A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194570
First received: August 28, 2010
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in patients with primary progressive multiple sclerosis. Eligible patients will be randomized 2 : 1 to receive either ocrelizumab (300 mg intravenously, 2 infusions separated by 14 days in each treatment cycle) or placebo. The blinded treatment period will be at least 120 weeks, followed by open label treatment for patients in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Anticipated time on study treatment is up to 5.5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Primary Progressive |
Drug: ocrelizumab Drug: Placebo Drug: methylprednisolone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Efficacy: Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to sustained disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
- Change in timed 25-foot walk [ Time Frame: from baseline to Week 120 ] [ Designated as safety issue: No ]
- Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain [ Time Frame: from baseline to Week 180 ] [ Designated as safety issue: No ]
- Safety and tolerability: Incidence of adverse events [ Time Frame: up to 5.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 630 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: ocrelizumab
2 intravenous infusions of 300 mg separated by 14 days in each treatment cycle
Drug: methylprednisolone
100 mg iv 30 minutes prior to ocrelizumab or placebo infusion
|
| Placebo Comparator: B |
Drug: Placebo
Ocrelizumab placebo, 2 infusions separated by 14 days in each treatment cycle
Drug: methylprednisolone
100 mg iv 30 minutes prior to ocrelizumab or placebo infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, 18-55 years of age
- Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
- Expanded Disability Status Scale (EDSS) 3 to 6.5 points
- Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
- Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Exclusion Criteria:
- History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
- Contraindications for Magnetic Resonance Imaging (MRI)
- Known presence of other neurologic disorders
- Known active infection or history of or presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
- Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
- Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194570
Hide Study Locations
Contacts
| Contact: Please reference Study ID Number: WA25046 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Arizona | |
| Active, not recruiting | |
| Phoenix, Arizona, United States, 85013 | |
| Active, not recruiting | |
| Phoenix, Arizona, United States, 85018 | |
| Active, not recruiting | |
| Phoenix, Arizona, United States, 85050 | |
| Active, not recruiting | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Active, not recruiting | |
| Newport Beach, California, United States, 92663 | |
| Active, not recruiting | |
| Oakland, California, United States, 94609 | |
| Active, not recruiting | |
| Sacramento, California, United States, 95817 | |
| Active, not recruiting | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Active, not recruiting | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Terminated | |
| Bradenton, Florida, United States, 34205 | |
| Terminated | |
| Maitland, Florida, United States, 32751 | |
| Active, not recruiting | |
| Miami, Florida, United States, 33136 | |
| Terminated | |
| Tampa, Florida, United States, 33609 | |
| Active, not recruiting | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Georgia | |
| Terminated | |
| Atlanta, Georgia, United States, 30327 | |
| Terminated | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Terminated | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Active, not recruiting | |
| Kansas City, Kansas, United States, 66160 | |
| Active, not recruiting | |
| Lenexa, Kansas, United States, 66214 | |
| United States, Michigan | |
| Active, not recruiting | |
| Detroit, Michigan, United States, 48201 | |
| Active, not recruiting | |
| Detroit, Michigan, United States, 48202 | |
| Active, not recruiting | |
| Farmington Hills, Michigan, United States, 48334 | |
| Active, not recruiting | |
| Minneapolis, Michigan, United States, 55455 | |
| United States, Minnesota | |
| Terminated | |
| Golden Valley, Minnesota, United States, 55422 | |
| United States, Missouri | |
| Active, not recruiting | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Active, not recruiting | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New Mexico | |
| Active, not recruiting | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Terminated | |
| Albany, New York, United States, 12208 | |
| Completed | |
| Mineola, New York, United States, 11501 | |
| Active, not recruiting | |
| New York, New York, United States, 10029 | |
| Active, not recruiting | |
| New York, New York, United States, 10021 | |
| Active, not recruiting | |
| Patchogue, New York, United States, 11772 | |
| Terminated | |
| Rochester, New York, United States, 14642 | |
| Active, not recruiting | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Terminated | |
| Advance, North Carolina, United States, 27006 | |
| Active, not recruiting | |
| Charlotte, North Carolina, United States, 28207 | |
| Active, not recruiting | |
| Raleigh, North Carolina, United States, 27607-6010 | |
| United States, Ohio | |
| Active, not recruiting | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Active, not recruiting | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Terminated | |
| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
| Active, not recruiting | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Active, not recruiting | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| Active, not recruiting | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Active, not recruiting | |
| Dallas, Texas, United States, 75390-9063 | |
| Active, not recruiting | |
| Houston, Texas, United States, 77030 | |
| Terminated | |
| Round Rock, Texas, United States, 78681 | |
| United States, Virginia | |
| Active, not recruiting | |
| Henrico, Virginia, United States, 23226 | |
| United States, Washington | |
| Active, not recruiting | |
| Seattle, Washington, United States, 98122 | |
| United States, Wisconsin | |
| Terminated | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Australia | |
| Active, not recruiting | |
| Fitzroy, Australia, 3065 | |
| Terminated | |
| Heidelberg, Australia, 3084 | |
| Active, not recruiting | |
| Hobart, Australia, 7000 | |
| Austria | |
| Active, not recruiting | |
| Innsbruck, Austria, 6020 | |
| Active, not recruiting | |
| Linz, Austria, 4021 | |
| Active, not recruiting | |
| Linz, Austria, 4020 | |
| Active, not recruiting | |
| Salzburg, Austria, 5020 | |
| Terminated | |
| Villach, Austria, 9500 | |
| Active, not recruiting | |
| Wien, Austria, 1090 | |
| Belgium | |
| Active, not recruiting | |
| La Louviere, Belgium, 7100 | |
| Terminated | |
| Leuven, Belgium, 3000 | |
| Active, not recruiting | |
| Sijsele-damme, Belgium, 8340 | |
| Brazil | |
| Active, not recruiting | |
| Belo Horizonte, Brazil, 30150-221 | |
| Active, not recruiting | |
| Goiânia, Brazil, 74605-020 | |
| Active, not recruiting | |
| Porto Alegre, Brazil, 90610-000 | |
| Active, not recruiting | |
| Rio de Janeiro, Brazil, 22290-240 | |
| Bulgaria | |
| Terminated | |
| Pleven, Bulgaria, 5800 | |
| Active, not recruiting | |
| Sofia, Bulgaria, 1309 | |
| Active, not recruiting | |
| Sofia, Bulgaria, 1113 | |
| Terminated | |
| Sofia, Bulgaria, 1407 | |
| Canada, Alberta | |
| Active, not recruiting | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| Active, not recruiting | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Manitoba | |
| Active, not recruiting | |
| Winnipeg, Manitoba, Canada, R8A 1R9 | |
| Canada, Ontario | |
| Active, not recruiting | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Active, not recruiting | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Terminated | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Active, not recruiting | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Active, not recruiting | |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Czech Republic | |
| Active, not recruiting | |
| Brno, Czech Republic, 625 00 | |
| Active, not recruiting | |
| Praha 2, Czech Republic, 128 08 | |
| Active, not recruiting | |
| Teplice, Czech Republic, 415 29 | |
| Denmark | |
| Terminated | |
| Sonderborg, Denmark, 6400 | |
| Finland | |
| Active, not recruiting | |
| Helsinki, Finland, 00290 | |
| Active, not recruiting | |
| Tampere, Finland, 33520 | |
| Recruiting | |
| Turku, Finland, 20100 | |
| Active, not recruiting | |
| Turku, Finland, 20520 | |
| France | |
| Terminated | |
| Besancon, France, 25030 | |
| Active, not recruiting | |
| Bordeaux, France, 33076 | |
| Active, not recruiting | |
| Caen, France, 14033 | |
| Active, not recruiting | |
| Clermont-ferrand, France, 63003 | |
| Active, not recruiting | |
| Lille, France, 59037 | |
| Active, not recruiting | |
| Lyon, France, 69394 | |
| Active, not recruiting | |
| Marseille, France, 13005 | |
| Active, not recruiting | |
| Montpellier, France, 34295 | |
| Active, not recruiting | |
| Nancy, France, 54035 | |
| Active, not recruiting | |
| Nantes, France, 44805 | |
| Active, not recruiting | |
| Nice, France, 06002 | |
| Active, not recruiting | |
| Nimes, France, 30029 | |
| Active, not recruiting | |
| Paris, France, 75651 | |
| Active, not recruiting | |
| Paris, France, 75019 | |
| Active, not recruiting | |
| Poissy, France, 78300 | |
| Active, not recruiting | |
| Reims, France, 51092 | |
| Active, not recruiting | |
| Strasbourg, France, 67091 | |
| Active, not recruiting | |
| Toulouse, France, 31059 | |
| Germany | |
| Active, not recruiting | |
| Bayreuth, Germany, 95445 | |
| Active, not recruiting | |
| Berg, Germany, 82335 | |
| Active, not recruiting | |
| Berlin, Germany, 10117 | |
| Active, not recruiting | |
| Berlin, Germany, 13347 | |
| Active, not recruiting | |
| Bochum, Germany, 06097 | |
| Active, not recruiting | |
| Dresden, Germany, 01307 | |
| Active, not recruiting | |
| Düsseldorf, Germany, 40225 | |
| Active, not recruiting | |
| Frankfurt, Germany, 60528 | |
| Active, not recruiting | |
| GIEßEN, Germany, 35385 | |
| Active, not recruiting | |
| Heidelberg, Germany, 69115 | |
| Active, not recruiting | |
| Köln, Germany, 51067 | |
| Active, not recruiting | |
| Leipzig, Germany, 04103 | |
| Terminated | |
| Marburg, Germany, 35032 | |
| Active, not recruiting | |
| Munich, Germany, 81675 | |
| Active, not recruiting | |
| Münster, Germany, 48149 | |
| Active, not recruiting | |
| Regensburg, Germany, 93053 | |
| Active, not recruiting | |
| Tübingen, Germany, 72076 | |
| Active, not recruiting | |
| ULM, Germany, 89081 | |
| Active, not recruiting | |
| Wiesbaden, Germany, 65191 | |
| Greece | |
| Active, not recruiting | |
| Athens, Greece, 11525 | |
| Active, not recruiting | |
| Thessaloniki, Greece, 54636 | |
| Active, not recruiting | |
| Thessaloniki, Greece, 57010 | |
| Hungary | |
| Active, not recruiting | |
| Budapest, Hungary, 1145 | |
| Active, not recruiting | |
| Budapest, Hungary, 1204 | |
| Terminated | |
| Budapest, Hungary, 1033 | |
| Active, not recruiting | |
| Esztergom, Hungary, 2500 | |
| Active, not recruiting | |
| Pécs, Hungary, 7623 | |
| Active, not recruiting | |
| Szeged, Hungary, 6720 | |
| Recruiting | |
| Veszprem, Hungary, 8200 | |
| Israel | |
| Active, not recruiting | |
| Ashkelon, Israel, 78278 | |
| Terminated | |
| Haifa, Israel, 31048 | |
| Active, not recruiting | |
| Petach Tikva, Israel, 49100 | |
| Active, not recruiting | |
| Ramat-gan, Israel, 52621 | |
| Active, not recruiting | |
| Safed, Israel, 13100 | |
| Active, not recruiting | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Active, not recruiting | |
| Cagliari, Italy, 09126 | |
| Active, not recruiting | |
| Genova, Italy, 16132 | |
| Active, not recruiting | |
| Milano, Italy, 20132 | |
| Active, not recruiting | |
| Orbassano, Italy, 10043 | |
| Lithuania | |
| Active, not recruiting | |
| Kaunas, Lithuania, 50009 | |
| Active, not recruiting | |
| Klaipeda, Lithuania, 92288 | |
| Active, not recruiting | |
| Siauliai, Lithuania, LT-76231 | |
| Mexico | |
| Active, not recruiting | |
| Aguascalientes, Mexico, 20127 | |
| Active, not recruiting | |
| Mexico, Mexico, 03600 | |
| Active, not recruiting | |
| Mexico City, Mexico, 14390 | |
| Active, not recruiting | |
| Monterrey, Mexico, 64620 | |
| Netherlands | |
| Active, not recruiting | |
| Rotterdam, Netherlands, 3015 CE | |
| Active, not recruiting | |
| Sittard-geleen, Netherlands, 6162 BG | |
| New Zealand | |
| Active, not recruiting | |
| Hamilton, New Zealand, 3240 | |
| Active, not recruiting | |
| Wellington, New Zealand, 6021 | |
| Norway | |
| Active, not recruiting | |
| Oslo, Norway, 0407 | |
| Peru | |
| Active, not recruiting | |
| Bellavista, Peru, Callao 2 | |
| Active, not recruiting | |
| Lima, Peru, Lima 1 | |
| Active, not recruiting | |
| San Isidro, Peru, Lima 27 | |
| Poland | |
| Active, not recruiting | |
| Bialystok, Poland, 15-402 | |
| Active, not recruiting | |
| Jaroslaw, Poland, 37-500 | |
| Active, not recruiting | |
| Katowice, Poland, 40-752 | |
| Active, not recruiting | |
| Katowice, Poland, 40-594 | |
| Active, not recruiting | |
| Konskie, Poland, 26-200 | |
| Active, not recruiting | |
| Lodz, Poland, 90-153 | |
| Active, not recruiting | |
| Lublin, Poland, 20-954 | |
| Terminated | |
| Plewiska, Poland, 62-064 | |
| Terminated | |
| Poznan, Poland, 60-355 | |
| Portugal | |
| Active, not recruiting | |
| Almada, Portugal, 2801-951 | |
| Active, not recruiting | |
| Amadora, Portugal, 2720-276 | |
| Active, not recruiting | |
| Coimbra, Portugal, 3041-801 | |
| Active, not recruiting | |
| Coimbra, Portugal, 3000-075 | |
| Active, not recruiting | |
| Lisboa, Portugal, 1649-035 | |
| Terminated | |
| Lisboa, Portugal, 1169-050 | |
| Active, not recruiting | |
| Porto, Portugal, 4099-001 | |
| Romania | |
| Active, not recruiting | |
| Bucharest, Romania, 011461 | |
| Terminated | |
| Bucharest, Romania, 060011 | |
| Active, not recruiting | |
| Campulung, Romania, 115100 | |
| Active, not recruiting | |
| Targu Mures, Romania, 50 | |
| Active, not recruiting | |
| Timisoara, Romania, 300736 | |
| Russian Federation | |
| Active, not recruiting | |
| Kazan, Russian Federation, 420103 | |
| Spain | |
| Active, not recruiting | |
| Alicante, Spain, 03010 | |
| Active, not recruiting | |
| Barcelona, Spain, 08032 | |
| Active, not recruiting | |
| Barcelona, Spain, 08025 | |
| Active, not recruiting | |
| Barcelona, Spain, 08035 | |
| Active, not recruiting | |
| Barcelona, Spain, 08003 | |
| Active, not recruiting | |
| Bilbao, Spain, 48013 | |
| Active, not recruiting | |
| Girona, Spain, 17007 | |
| Active, not recruiting | |
| Madrid, Spain, 28040 | |
| Active, not recruiting | |
| Madrid, Spain, 28034 | |
| Active, not recruiting | |
| Madrid, Spain, 28006 | |
| Active, not recruiting | |
| Malaga, Spain, 29010 | |
| Active, not recruiting | |
| San Sebastian, Spain, 20014 | |
| Active, not recruiting | |
| Santiago de Compostela, Spain, 15706 | |
| Active, not recruiting | |
| Sevilla, Spain, 41009 | |
| Switzerland | |
| Active, not recruiting | |
| Basel, Switzerland, 4031 | |
| Active, not recruiting | |
| Lugano, Switzerland, 6903 | |
| Terminated | |
| Zürich, Switzerland, 8091 | |
| Turkey | |
| Terminated | |
| Ankara, Turkey, 06100 | |
| Terminated | |
| Edirne, Turkey, 22030 | |
| Terminated | |
| Kocaeli, Turkey, 41380 | |
| Ukraine | |
| Active, not recruiting | |
| Chernivtsi, Ukraine, 58000 | |
| Active, not recruiting | |
| Dnipropetrovsk, Ukraine, 49044 | |
| Active, not recruiting | |
| Dnipropetrovsk, Ukraine, 49027 | |
| Active, not recruiting | |
| Kharkiv, Ukraine, 61018 | |
| Active, not recruiting | |
| Kharkov, Ukraine, 61068 | |
| Active, not recruiting | |
| Kiev, Ukraine, 04107 | |
| Active, not recruiting | |
| Kyiv, Ukraine, 03110 | |
| Terminated | |
| Lutsk, Ukraine, 43024 | |
| Active, not recruiting | |
| Lutsk, Ukraine, 43024 | |
| Active, not recruiting | |
| Lviv, Ukraine, 79010 | |
| Active, not recruiting | |
| Odesa, Ukraine, 65117 | |
| Terminated | |
| Ternopil, Ukraine, 46027 | |
| Active, not recruiting | |
| Vinnytsya, Ukraine, 21018 | |
| United Kingdom | |
| Active, not recruiting | |
| Liverpool, United Kingdom, L9 1AE | |
| Active, not recruiting | |
| London, United Kingdom, E1 2ES | |
| Active, not recruiting | |
| London, United Kingdom, SE5 9RS | |
| Active, not recruiting | |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Active, not recruiting | |
| Nottingham, United Kingdom, NG7 2UH | |
| Uruguay | |
| Active, not recruiting | |
| Indianapolis, Uruguay, 46202 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01194570 History of Changes |
| Other Study ID Numbers: | WA25046, 2010-020338-25 |
| Study First Received: | August 28, 2010 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Peru: Instituto Nacional de Salud (INS) |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Chronic Progressive Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone |
Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 21, 2013