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Multiple SclerosisPhase 3ALLEGRONCT00509145

Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)

A Phase 3 study testing Laquinimod in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 144 sites in 24 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

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
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
1,106 participants
Where
144 sitesin 24 countries
Study dates
13 Nov 2007to 8 Nov 2010
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course.
  • Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.5.
  • Subjects must be in a stable neurological condition and free of corticosteroid treatment [intravenous (iv), intramuscular (im) and/or per os (po)] 30 days prior to screening (month -1).
  • Subjects must have had experienced one of the following:
  • At least one documented relapse in the 12 months prior to screening
  • At least two documented relapses in the 24 months prior to screening
Show all 12Show fewer
  • One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
  • Subjects must be between 18 and 55 years of age, inclusive.
  • Subjects must have disease duration of at least 6 months (from the first symptom) prior to screening.
  • Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide).
  • Subjects must be able to sign and date a written informed consent prior to entering the study
  • Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Who cannot join

  • Subjects with progressive forms of MS
  • An onset of relapse, unstable neurological condition or any treatment with corticosteroids [intravenous (iv), intramuscular (im) and/or per os (po)] or ACTH between month -1 (screening) and 0 (baseline).
  • Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
  • Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
  • Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod.
  • Previous treatment with glatiramer acetate (Copaxone®) Interferon-β (either 1a or 1b) or IVIG within 2 months prior to screening visit.
Show all 37Show fewer
  • Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
  • Previous total body irradiation or total lymphoid irradiation.
  • Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  • A known history of tuberculosis.
  • Acute infection two weeks prior to baseline visit.
  • Major trauma or surgery two weeks prior to baseline
  • A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis).
  • A carrier state of factor V Leiden mutation (either homo- or heterozygous) as disclosed at screening.
  • Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit.
  • Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine) see detailed list in Appendix 5
  • Use of amiodarone within 2 years prior to screening visit.
  • Pregnancy or breastfeeding.
  • Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:
  • A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
  • A gastrointestinal disorder that may affect the absorption of study medication.
  • Renal or metabolic diseases.
  • Any form of chronic liver disease, including known non-alcoholic steatohepatitis.
  • A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin
  • A QTC interval (obtained from either 2 ECG recordings at screening or from the mean value calculated from 3 measurements at baseline visit) which is >450msec.
  • A family history of Long- QT syndrome.
  • A history of drug and/or alcohol abuse.
  • Major psychiatric disorder.
  • A known history of sensitivity to Gd.
  • Inability to successfully undergo MRI scanning.
  • Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
  • Subjects who suffer from any form of progressive MS.
  • Any condition which the investigator feels may interfere with participation in the study.
  • Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation,
  • Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
  • Previous treatment with immunomodulators within two months prior to screening
  • Pregnancy or breastfeeding.

Trial locations and contacts

144 sites in 24 countries.

144 sites in 24 countries

United States23 sites

  • Teva Investigational Site 1090

    Centennial, Colorado, 80112

  • Teva Investigational Site 1084

    Dayton, Ohio, 45417

  • Teva Investigational Site 1083

    Des Moines, Iowa, 50314

  • Teva Investigational Site 1097

    Fargo, North Dakota, 58103

  • Teva Investigational Site 1096

    Farmington Hills, Michigan, 48334

  • Teva Investigational Site 1088

    Fort Collins, Colorado, 80528

  • Teva Investigational Site 1081

    Fort Wayne, Indiana, 46805

  • Teva Investigational Site 1100

    Hershey, Pennsylvania, 17033-0850

  • Teva Investigational Site 1086

    Kansas City, Kansas, 66160

  • Teva Investigational Site 1101

    Lexington, Kentucky, 40513

  • Teva Investigational Site 1075

    Lubbock, Texas, 79410

  • Teva Investigational Site 1085

    Milwaukee, Wisconsin, 53215

  • Teva Investigational Site 1093

    Minneapolis, Minnesota, 55414

  • Teva Investigational Site 1094

    New Haven, Connecticut, 06520-8018

  • Teva Investigational Site 1082

    New York, New York, 10003

  • Teva Investigational Site 1102

    Northbrook, Illinois, 60062

  • Teva Investigational Site 1092

    Oklahoma City, Oklahoma, 73120

  • Teva Investigational Site 1087

    Philadelphia, Pennsylvania, 19104

  • Teva Investigational Site 1076

    Phoenix, Arizona, 85004

  • Teva Investigational Site 1079

    Rochester, New York, 14642

  • Teva Investigational Site 1078

    San Antonio, Texas, 78231

  • Teva Investigational Site 1098

    St Louis, Missouri, 63104

  • Teva Investigational Site 1073

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany16 sites

  • Teva Investigational Site 3247

    Bayreuth, 95445

  • Teva Investigational Site 3241

    Berlin, 10713

  • Teva Investigational Site 3238

    Berlin, 13347

  • Teva Investigational Site 3248

    Bochum, 44791

  • Teva Investigational Site 3245

    Dresden, 01307

  • Teva Investigational Site 3237

    Emden, 26721

  • Teva Investigational Site 3242

    Erbach im Odenwald, 64711

  • Teva Investigational Site 3240

    Erfurt, 99089

  • Teva Investigational Site 3249

    Freiburg im Breisgau, 79106

  • Teva Investigational Site 3236

    Hamburg, 20246

  • Teva Investigational Site 3246

    Hamburg, 22417

  • Teva Investigational Site 3239

    Hanover, 30559

  • Teva Investigational Site 3243

    Heidelberg, 69120

  • Teva Investigational Site 3251

    Münster, 48149

  • Teva Investigational Site 3250

    Trier, 54292

  • Teva Investigational Site 3244

    Ulm, 89081

Other trials in Germany

Spain13 sites

  • Teva Investigational Site 3132

    Barcelona, 08035

  • Teva Investigational Site 3134

    Barcelona, 08036

  • Teva Investigational Site 3144

    Barcelona, 08041

  • Teva Investigational Site 3140

    Beade-Vigo, 36312

  • Teva Investigational Site 3142

    Getafe, 28905

  • Teva Investigational Site 3136

    Girona, 17007

  • Teva Investigational Site 3135

    Lleida, 25198

  • Teva Investigational Site 3133

    Madrid, 28040

  • Teva Investigational Site 3146

    Madrid, 28046

  • Teva Investigational Site 3137

    Murcia, 30120

  • Teva Investigational Site 3138

    Pontevedra, 36001

  • Teva Investigational Site 3139

    Santiago de Compostela, 15706

  • Teva Investigational Site 3143

    Valencia, 46010

Other trials in Spain

Russia11 sites

  • Teva Investigational Site 5031

    Kemerovo, 650066

  • Teva Investigational Site 5021

    Moscow, 127018

  • Teva Investigational Site 5028

    Nizhny Novgorod, 603126

  • Teva Investigational Site 5027

    Novosibirsk, 630087

  • Teva Investigational Site 5030

    Perm, 614990

  • Teva Investigational Site 5026

    Saint Petersburg, 191025

  • Teva Investigational Site 5025

    Saint Petersburg, 194044

  • Teva Investigational Site 5024

    Saint Petersburg, 194354

  • Teva Investigational Site 5022

    Saint Petersburg, 197022

  • Teva Investigational Site 5023

    Saint Petersburg, 197376

  • Teva Investigational Site 5029

    Yekaterinburg, 620102

Other trials in Russia

Italy10 sites

  • Teva Investigational Site 3044

    Catania, 95122

  • Teva Investigational Site 3045

    Fidenza, 43036

  • Teva Investigational Site 3042

    Gallarate, 21013

  • Teva Investigational Site 3046

    Grosseto, 58100

  • Teva Investigational Site 3047

    Milan, 20122

  • Teva Investigational Site 3038

    Milan, 20132

  • Teva Investigational Site 555

    Milan, 20132

  • Teva Investigational Site 3039

    Milan, 20148

  • Teva Investigational Site 3041

    Palermo, 90146

  • Teva Investigational Site 3040

    Rome, 00133

Other trials in Italy

Poland8 sites

  • Teva Investigational Site 5322

    Częstochowa, 42-200

  • Teva Investigational Site 5319

    Gmina Końskie, 26-200

  • Teva Investigational Site 5320

    Gorzów Wielkopolski, 66-400

  • Teva Investigational Site 5316

    Katowice, 40-752

  • Teva Investigational Site 5318

    Kielce, 25-736

  • Teva Investigational Site 5317

    Krakow, 31-826

  • Teva Investigational Site 5315

    Lodz, 90-153

  • Teva Investigational Site 5325

    Warsaw, 04-749

Other trials in Poland

Canada7 sites

  • Teva Investigational Site 1130

    Greenfield Park, Quebec, J4V 2J2

  • Teva Investigational Site 1132

    Halifax, Nova Scotia, B3M 0A6

  • Teva Investigational Site 1126

    London, Ontario, N6A 5A5

  • Teva Investigational Site 1129

    Montreal, Quebec, H1T 2M4

  • Teva Investigational Site 1128

    Ottawa, Ontario, K2G 6E2

  • Teva Investigational Site 1131

    Sherbrooke, Quebec, J1H 5N4

  • Teva Investigational Site 1134

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Bulgaria6 sites

  • Teva Investigational Site 5901

    Pleven, 5800

  • Teva Investigational Site 5904

    Sofia, 1113

  • Teva Investigational Site 5903

    Sofia, 1309

  • Teva Investigational Site 5900

    Sofia, 1606

  • Teva Investigational Site 5905

    Sofia, 1606

  • Teva Investigational Site 5902

    Varna, 9010

Other trials in Bulgaria

France6 sites

  • Teva Investigational Site 3525

    Besançon, 25030

  • Teva Investigational Site 3527

    Bron, 69677

  • Teva Investigational Site 3526

    Clermont-Ferrand, 63003

  • Teva Investigational Site 3524

    Lille, 59037

  • Teva Investigational Site 3528

    Marseille, 13385

  • Teva Investigational Site 3529

    Rennes, 35033

Other trials in France

Israel5 sites

  • Teva Investigational Site 8034

    Haifa, 31048

  • Teva Investigational Site 8031

    Haifa, 3436212

  • Teva Investigational Site 8030

    Jerusalem, 9112001

  • Teva Investigational Site 8033

    Ramat Gan, 5262160

  • Teva Investigational Site 8032

    Tel Aviv, 78278

Other trials in Israel

Romania5 sites

  • Teva Investigational Site 5208

    Bucharest, 011461

  • Teva Investigational Site 5210

    Cluj-Napoca, 400437

  • Teva Investigational Site 5212

    Constanța, 900123

  • Teva Investigational Site 5211

    Târgu Mureş, 540136

  • Teva Investigational Site 5209

    Timișoara, 300736

Other trials in Romania

Ukraine5 sites

  • Teva Investigational Site 5803

    Dnipropetrovsk, 49027

  • Teva Investigational Site 5802

    Kyiv, 03110

  • Teva Investigational Site 5804

    Kyiv, 03115

  • Teva Investigational Site 5800

    Lviv, 79010

  • Teva Investigational Site 5801

    Vinnytsia, 21005

Other trials in Ukraine

Austria4 sites

  • Teva Investigational Site 3300

    Klagenfurt, 9020

  • Teva Investigational Site 3303

    Linz, A-4021

  • Teva Investigational Site 3302

    Sankt Pölten, 3100

  • Teva Investigational Site 3301

    Villach, 9500

Other trials in Austria

Hungary4 sites

  • Teva Investigational Site 5115

    Budapest, H-1145

  • Teva Investigational Site 5114

    Debrecen, 4043

  • Teva Investigational Site 5116

    Miskolc, 3526

  • Teva Investigational Site 5117

    Veszprém, H-8200

Other trials in Hungary

Netherlands3 sites

  • Teva Investigational Site 3809

    Groesbeek, 6561 KE

  • Teva Investigational Site 3810

    Nieuwegein, 3430 EM

  • Teva Investigational Site 3811

    Tilburg, 5022 GC

Other trials in Netherlands

Sweden3 sites

  • Teva Investigational Site 4204

    Stockholm, 14186

  • Teva Investigational Site 4205

    Stockholm, 17176

  • Teva Investigational Site 4206

    Stockholm, 18288

Other trials in Sweden

United Kingdom3 sites

  • Teva Investigational Site 3425

    Liverpool, L9 7LJ

  • Teva Investigational Site 3424

    London, E1 2AT

  • Teva Investigational Site 3422

    Sheffield, S10 2JF

Other trials in United Kingdom

Czechia2 sites

  • Teva Investigational Site 5417

    Olomouc, 779 00

  • Teva Investigational Site 5416

    Ostrava - Poruba, 708 52

Other trials in Czechia

Estonia2 sites

  • Teva Investigational Site 5504

    Tallinn, EE-10617

  • Teva Investigational Site 5505

    Tartu, EE-51014

Other trials in Estonia

Georgia2 sites

  • Teva Investigational Site 8100

    Tbilisi, 0112

  • Teva Investigational Site 8101

    Tbilisi, 0179

Other trials in Georgia

Lithuania2 sites

  • Teva Investigational Site 5704

    Kaunas, 50009

  • Teva Investigational Site 5705

    Šiauliai, 76231

Other trials in Lithuania

Serbia2 sites

  • Teva Investigational Site 6100

    Belgrade, 11000

  • Teva Investigational Site 6102

    Niš, 18 000

Other trials in Serbia

Latvia1 site

  • Teva Investigational Site 5604

    Riga, 1015

Other trials in Latvia

Turkey (Türkiye)1 site

  • Teva Investigational Site 8201

    Izmir, 35340

Other trials in Turkey (Türkiye)

About this study

Official title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS

Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

Being tested
Laquinimod, Placebo
Keywords
Relapsing, Remitting
Medical subject headings
Multiple Sclerosis, Recurrence

What participants receive

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

  • LaquinimodDrug

    Also called TV-5600

    Laquinimod 0.6 mg capsule, oral, once daily

  • PlaceboOther

    oral, once daily, capsule

Study groups in NCT00509145
Study groupRoleWhat they receive
LaquinimodExperimentalLaquinimod 0.6 mg, oral
Receives: Drug: Laquinimod
PlaceboPlacebo comparatorMatching placebo
Receives: Other: Placebo

What is being measured

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

  1. Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period

    A relapse was defined as the appearance of at least one new neurological abnormality or the reappearance of at least one previously observed neurological abnormalities lasting greater than or equal to 48 hours and immediately preceded by an improving neurological state of greater than or equal to 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with one or more of the following: An increase of greater than or equal to 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation, an increase of one grade in the actual score of greater than or equal to 2 of the 7 functional systems (FS), as compared to previous evaluation, or an increase of 2 grades in the actual score of one FS as compared to the previous evaluation.

    Measured: Up to Month 24

Secondary outcomes (4)

  1. Composite Endpoint: Sum of the Number of T1 Gadolinium (Gd)-Enhanced Lesions on T1-Weighted MRI Images

    Composite score was calculated as the sum of the number of gadolinium (Gd)-enhanced lesions at Month 12 and the number of gadolinium (Gd)-enhanced lesions at Month 24 on T1-Weighted MRI scans.

    Measured: Month 12, Month 24

  2. Composite Endpoint: Sum of the Number of New/Enlarging T2 Lesions

    Composite score calculated as the sum of T2 lesions at Months 12 and 24 that are new or enlarged.

    Measured: Month 12, Month 24

  3. Accumulation of Physical Disability Measured by the Time to Confirmed Progression of Expanded Disability Status Scale (EDSS)

    EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). A confirmed progression of EDSS is defined as at least 1 point increase from baseline if baseline EDSS was between 0 and 5.0, or at least 0.5 point increase if baseline EDSS was 5.5 or higher, confirmed 3 months later. Participants were assessed between baseline and month 24 visit. Participants that met these criteria for any 3 consecutive months were counted in the progression category. Progression could not be confirmed during an MS relapse. Data is presented as a distribution of confirmed disease progression (CDP) events (number of participants with CDP).

    Measured: Baseline to Month 24

  4. Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score

    The Multiple Sclerosis Functional Composite is an instrument assessing disability that consists of 3 clinical assessments. The 3 are Timed 25-Foot Walk, 9-Hole Peg Test which measures upper extremity (arm and hand) function, and PASAT (Paced Auditory Serial Addition Test) which is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. A Z-score is used to define a common metric from the 3 assessments that constitute the MSFC score. The study's population at baseline was used as reference population for the Z-score calculation. A Z-score of 0 represents the population mean at baseline. Higher Z-scores correspond to an improved outcome.

    Measured: Baseline, Month 24

Timeline

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

  1. First posted31 Jul 2007 (estimated)
  2. Study start13 Nov 2007
  3. Primary completion8 Nov 2010
  4. Study completion8 Nov 2010

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
1,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00509145
Sponsor's protocol ID
MS-LAQ-301
Other IDs
EUDRACT 2007-003226-19
Acronym
ALLEGRO
Status last verified
Sep 2021
First submitted
27 Jul 2007
Last updated
2 Nov 2021
Data monitoring committee
Yes

Publications

  • Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun.

    PubMed 26000222

  • Filippi M, Rocca MA, Pagani E, De Stefano N, Jeffery D, Kappos L, Montalban X, Boyko AN, Comi G; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):851-8. doi: 10.1136/jnnp-2013-306132. Epub 2013 Sep 12.

    PubMed 24029546

  • Comi G, Jeffery D, Kappos L, Montalban X, Boyko A, Rocca MA, Filippi M; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med. 2012 Mar 15;366(11):1000-9. doi: 10.1056/NEJMoa1104318.

    PubMed 22417253

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laquinimod in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 144 sites in 24 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 12 inclusion and 37 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Germany, Spain, Russia, Italy and 19 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 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 2 Nov 2021). 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?

Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (time frame: Up to Month 24). 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 NCT00509145, which also lists 3 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 2 Nov 2021.

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