A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo
This trial is active, not recruiting.
|Condition||primary progressive multiple sclerosis|
|Sponsor||Teva Pharmaceutical Industries|
|Start date||January 2015|
|End date||September 2017|
|Trial size||374 participants|
|Trial identifier||NCT02284568, 2014-001579-30, TV5600-CNS-20006|
This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||Teva Investigational Site 12966||no longer recruiting|
|Tucson, AZ||Teva Investigational Site 1512972||no longer recruiting|
|Newport Beach, CA||Teva Investigational Site 12967||no longer recruiting|
|San Francisco, CA||Teva Investigational Site 12962||no longer recruiting|
|Aurora, CO||Teva Investigational Site 12964||no longer recruiting|
|Northbrook, IL||Teva Investigational Site 12973||no longer recruiting|
|Kansas City, KS||Teva Investigational Site 12975||no longer recruiting|
|Lenexa, KS||Teva Investigational Site 12969||no longer recruiting|
|Golden Valley, MN||Teva Investigational Site 12977||no longer recruiting|
|Golden Valley, MN||Teva Investigational Site 13010||no longer recruiting|
|Chesterfield, MO||Teva Investigational Site 12965||no longer recruiting|
|St Louis, MO||Teva Investigational Site 12968||no longer recruiting|
|New York, NY||Teva Investigational Site 12963||no longer recruiting|
|Charlotte, NC||Teva Investigational Site 12971||no longer recruiting|
|Columbus, OH||Teva Investigational Site 12976||no longer recruiting|
|Uniontown, OH||Teva Investigational Site 12970||no longer recruiting|
|Halifax, Canada||Teva Investigational Site 11084||no longer recruiting|
|Montreal, Canada||Teva Investigational Site 11082||no longer recruiting|
|Calgary, Canada||Teva Investigational Site 11089||no longer recruiting|
|Ottawa, Canada||Teva Investigational Site 11081||no longer recruiting|
|Quebec, Canada||Teva Investigational Site 11088||no longer recruiting|
|Toronto, Canada||Teva Investigational Site 11087||no longer recruiting|
|Bad Mergentheim, Germany||Teva Investigational Site 32505||no longer recruiting|
|Bamberg, Germany||Teva Investigational Site 32512||no longer recruiting|
|Berlin, Germany||Teva Investigational Site 32510||no longer recruiting|
|Bochum, Germany||Teva Investigational Site 32522||no longer recruiting|
|Dresden, Germany||Teva Investigational Site 32509||no longer recruiting|
|Düsseldorf, Germany||Teva Investigational Site 32517||no longer recruiting|
|Goettingen, Germany||Teva Investigational Site 32543||no longer recruiting|
|Hamburg, Germany||Teva Investigational Site 32514||no longer recruiting|
|Hannover, Germany||Teva Investigational Site 32507||no longer recruiting|
|Munchen, Germany||Teva Investigational Site 32504||no longer recruiting|
|Munchen, Germany||Teva Investigational Site 32513||no longer recruiting|
|Rostock, Germany||Teva Investigational Site 32516||no longer recruiting|
|Trier, Germany||Teva Investigational Site 32523||no longer recruiting|
|Ulm, Germany||Teva Investigational Site 32503||no longer recruiting|
|Würzburg, Germany||Teva Investigational Site 32511||no longer recruiting|
|Cefalù (Palermo), Italy||Teva Investigational Site 30106||no longer recruiting|
|Firenze, Italy||Teva Investigational Site 30110||no longer recruiting|
|Gallarate (Varese), Italy||Teva Investigational Site 30105||no longer recruiting|
|Genova, Italy||Teva Investigational Site 30108||no longer recruiting|
|Milano, Italy||Teva Investigational Site 30102||no longer recruiting|
|Orbassano (Torino), Italy||Teva Investigational Site 30107||no longer recruiting|
|Padova, Italy||Teva Investigational Site 30103||no longer recruiting|
|Roma, Italy||Teva Investigational Site 30101||no longer recruiting|
|Roma, Italy||Teva Investigational Site 30104||no longer recruiting|
|Amsterdan, Netherlands||Teva Investigational Site 38068||no longer recruiting|
|Nijmegen, Netherlands||Teva Investigational Site 38067||no longer recruiting|
|Sittard-Geleen, Netherlands||Teva Investigational Site 38069||no longer recruiting|
|Bialystok, Poland||Teva Investigational Site 53262||no longer recruiting|
|Bydgoszcz, Poland||Teva Investigational Site 53250||no longer recruiting|
|Gdansk, Poland||Teva Investigational Site 53253||no longer recruiting|
|Katowice, Poland||Teva Investigational Site 53256||no longer recruiting|
|Katowice, Poland||Teva Investigational Site 53257||no longer recruiting|
|Katowice, Poland||Teva Investigational Site 53258||no longer recruiting|
|Kielce, Poland||Teva Investigational Site 53255||no longer recruiting|
|Konskie, Poland||Teva Investigational Site 53251||no longer recruiting|
|Lublin, Poland||Teva Investigational Site 53260||no longer recruiting|
|Olsztyn, Poland||Teva Investigational Site 53261||no longer recruiting|
|Warsaw, Poland||Teva Investigational Site 53252||no longer recruiting|
|Kaluga, Russian Federation||Teva Investigational Site 50285||no longer recruiting|
|Kazan, Russian Federation||Teva Investigational Site 50288||no longer recruiting|
|Kazan, Russian Federation||Teva Investigational Site 50290||no longer recruiting|
|Kirov, Russian Federation||Teva Investigational Site 50294||no longer recruiting|
|Krasnoyarsk, Russian Federation||Teva Investigational Site 50292||no longer recruiting|
|Moscow, Russian Federation||Teva Investigational Site 50287||no longer recruiting|
|Nizhny Novgorod, Russian Federation||Teva Investigational Site 50291||no longer recruiting|
|Novosibirsk, Russian Federation||Teva Investigational Site 50286||no longer recruiting|
|Perm, Russian Federation||Teva Investigational Site 50295||no longer recruiting|
|Saint Petersburg, Russian Federation||Teva Investigational Site 50293||no longer recruiting|
|St. Petersburg, Russian Federation||Teva Investigational Site 50289||no longer recruiting|
|Barcelona, Spain||Teva Investigational Site 31106||no longer recruiting|
|Barcelona, Spain||Teva Investigational Site 31108||no longer recruiting|
|El Palmar, Spain||Teva Investigational Site 31105||no longer recruiting|
|Getafe, Spain||Teva Investigational Site 31103||no longer recruiting|
|Lleida, Spain||Teva Investigational Site 31111||no longer recruiting|
|Madrid, Spain||Teva Investigational Site 31112||no longer recruiting|
|Malaga, Spain||Teva Investigational Site 31101||no longer recruiting|
|Pozuelo de Alarcon, Spain||Teva Investigational Site 31192||no longer recruiting|
|San Sebastian, Spain||Teva Investigational Site 31104||no longer recruiting|
|Sevilla, Spain||Teva Investigational Site 31102||no longer recruiting|
|Valencia, Spain||Teva Investigational Site 31100||no longer recruiting|
|Dnipropetrovsk, Ukraine||Teva Investigational Site 58158||no longer recruiting|
|Ivano-Frankivsk, Ukraine||Teva Investigational Site 58159||no longer recruiting|
|Kharkiv, Ukraine||Teva Investigational Site 58157||no longer recruiting|
|Kyiv, Ukraine||Teva Investigational Site 58160||no longer recruiting|
|Lutsk, Ukraine||Teva Investigational Site 58152||no longer recruiting|
|Lviv, Ukraine||Teva Investigational Site 58153||no longer recruiting|
|Lviv, Ukraine||Teva Investigational Site 58154||no longer recruiting|
|Zaporizhzhia, Ukraine||Teva Investigational Site 58156||no longer recruiting|
|Zaporizhzhya, Ukraine||Teva Investigational Site 58150||no longer recruiting|
|Zaporizhzhya, Ukraine||Teva Investigational Site 58151||no longer recruiting|
|Bristol, United Kingdom||Teva Investigational Site 34190||no longer recruiting|
|Devon, United Kingdom||Teva Investigational Site 34189||no longer recruiting|
|Edinburgh, United Kingdom||Teva Investigational Site 34188||no longer recruiting|
|Liverpool, United Kingdom||Teva Investigational Site 34182||no longer recruiting|
|London, United Kingdom||Teva Investigational Site 34181||no longer recruiting|
|Nottingham, United Kingdom||Teva Investigational Site 34183||no longer recruiting|
|Oxford, United Kingdom||Teva Investigational Site 34184||no longer recruiting|
|Plymouth, United Kingdom||Teva Investigational Site 34186||no longer recruiting|
|Stoke-on-Trent, United Kingdom||Teva Investigational Site 34185||no longer recruiting|
|Swansea, United Kingdom||Teva Investigational Site 34187||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Percent brain volume change (PBVC)
time frame: 48 weeks
Time to confirmed disability progression (CDP)
time frame: 48 weeks
Change from baseline in timed 25 foot walk
time frame: Baseline, Week 48
Number of new T2 brain lesions
time frame: 48 weeks
Male or female participants from 25 years up to 55 years old.
- Patients must have a confirmed and documented PPMS diagnosis as defined by the 2010 Revised McDonald criteria
- Baseline magnetic resonance imaging (MRI) showing lesions consistent with PPMS in either or both brain and spinal cord
- Patients must have an Expanded Disability Status Scale (EDSS) score of 3 to 6.5, inclusive, at both screening and baseline visits
- Documented evidence of clinical disability progression in the 2 years prior to screening.
- Functional System Score (FSS) of > or equal 2 for the pyramidal system or gait impairment due to lower extremity dysfunction
- Patients must be between 25 to 55 years of age, inclusive
- Women of child-bearing potential must practice an acceptable method of birth control for 30 days before taking the study drug, and 2 acceptable methods of birth control during all study duration and until 30 days after the last dose of treatment is administered.
- Patients must sign and date a written informed consent prior to entering the study.
- Patients must be willing and able to comply with the protocol requirements for the duration of the study.
- Patients with history of any multiple sclerosis (MS) exacerbations or relapses, including any episodes of optic neuritis.
- Progressive neurological disorder other than PPMS.
- Any MRI record showing presence of cervical cord compression.
- Baseline MRI showing other findings (including lesions that are atypical for PPMS) that may explain the clinical signs and symptoms.
- Relevant history of vitamin B12 deficiency.
- Positive human T-lymphotropic virus Type I and II (HTLV-I/II) serology.
- Use of experimental or investigational drugs in a clinical study within 24 weeks prior to baseline. Use of a currently marketed drug in a clinical study within 24 weeks prior to baseline would not be exclusionary, provided no other exclusion criteria are met.
- Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azathioprine within 48 weeks prior to baseline.
- Previous treatment with fingolimod (GILENYA®, Novartis), dimethyl fumarate (TECFIDERA®, Biogen Idec Inc), glatiramer acetate (COPAXONE®, Teva), interferon-β (either 1a or 1b), intravenous immunoglobulin, or plasmapheresis within 8 weeks prior to baseline.
- Use of teriflunomide (AUBAGIO®, Sanofi) within 2 years prior to baseline, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to baseline.
- Prior use of monoclonal antibodies ever, except for:
- natalizumab (TYSABRI®, Biogen Idec Inc), if given more than 24 weeks prior to baseline AND the patient is John Cunningham (JC) virus antibody test negative (as per medical history)
- rituximab, ocrelizumab, or ofatumumab, if B cell count (CD19, as per medical history) is higher than 80 cells/μL
- Use of mitoxantrone (NOVANTRONE®, Immunex) within 5 years prior to screening. Use of mitoxantrone >5 years before screening is allowed in patients with normal ejection fraction and who did not exceed the total lifetime maximal dose.
- Previous use of laquinimod.
- Chronic (eg, more than 30 consecutive days or monthly dosing, with the intent of MS disease modification) systemic (intravenous, intramuscular or oral) corticosteroid treatment within 8 weeks prior to baseline.
- Previous use of cladribine or alemtuzumab (LEMTRADA®, Sanofi).
- Previous total body irradiation or total lymphoid irradiation.
- Previous stem cell treatment, cell-based treatment, or bone marrow transplantation of any kind.
- Patients who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) within 12 weeks prior to baseline.
- Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to baseline.
- Use of inducers of CYP3A4 within 2 weeks prior to baseline.
- Pregnancy or breastfeeding.
- Serum levels ≥3× upper limit of the normal range (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at screening.
- Serum direct bilirubin which is ≥2×ULN at screening.
- Patients with a clinically significant or unstable medical or surgical condition that (in the opinion of the Investigator) would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests or chest X-ray.
- A known history of hypersensitivity to gadolinium (Gd).
- Glomerular filtration rate (GFR) < or equal 60 mL/min at screening visit.
- Inability to successfully undergo MRI scanning, including claustrophobia.
- Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to mannitol, meglumine or sodium stearyl fumarate.
|Official title||A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) Phase 2|
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