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Relapsing Forms of Multiple SclerosisPhase 4EPOCNCT01216072

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

A Phase 4 study testing Fingolimod and Standard MS DMTs in people with Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 149 sites in 3 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

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsing Forms of Multiple Sclerosis
What is being tested?
Fingolimod and Standard MS DMTs
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,053 participants
Where
149 sitesin 3 countries
Study dates
Aug 2010to Aug 2012
Phase
Phase 4
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsing forms of MS
  • Expanded Disability Status Scale (EDSS) 0-5.5
  • Continuous treatment with MS DMT for a minimum of 6 months
  • Fingolimod naive

Who cannot join

  • Immune system diseases other than MS
  • Active macular edema
  • History of selected prior infections and criteria for immunizations
  • History of selected immune system treatments and/or medications
  • Selected cardiovascular, pulmonary, or hepatic conditions
  • Selected abnormal laboratory values
  • Pregnant or nursing women
  • Other protocol-defined inclusion/exclusion criteria applied

Trial locations and contacts

149 sites in 3 countries.

149 sites in 3 countries

United States142 sites

  • Novartis Investigative Site

    Akron, Ohio, 44320

  • Novartis Investigative Site

    Amherst, New York, 14226

  • Novartis Investigative Site

    Anaheim, California, 92801

  • Novartis Investigative Site

    Anderson, Indiana, 46011

  • Novartis Investigative Site

    Asheville, North Carolina, 28806

  • Novartis Investigative Site

    Atlanta, Georgia, 30302

  • Novartis Investigative Site

    Atlanta, Georgia, 30309

  • Novartis Investigative Site

    Atlantis, Florida, 33462-6608

  • Novartis Investigative Site

    Austin, Texas, 78756

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70809

  • Novartis Investigative Site

    Bellevue, Ohio, 44811

  • Novartis Investigative Site

    Berkeley, California, 94705

  • Novartis Investigative Site

    Bethesda, Maryland, 20814

  • Novartis Investigative Site

    Beufort, South Carolina, 29902

  • Novartis Investigative Site

    Billings, Montana, 59102

  • Novartis Investigative Site

    Birmingham, Alabama, 35209

  • Novartis Investigative Site

    Bolivar, Missouri, 65613

  • Novartis Investigative Site

    Boston, Massachusetts, 02135

  • Novartis Investigative Site

    Boulder, Colorado, 80304

  • Novartis Investigative Site

    Bradenton, Florida, 32405

  • Novartis Investigative Site

    Burlington, North Carolina, 27215

  • Novartis Investigative Site

    Canton, Ohio, 44718

  • Novartis Investigative Site

    Charlotte, North Carolina, 28204

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219

  • Novartis Investigative Site

    Colleyville, Texas, 76034

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80920

  • Novartis Investigative Site

    Columbia, Tennessee, 38401

  • Novartis Investigative Site

    Columbus, Georgia, 31901

  • Novartis Investigative Site

    Columbus, Ohio, 43221

  • Novartis Investigative Site

    Cordova, Tennessee, 38018

  • Novartis Investigative Site

    Corvallis, Oregon, 97330

  • Novartis Investigative Site

    Cullman, Alabama, 35058

  • Novartis Investigative Site

    Dallas, Texas, 75204

  • Novartis Investigative Site

    Decatur, Georgia, 30083

  • Novartis Investigative Site

    Des Moines, Iowa, 50314-2611

  • Novartis Investigative Site

    Destrehan, Louisiana, 70047

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Doral, Florida, 33166

  • Novartis Investigative Site

    Dover, Delaware, 19901

  • Novartis Investigative Site

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Eugene, Oregon, 97401

  • Novartis Investigative Site

    Evanston, Illinois, 60201

  • Novartis Investigative Site

    Fairfield, Connecticut, 06824

  • Novartis Investigative Site

    Flossmoor, Illinois, 60422

  • Novartis Investigative Site

    Fort Collins, Colorado, 80528

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33308

  • Novartis Investigative Site

    Freehold, New Jersey, 07728

  • Novartis Investigative Site

    Fresno, California, 93710

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Grand Rapids, Michigan, 49503

  • Novartis Investigative Site

    Greensboro, North Carolina, 27401

  • Novartis Investigative Site

    Greenville, North Carolina, 27834

  • Novartis Investigative Site

    Hammond, Louisiana, 70403

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Houston, Texas, 77025

  • Novartis Investigative Site

    Idaho Falls, Idaho, 83402

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202-5111

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Jacksonville, Florida, 32209

  • Novartis Investigative Site

    Jacksonville, Florida, 32216

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49007

  • Novartis Investigative Site

    Kansas City, Missouri, 64111

  • Novartis Investigative Site

    Kansas City, Missouri, 64132

  • Novartis Investigative Site

    Kirkland, Washington, 98034

  • Novartis Investigative Site

    Knoxville, Tennessee, 37934

  • Novartis Investigative Site

    La Habra, California, 90631

  • Novartis Investigative Site

    Latham, New York, 12110

  • Novartis Investigative Site

    Lenexa, Kansas, 66214

  • Novartis Investigative Site

    Lighthouse PT, Florida, 33064

  • Novartis Investigative Site

    Loma Linda, California, 92354

  • Novartis Investigative Site

    Lubbock, Texas, 79410

  • Novartis Investigative Site

    Maitland, Florida, 32751

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Merrillville, Indiana, 46410

  • Novartis Investigative Site

    Metairie, Louisiana, 70001

  • Novartis Investigative Site

    Miami, Florida, 33015

  • Novartis Investigative Site

    Miami, Florida, 33133

  • Novartis Investigative Site

    Monroeville, Pennsylvania, 15146

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506-9260

  • Novartis Investigative Site

    Nashville, Tennessee, 37205

  • Novartis Investigative Site

    New London, Connecticut, 06320

  • Novartis Investigative Site

    New York, New York, 10023

  • Novartis Investigative Site

    Newark, Delaware, 19713

  • Novartis Investigative Site

    Newport Beach, California, 92660

  • Novartis Investigative Site

    Newport News, Virginia, 23606

  • Novartis Investigative Site

    Nixa, Missouri, 65714-7807

  • Novartis Investigative Site

    North Kansas City, Missouri, 64116

  • Novartis Investigative Site

    Northbrook, Illinois, 60062

  • Novartis Investigative Site

    Oceanside, California, 92056

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Novartis Investigative Site

    Patchogue, New York, 11772

  • Novartis Investigative Site

    Phoenix, Arizona, 85004

  • Novartis Investigative Site

    Phoenix, Arizona, 85006

  • Novartis Investigative Site

    Phoenix, Arizona, 85013

  • Novartis Investigative Site

    Phoenix, Arizona, 85032

  • Novartis Investigative Site

    Plainview, New York, 11803

  • Novartis Investigative Site

    Plano, Texas, 75075

  • Novartis Investigative Site

    Pompano Beach, Florida, 33060

  • Novartis Investigative Site

    Ponte Vedra Beach, Florida, 32082-4627

  • Novartis Investigative Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    Portland, Oregon, 97223

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Richmond, Virginia, 23226

  • Novartis Investigative Site

    Roanoke, Virginia, 24014

  • Novartis Investigative Site

    Round Rock, Texas, 78681

  • Novartis Investigative Site

    Rumford, Rhode Island, 02916

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    Salisbury, North Carolina, 28144

  • Novartis Investigative Site

    Salt Lake City, Utah, 84103

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Antonio, Texas, 78258

  • Novartis Investigative Site

    Sarasota, Florida, 34243

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    Seattle, Washington, 98144

  • Novartis Investigative Site

    Sherman, Texas, 75092

  • Novartis Investigative Site

    Shreveport, Louisiana, 71101

  • Novartis Investigative Site

    Shreveport, Louisiana, 71130

  • Novartis Investigative Site

    Somerset, New Jersey, 08873

  • Novartis Investigative Site

    Southfield, Michigan, 48034

  • Novartis Investigative Site

    Springfield, Massachusetts, 01104

  • Novartis Investigative Site

    St Louis, Missouri, 63104

  • Novartis Investigative Site

    St. Petersburg, Florida, 33713

  • Novartis Investigative Site

    Stratford, Connecticut, 06615

  • Novartis Investigative Site

    Sunrise, Florida, 33351

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tampa, Florida, 33609

  • Novartis Investigative Site

    Tampa, Florida, 33612

  • Novartis Investigative Site

    Teaneck, New Jersey, 07666

  • Novartis Investigative Site

    Toms River, New Jersey, 08755

  • Novartis Investigative Site

    Tucson, Arizona, 85741

  • Novartis Investigative Site

    Uniontown, Ohio, 44685

  • Novartis Investigative Site

    Valparaiso, Indiana, 46383

  • Novartis Investigative Site

    Vero Beach, Florida, 32960

  • Novartis Investigative Site

    Vienna, Virginia, 22182

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    West Palm Beach, Florida, 33407

  • Novartis Investigative Site

    Wilmington, North Carolina, 28401

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

  • Novartis Investigative Site

    Worcester, Massachusetts, 01608

  • Novartis Investigative Site

    Worcester, Massachusetts, 01665

Other trials in United States

Canada6 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 2T9

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2J2

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Montreal, Quebec, H3A 2B4

  • Novartis Investigative Site

    Nepean, Ontario, K2G 6E2

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Puerto Rico1 site

  • Novartis Investigative Site

    Guaynabo, 00969

Other trials in Puerto Rico

About this study

Official title: A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

Being tested
Fingolimod, Standard MS DMTs
Keywords
Relapsing Forms of Multiple Sclerosis, Disease Modifying Therapy, fingolimod, Patient Reported Outcomes

What participants receive

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

  • FingolimodDrug

    Also called GILENYA™

    0.5 mg/day oral capsule

  • Standard MS DMTsDrug

    Also called Avonex®,, Copaxone®,, Rebif®,, Betaseron®,

Study groups in NCT01216072
Study groupRoleWhat they receive
FingolimodExperimentalPatients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period .
Receives: Drug: Fingolimod
Multiple Sclerosis Disease Modifying Treatments (MS DMTs)Active comparatorPatients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Receives: Drug: Standard MS DMTs

What is being measured

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

  1. Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6

    The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

    Measured: Baseline, Month 6

Secondary outcomes (9)

  1. Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death

    In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

    Measured: 9 months (6 month core + 3 month Extension)

  2. Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6

    The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.

    Measured: Baseline, Month 6

  3. Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)

    The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.

    Measured: Baseline, Month 3, Month 6

  4. Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4

    The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

    Measured: Baseline, Month 6

  5. Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4

    The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

    Measured: Baseline, Month 6

  6. Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4

    The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.

    Measured: Baseline, Month 6

  7. Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)

    The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.

    Measured: Baseline, Month 6

  8. Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)

    The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.

    Measured: Baseline, Month 3, Month 6

  9. Physician-reported Clinical Global Impression of Improvement (CGI-I)

    The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.

    Measured: Month 3, Month 6

Timeline

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

  1. First posted7 Oct 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01216072
Sponsor's protocol ID
CFTY720DUS01
Acronym
EPOC
Status last verified
Jan 2014
First submitted
7 Sep 2010
Last updated
10 Feb 2014

Publications

  • Hughes B, Cascione M, Freedman MS, Agius M, Kantor D, Gudesblatt M, Goldstick LP, Agashivala N, Schofield L, McCague K, Hashmonay R, Barbato L; EPOC study investigators. First-dose effects of fingolimod after switching from injectable therapies in the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):620-8. doi: 10.1016/j.msard.2014.06.006. Epub 2014 Jul 3.

    PubMed 26265274

  • Fox E, Edwards K, Burch G, Wynn DR, LaGanke C, Crayton H, Hunter SF, Huffman C, Kim E, Pestreich L, McCague K, Barbato L; EPOC study investigators. Outcomes of switching directly to oral fingolimod from injectable therapies: Results of the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):607-19. doi: 10.1016/j.msard.2014.06.005. Epub 2014 Jul 4.

    PubMed 26265273

  • Calkwood J, Cree B, Crayton H, Kantor D, Steingo B, Barbato L, Hashmonay R, Agashivala N, McCague K, Tenenbaum N, Edwards K. Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial. BMC Neurol. 2014 Nov 26;14:220. doi: 10.1186/s12883-014-0220-1.

    PubMed 25424122

  • Cascione M, Wynn D, Barbato LM, Pestreich L, Schofield L, McCague K. Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design. J Med Econ. 2013 Jul;16(7):859-65. doi: 10.3111/13696998.2013.802239. Epub 2013 May 20.

    PubMed 23647445

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod and Standard MS DMTs in people with Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 149 sites in 3 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 4 inclusion and 8 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Canada, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Dec 2013). 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?

Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (time frame: Baseline, Month 6). 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 NCT01216072, which also lists 4 linked publications.

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 10 Feb 2014.

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