy as defined in the Classification of Seizures of the International League Against Epilepsy (ILAE) (simple partial seizures with observable motor component, or complex, with or without secondary generalization) a. Medical history of seizures; b. Absence of confounding factors (pseudoseizures, syncope); c. Documented EEG recording (done within 5 years prior to screening) consistent with focal onset epilepsy.
  • Documented CT or MRI scan conducted within 10 years prior to screening, showing the absence of a progressive structural abnormality (eg, tumor). Mesial temporal sclerosis is acceptable.
  • ≥4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure free period.
  • Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.
  • Subjects must have the ability to comprehend the informed consent form and be willing to provide informed consent. For subjects who are unable to comprehend the written consent, a witness/caregiver who is able to describe and provide an understanding of the informed consent to the subject must sign the consent form on behalf of the subject.
  • Subjects must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. Subjects of Asian ancestry are required to give written informed consent for genotyping. All subjects must sign a HIPAA Form. All females of child bearing potential must also sign the "Women of Childbearing Potential" Addendum.
  • A female subject is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); b. Child-bearing potential (all females ≤65 years of age), has a negative pregnancy test at screening and agrees to satisfy contraception requirements.

Who cannot join

  • Subjects with only simple partial seizures without a motor component.
  • Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or Lennox-Gastaut syndrome).
  • History of pseudo-seizures.
  • Current seizures related to an acute medical illness.
  • Seizures secondary to metabolic, toxic or infectious disorder or drug abuse.
  • Status epilepticus within 2 years prior to screening.
Show all 18Show fewer
  • Seizures only occurring in a cluster pattern.
  • Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin, carbamazepine, oxcarbazepine, or lamotrigine.
  • Subjects taking 2 AEDs with both being in the upper dose range (defined as approximately two-thirds of the defined daily dose).
  • Subjects taking more than 2 AEDs.
  • Subjects with progressive structural central nervous system lesion or progressive encephalopathy.
  • Psychiatric exclusion criteria: subjects with history of suicide attempt in last 2 years; major depressive episode within last 6 months; abuse of alcohol or substance abuse in last 2 years; significant psychiatric disorder or recurrent episodes of severe depression within 2 years prior to screening.
  • Medical exclusion criteria: known renal insufficiency or subject with estimated creatinine clearance [CrCL] <60 mL/min based on serum creatinine using the Cockcroft-Gault formula.
  • Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests positive for the presence of the HLA-B*1502 allele.
  • Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular basis within 3 months prior to screening.
  • Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative hypnotics including non-benzodiazepines, central opioid agonists/antagonists, monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2 weeks whichever is longer) prior to randomization.
  • Subjects presently on felbamate or vigabatrin
  • Female subjects who are currently breastfeeding or intending to breastfeed during study period.

Trial locations and contacts

106 sites in 2 countries.

106 sites in 2 countries

United States103 sites

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Neurology Associates of Arlington, PA

    Arlington, Texas, 76017

  • Peachtree Neurological Clinic

    Atlanta, Georgia, 30309

  • Emory University Department of Neurology

    Atlanta, Georgia, 30322

  • PANDA Neurology and Atlanta Headache Specialists

    Atlanta, Georgia, 30328

  • Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045

  • John Hopkins University

    Baltimore, Maryland, 21287

  • Northern Ohio Neurosciences

    Bellevue, Ohio, 44811

  • Neurological Associates of Washington/Clinical Trials of America Inc.

    Bellevue, Washington, 98004

  • Sutter East Bay Medical Foundation

    Berkley, California, 94705

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

  • Norwood Neurology

    Birmingham, Alabama, 35234

  • Greystone Neurology Center

    Birmingham, Alabama, 35242

  • Consultants in Epilepsy and Neurology, PLLC.

    Boise, Idaho, 83702

  • Massachusetts General Hospital Epilepsy Service - WACC

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • Cooper University Health System

    Camden, New Jersey, 08103

  • Five Towns Neuroscience Research

    Cedarhurst, New York, 11516

  • The Neurology Institute

    Charlotte, North Carolina, 28204

  • Cooper University Health System

    Cherry Hill, New Jersey, 08034

  • The Comprehensive Epilepsy Care Center for Children and Adults

    Chesterfield, Missouri, 63017

  • Rush University

    Chicago, Illinois, 60612

  • UCMC

    Chicago, Illinois, 60637

  • Miami Clinical Research

    Coral Gables, Florida, 33134

  • Gus Stratton / Neurology

    Cranston, Rhode Island, 02920

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • Neurological Clinic of Texas P.A.

    Dallas, Texas, 75230

  • Associated Neurologists, PC

    Danbury, Connecticut, 06810

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • NJ Neuroscience Center

    Edison, New Jersey, 08818

  • Synergy Escondido

    Escondido, California, 92025

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Collaborative Neuroscience Network

    Garden Grove, California, 92845

  • Mid-South Physcians Group

    Germantown, Tennessee, 38138

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561

  • North Oaks Neurology

    Hammond, Louisiana, 70403

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • Infiniti Clinical Research, LLC

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • UT Health Science Center at Houston

    Houston, Texas, 77030

  • Todd Swick, MD, PA

    Houston, Texas, 77063

  • University of Florida Health Science Center

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Bluegrass Epilepsy Research LLC

    Lexington, Kentucky, 40504

  • K & S Professional Research Services

    Little Rock, Arkansas, 72201

  • Institute of Neurology and Neurosurgery at St. Bamabas, Suite 101

    Livingston, New Jersey, 07039

  • Faculty of Physicians & Surgeons of Loma Linda University

    Loma Linda, California, 92354

  • Loma Linda University

    Loma Linda, California, 92354

  • American Institute of Research

    Los Gatos, California, 95032

  • Neurology Associates, PA

    Maitland, Florida, 32751

  • Neurology Associates of Arlington, PA

    Mansfield, Texas, 76063

  • Providence Medical Group

    Medford, Oregon, 97504

  • MIMA Century Research Associates

    Melbourne, Florida, 32901

  • San Marcus Research Clinic

    Miami, Florida, 33015

  • Neurosciences Consultants, LLC

    Miami, Florida, 33176

  • Winthrop University Hospital

    Mineola, New York, 11501

  • USA Neurology

    Mobile, Alabama, 36693

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Access Clinical Trials

    Nashville, Tennessee, 37203

  • VU Department of Neurology

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • University of Medicine and Dentistry of New Jersey

    New Brunswick, New Jersey, 08901

  • Beth Israel Medical Center

    New York, New York, 10003

  • Clinilabs Inc.

    New York, New York, 10019

  • Sentara Neurology Specialists

    Norfolk, Virginia, 23507

  • Neurology Clinic, P.C.

    Northport, Alabama, 35476

  • Northridge Neurological Center

    Northridge, California, 91325

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112'

  • 5929 N. May Ave.

    Oklahoma City, Oklahoma, 73112

  • Neurological Services Orlando

    Orlando, Florida, 32806

  • Pediatric Neurolog, PA

    Orlando, Florida, 32819

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Yafa Minazad, DO

    Pasadena, California, 91105

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Children's Hospital Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Clinical Research Consortium

    Phoenix, Arizona, 85003

  • Clinical Research Consortium - Arizona

    Phoenix, Arizona, 85004

  • Xenoscience Inc.

    Phoenix, Arizona, 85004

  • Children's Hospital of Pittsburg of UPMC

    Pittsburgh, Pennsylvania, 15201

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98057

  • University of Rochester

    Rochester, New York, 14642

  • Harbin Clinic

    Rome, Georgia, 30165

  • Neurological Research Institute

    Santa Monica, California, 90404

  • MMP Neurology

    Scarborough, Maine, 04074

  • Pacific Medical Centers

    Seattle, Washington, 98144

  • Southern Illinois University

    Springfield, Illinois, 62702

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Arizona Neurological Institute

    Sun City, Arizona, 85351

  • GA Neurology and Sleep Medicine Associates

    Suwanee, Georgia, 30024

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • Pediatric Epilepsy & Neurology Specialists, PA

    Tampa, Florida, 33609

  • Florida Comprehensive Epilepsy and Seizure Disorder Center

    Tampa, Florida, 33613

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Vero Neurology

    Vero Beach, Florida, 32960

  • Palm Beach Clinical Research Network LLC

    Wellington, Florida, 33414

  • American Institute of Research

    Whittier, California, 90603

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Wake Forest University

    Winstom-Salem, North Carolina, 27157

Other trials in United States

Canada3 sites

  • Neuro-Epilepsy Clinic

    Greenfield Park, Quebec, J4V2J2

  • London Health Sciences Center

    London, Ontario, N6A5A5

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.

Read the detailed description

This is an 18-week, double-blind, randomized, historical control, multicenter study with gradual conversion to monotherapy in subjects with partial onset seizures who are not well controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week period for titration of study drug, 6-week period for taper or conversion off AEDs, and a 10-week monotherapy period. Subjects not entering an optional open-label extension study will enter a 1-week period to taper off study drug followed by an end of study visit (week 19). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Being tested
Eslicarbazepine acetate
Keywords
Seizure, Epilepsy, Anticonvulsant, Historical Control, Monotherapy
Medical subject headings
Seizures, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eslicarbazepine acetateDrug

    1600 mg QD

  • Eslicarbazepine acetateDrug

    1200 mg QD

Study groups in NCT00866775
Study groupRoleWhat they receive
Eslicarbazepine 1600 mg QDExperimentalSubjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg QD (Day 0) to 1200 mg QD (Week 1) to 1600 mg QD (Weeks 2-18) Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.
Receives: Drug: Eslicarbazepine acetate
Eslicarbazepine 1200 mg QDExperimentalSubjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg QD (Day 0) to 800 mg QD (week 1) to 1200 mg QD (weeks 2-18) Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.
Receives: Drug: Eslicarbazepine acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method

    Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.

    Measured: Week 3 to Week 18

Secondary outcomes (15)

  1. Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.

    Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.

    Measured: Weeks 9 through 18

  2. Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.

    Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.

    Measured: Weeks 15 through 18

  3. Completion Rate

    Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.

    Measured: Week 1 to Week 18

  4. Completion Rate During the 10 Weeks of Monotherapy

    Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.

    Measured: Weeks 8 through 18

  5. Time on Eslicarbazepine Acetate Monotherapy.

    The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.

    Measured: Week 8 to Week 18

  6. Change in Seizure Frequency From Baseline.

    The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).

    Measured: Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18

  7. Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).

    Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.

    Measured: Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18

  8. Percentage of Subjects Reaching Each of the Exit Events.

    The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.

    Measured: Week 1 to Week 18

  9. Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).

    The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.

    Measured: Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18

  10. Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).

    The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity

    Measured: Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18

  11. Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.

    The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity

    Measured: Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18

  12. Percentage of Subjects With Increase of Body Weight >= 7%

    Measured: 18 Week Double-blind treatment period

  13. Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L

    Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L

    Measured: 18 Week Double-blind treatment period

  14. Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).

    Measured: 18 Week Double-blind treatment period

  15. Standardized Seizure Frequency (SSF) by Period

    Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).

    Measured: Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866775
Sponsor's protocol ID
093-045
Status last verified
Feb 2016
First submitted
18 Mar 2009
Last updated
11 Mar 2016
Data monitoring committee
No

Publications

  • Sperling MR, Harvey J, Grinnell T, Cheng H, Blum D; 045 Study Team. Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a randomized historical-control phase III study based in North America. Epilepsia. 2015 Apr;56(4):546-55. doi: 10.1111/epi.12934. Epub 2015 Feb 16.

    PubMed 25689448

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eslicarbazepine acetate in people with Epilepsy With Simple or Complex Partial Onset Seizures, run by Sumitomo Pharma America, Inc. at 106 sites in 2 countries.

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 7 inclusion and 18 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method (time frame: Week 3 to Week 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00866775, which also lists 1 linked publication.

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 11 Mar 2016.

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