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Primary Progressive Multiple SclerosisPhase 2ARPEGGIONCT02284568

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

A Phase 2 study testing Laquinimod in people with Primary Progressive Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 99 sites in 10 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 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. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Primary Progressive Multiple Sclerosis
What is being tested?
Laquinimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
99 sitesin 10 countries
Study dates
12 Jan 2015to 1 Oct 2017
Phase
Phase 2
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 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.

Trial locations and contacts

99 sites in 10 countries.

99 sites in 10 countries

United States15 sites

  • Teva Investigational Site 12964

    Aurora, Colorado, 80045

  • Teva Investigational Site 12971

    Charlotte, North Carolina, 28207

  • Teva Investigational Site 12965

    Chesterfield, Missouri, 63017

  • Teva Investigational Site 12976

    Columbus, Ohio, 43221

  • Teva Investigational Site 12977

    Golden Valley, Minnesota, 55422

  • Teva Investigational Site 13010

    Golden Valley, Minnesota, 55422

  • Teva Investigational Site 12975

    Kansas City, Kansas, 66160-7314

  • Teva Investigational Site 12969

    Lenexa, Kansas, 66214

  • Teva Investigational Site 12963

    New York, New York, 10016

  • Teva Investigational Site 12967

    Newport Beach, California, 92663

  • Teva Investigational Site 12973

    Northbrook, Illinois, 60062

  • Teva Investigational Site 12966

    Phoenix, Arizona, 85018

  • Teva Investigational Site 12962

    San Francisco, California, 94158

  • Teva Investigational Site 12968

    St Louis, Missouri, 63110

  • Teva Investigational Site 12970

    Uniontown, Ohio, 44685

Other trials in United States

Germany15 sites

  • Teva Investigational Site 32505

    Bad Mergentheim, 97980

  • Teva Investigational Site 32512

    Bamberg, 96049

  • Teva Investigational Site 32510

    Berlin, 10117

  • Teva Investigational Site 32522

    Bochum, 44791

  • Teva Investigational Site 32509

    Dresden, 01307

  • Teva Investigational Site 32517

    Düsseldorf, 40225

  • Teva Investigational Site 32543

    Goettigen, 37075

  • Teva Investigational Site 32514

    Hamburg, 20099

  • Teva Investigational Site 32507

    Hanover, 30625

  • Teva Investigational Site 32513

    München, 81675

  • Teva Investigational Site 32504

    München, D-81377

  • Teva Investigational Site 32516

    Rostock, 18057

  • Teva Investigational Site 32523

    Trier, 54292

  • Teva Investigational Site 32503

    Ulm, 89081

  • Teva Investigational Site 32511

    Würzburg, 97080

Other trials in Germany

Russia11 sites

  • Teva Investigational Site 50285

    Kaluga, 248007

  • Teva Investigational Site 50288

    Kazan', 420021

  • Teva Investigational Site 50290

    Kazan', 420103

  • Teva Investigational Site 50294

    Kirov, 610006

  • Teva Investigational Site 50292

    Krasnoyarsk, 660022

  • Teva Investigational Site 50287

    Moscow, 127018

  • Teva Investigational Site 50291

    Nizhny Novgorod, 603126

  • Teva Investigational Site 50286

    Novosibirsk, 630007

  • Teva Investigational Site 50295

    Perm, 614990

  • Teva Investigational Site 50289

    Saint Petersburg, 194044

  • Teva Investigational Site 50293

    Saint Petersburg, 197022

Other trials in Russia

Poland10 sites

  • Teva Investigational Site 53262

    Bialystok, 15-402

  • Teva Investigational Site 53250

    Bydgoszcz, 85-795

  • Teva Investigational Site 53253

    Gdansk, 80-803

  • Teva Investigational Site 53257

    Katowice, 40-635

  • Teva Investigational Site 53258

    Katowice, 40-684

  • Teva Investigational Site 53256

    Katowice, 40-749

  • Teva Investigational Site 53255

    Kielce, 25-726

  • Teva Investigational Site 53260

    Lublin, 20-954

  • Teva Investigational Site 53261

    Olsztyn, 10-560

  • Teva Investigational Site 53252

    Warsaw, 02-957

Other trials in Poland

Spain10 sites

  • Teva Investigational Site 31108

    Barcelona, 08036

  • Teva Investigational Site 31106

    Barcelona, 8035

  • Teva Investigational Site 31104

    Donostia / San Sebastian, 20014

  • Teva Investigational Site 31105

    El Palmar, 30120

  • Teva Investigational Site 31111

    Lleida, 25198

  • Teva Investigational Site 31112

    Madrid, 28040

  • Teva Investigational Site 31192

    Madrid, 28223

  • Teva Investigational Site 31101

    Málaga, 29010

  • Teva Investigational Site 31102

    Seville, 41009

  • Teva Investigational Site 31100

    Valencia, 46026

Other trials in Spain

Ukraine10 sites

  • Teva Investigational Site 58158

    Dnipropetrovsk, 49005

  • Teva Investigational Site 58159

    Ivano-Frankivsk, 76014

  • Teva Investigational Site 58157

    Kharkiv, 61068

  • Teva Investigational Site 58160

    Kyiv, ?03110

  • Teva Investigational Site 58152

    Lutsk, 43005

  • Teva Investigational Site 58154

    Lviv, 79010

  • Teva Investigational Site 58153

    Lviv, 79044

  • Teva Investigational Site 58150

    Zaporizhzhya, 69035

  • Teva Investigational Site 58156

    Zaporizhzhya, 69068

  • Teva Investigational Site 58151

    Zaporizhzhya, 69600

Other trials in Ukraine

United Kingdom10 sites

  • Teva Investigational Site 34190

    Bristol, BS10 5NB

  • Teva Investigational Site 34188

    Edinburgh, EH4 2XU

  • Teva Investigational Site 34189

    Exeter, EX2 5DW

  • Teva Investigational Site 34182

    Liverpool, L9 7LJ

  • Teva Investigational Site 34181

    London, E1 2AT

  • Teva Investigational Site 34183

    Nottingham, NG7 2UH

  • Teva Investigational Site 34184

    Oxford, OX3 9DU

  • Teva Investigational Site 34186

    Plymouth, PL6 8DH

  • Teva Investigational Site 34185

    Stoke-on-Trent, ST4 6GQ

  • Teva Investigational Site 34187

    Swansea, SA6 6NL

Other trials in United Kingdom

Italy9 sites

  • Teva Investigational Site 30106

    Cefalù, 90015

  • Teva Investigational Site 30110

    Florence, 50134

  • Teva Investigational Site 30105

    Gallarate, 21013

  • Teva Investigational Site 30108

    Genova, 16132

  • Teva Investigational Site 30102

    Milan, 20127

  • Teva Investigational Site 30107

    Orbassano, 10043

  • Teva Investigational Site 30103

    Padova, 35128

  • Teva Investigational Site 30101

    Rome, 00133

  • Teva Investigational Site 30104

    Rome, ?00152

Other trials in Italy

Canada6 sites

  • Teva Investigational Site 11089

    Calgary, AL, T2N 4Z1

  • Teva Investigational Site 11084

    Halifax, Nova Scotia, B3H 4K4

  • Teva Investigational Site 11082

    Montreal, Quebec, H3A 2B4

  • Teva Investigational Site 11081

    Ottawa, Ontario, K1H 8L6

  • Teva Investigational Site 11088

    Québec, Quebec, G1J 1Z4

  • Teva Investigational Site 11087

    Toronto, Ontario, M5B-1W8

Other trials in Canada

Netherlands3 sites

  • Teva Investigational Site 38068

    Amsterdam, 1081 HV

  • Teva Investigational Site 38067

    Nijmegen, 6532 SZ

  • Teva Investigational Site 38069

    Sittard, 6162 BG

Other trials in Netherlands

About this study

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)

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.

Read the detailed description

Due to serious cardiovascular adverse events, Data Monitoring Committee (DMC) made a recommendation to stop all laquinimod treatment arms above 0.6 mg in the multiple sclerosis (MS) trials; therefore the 1.5 mg treatment arm in the ARPEGGIO study was discontinued as of 01 January 2016.

The DMC did not identify any definite cardiovascular risk in the 0.6 mg treatment arm, but felt that long term monitoring for emergence of any potential signal was necessary. Therefore, the 0.6 mg treatment arm was continued while the sponsor closely monitored cardiovascular events in all laquinimod studies. Prior to 01 January 2016, eligible patients were randomized in a 1:1:1 ratio into 1 of the following treatment arms (a total of 286 patients were randomized 1:1:1 prior to

01 January 2016):

  • Laquinimod 0.6 mg daily
  • Laquinimod 1.5 mg daily
  • Daily placebo

As of 01 January 2016, following the decision to discontinue the laquinimod 1.5 mg dose arm, additional eligible patients (87 patients) who were enrolled were randomized in a 1:1 ratio into one of the following treatment arms:

  • Laquinimod 0.6 mg daily
  • Daily placebo
Being tested
Placebo, Laquinimod
Keywords
multiple sclerosis, primary progressive multiple sclerosis, oral immunomodulator
Medical subject headings
Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis

What participants receive

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

  • PlaceboDrug

    Placebo

  • LaquinimodDrug

    Also called TV-5600

    Laquinimod capsules in 0.5 mg and 0.6 mg strengths

  • PlaceboDrug

    Placebo capsules

Study groups in NCT02284568
Study groupRoleWhat they receive
PlaceboPlacebo comparatoronce daily oral dose
Receives: Drug: Placebo
Laquinimod 0.6 mgExperimental1 capsule containing 0.6 mg laquinimod and 2 capsules containing placebo were administered orally once daily for at least 48 weeks.
Receives: Drug: Laquinimod; Drug: Placebo
Laquinimod 1.5 mgExperimental3 capsules containing 0.5 mg laquinimod were administered orally once daily for at least 48 weeks. However this arm was discontinued as of 01 January 2016 and no participants reached the 48 week timeframe.
Receives: Drug: Laquinimod

What is being measured

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

  1. Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model

    Brain atrophy (BA) was measured using magnetic resonance imaging (MRI) scans of the brain. BA was analyzed using baseline-adjusted repeated measures analysis of covariance (ANCOVA- SAS® PROC MIXED) in which 1 contrast was constructed in order to compare between laquinimod 0.6 mg and placebo. The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects. Only on-treatment observations (include all the assessments done up to one month after the last dose of the study drug) were included. Values are adjusted means. The cancelled laquinimod 1.5 mg treatment arm was not included in the repeated measures ANCOVA model analysis. However PBVC by visit data are offered in outcome #2.

    Measured: Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits

  2. Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48

    Brain atrophy (BA) was measured using magnetic resonance imaging (MRI) scans of the brain. Early termination scans of participants who discontinued the study after week 36 are considered scans at week 48.

    Measured: Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48

Secondary outcomes (5)

  1. Percentage of Participants With 12-Week Confirmed Disability Progression (CDP) As Measured by Expanded Disability Status Scale (EDSS) up to Week 48

    CDP was defined as increase in EDSS of >=1 point from baseline EDSS, if EDSS at entry is ≤5.0 or increase of >=0.5 point, if EDSS at entry is >=5.5. This increase should be confirmed after at least 12 weeks. Progression cannot be confirmed during a protocol defined relapse. EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments with 0=no disability and 10=death due to MS. Only an Examining Neurologist administered the EDSS. The Examining Neurologist did not have access to the patient's medical records or source documents, including previous EDSS forms or adverse events. If a patient died due to MS disease progression, the patient was analyzed as having CDP with the time to CDP as the onset date of progression. If a patient died due to MS before having progression, then the time to disability progression was censored using the date of death.

    Measured: Baseline (Week 0), Weeks 12, 24, 36, 48 (end if treatment if < 48 weeks)

  2. Percentage of Participants With 12-Week Confirmed Disability Progression (CDP) As Measured by Expanded Disability Status Scale (EDSS) or the Timed 25-foot Walk (T25FW) Test up to Week 48

    CDP was defined as

    increase in EDSS of >=1 point from baseline EDSS, if EDSS at entry is ≤5.0 or increase of >=0.5 point, if EDSS at entry is >=5.5 confirmed after at least 12 weeks, OR increase of >= 20% from baseline in the T25FW test, confirmed after at least 12 weeks.

    EDSS quantifies disability in MS and monitors changes in the level of disability over time. The EDSS scale is 0-10 in 0.5 unit increments with 0=no disability and 10=death due to MS. The T25-FW is a quantitative mobility and leg function performance test based on the average time of two trials in which participants walk 25 feet as quickly as possible. Increasing time scores indicate increasing impairment.

    If a patient died due to MS disease progression, the patient was analyzed as having CDP with the time to CDP as the onset date of progression. If a patient died due to MS before having progression, then the time to disability progression was censored using the date of death.

    Measured: Baseline (Week 0), Weeks 12, 24, 36, 48 (end if treatment if < 48 weeks)

  3. Change From Baseline for the Timed 25-foot Walk (T25FW) Score at Weeks 12, 24, 36 and 48

    The T25FW is a quantitative mobility and leg function performance test based on the average time of two trials in which participants walk 25 feet as quickly as possible. In cases when a patient could not complete a T25FW trial due to the physical limitations, a value of 180 seconds was assigned for that trial (this is the maximal possible value for the T25FW test). Increasing time scores indicate increasing impairment. Baseline values are summaries of observed values. Week values are change from baseline values.

    Measured: Baseline (Week 0), Weeks 12, 24, 36, 48

  4. Number of New T2 Brain Lesions at Week 48

    Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new T2 lesions at week 48 as compared to baseline. Scans of patients who discontinued the study after week 36 are considered scans at week 48, and are included in week 48.

    Measured: Baseline (Week 0), 48 weeks

  5. Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: Day 1 up to Week 130 (longest duration of treatment)

Timeline

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

  1. First posted6 Nov 2014 (estimated)
  2. Study start12 Jan 2015
  3. Primary completion4 May 2017
  4. Study completion1 Oct 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02284568
Sponsor's protocol ID
TV5600-CNS-20006
Other IDs
2014-001579-30, 2014
Acronym
ARPEGGIO
Status last verified
Mar 2022
First submitted
31 Oct 2014
Last updated
10 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Falet JR, Durso-Finley J, Nichyporuk B, Schroeter J, Bovis F, Sormani MP, Precup D, Arbel T, Arnold DL. Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning. Nat Commun. 2022 Sep 26;13(1):5645. doi: 10.1038/s41467-022-33269-x.

    PubMed 36163349

  • Giovannoni G, Knappertz V, Steinerman JR, Tansy AP, Li T, Krieger S, Uccelli A, Uitdehaag BMJ, Montalban X, Hartung HP, Pia Sormani M, Cree BAC, Lublin F, Barkhof F. A randomized, placebo-controlled, phase 2 trial of laquinimod in primary progressive multiple sclerosis. Neurology. 2020 Aug 25;95(8):e1027-e1040. doi: 10.1212/WNL.0000000000010284. Epub 2020 Jul 10.

    PubMed 32651286

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laquinimod in people with Primary Progressive Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 99 sites in 10 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 9 inclusion and 30 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Germany, Russia, Poland, Spain and 5 more countries. 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?

Yes. Results are posted in the registry (first posted 2 Nov 2018). 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?

Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model (time frame: Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits). The study lists 2 primary outcomes in all. 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 NCT02284568, which also lists 2 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 Mar 2022.

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