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Tardive DyskinesiaPhase 3RIM-TDNCT02198794

Reducing Involuntary Movements in Participants With Tardive Dyskinesia

A Phase 3 study testing SD-809 in people with Tardive Dyskinesia, run by Auspex Pharmaceuticals, Inc. at 82 sites in 6 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 long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tardive Dyskinesia
What is being tested?
SD-809
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
343 participants
Where
82 sitesin 6 countries
Study dates
20 Oct 2014to 14 Dec 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of using a dopamine receptor antagonist for at least 3 months
  • Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
  • Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia
  • Participants with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
  • Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
  • History of being compliant with prescribed medications
Show all 9Show fewer
  • Able to swallow study drug whole
  • Be in good general health and is expected to attend all study visits and complete study assessments
  • Female participants must not be pregnant and agree to an acceptable method of contraception

Who cannot join

  • Currently receiving medication for the treatment of tardive dyskinesia
  • Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
  • Have a serious untreated or undertreated psychiatric illness
  • Have recent history or presence of violent behavior
  • Have unstable or serious medical illness
  • Have evidence of hepatic impairment
Show all 11Show fewer
  • Have evidence of renal impairment
  • Have known allergy to any component of SD-809 or tetrabenazine
  • Has participated in an investigational drug or device trial (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) and received study drug within 30 days
  • Have acknowledged use of illicit drugs
  • Have a history of alcohol or substance abuse in the previous 12 months

Trial locations and contacts

82 sites in 6 countries.

82 sites in 6 countries

United States44 sites

  • Teva Investigational Site 128

    Albuquerque, New Mexico, 87106

  • Teva Investigational Site 107

    Anaheim, California, 92804

  • Teva Investigational Site 108

    Anaheim, California, 92805

  • Teva Investigational Site 155

    Augusta, Georgia, 30912

  • Teva Investigational Site 154

    Baltimore, Maryland, 21287

  • Teva Investigational Site 157

    Boca Raton, Florida, 33486

  • Teva Investigational Site 133

    Charleston, South Carolina, 29425

  • Teva Investigational Site 131

    Chicago, Illinois, 60611

  • Teva Investigational Site 118

    Creve Coeur, Missouri, 63141

  • Teva Investigational Site 165

    Decatur, Georgia, 30033

  • Teva Investigational Site 129

    Englewood, Colorado, 80113

  • Teva Investigational Site 151

    Fort Worth, Texas, 76104

  • Teva Investigational Site 117

    Gainesville, Florida, 32607

  • Teva Investigational Site 114

    Garfield Heights, Ohio, 44125

  • Teva Investigational Site 101

    Glen Burnie, Maryland, 21061

  • Teva Investigational Site 123

    Glendale, California, 91206

  • Teva Investigational Site 160

    Irvine, California, 92614

  • Teva Investigational Site 142

    Kansas City, Missouri, 64108

  • Teva Investigational Site 150

    Lake City, Florida, 32025

  • Teva Investigational Site 178

    Lincoln, Nebraska, 68526-9467

  • Teva Investigational Site 176

    Loma Linda, California, 92354

  • Teva Investigational Site 121

    Los Angeles, California, 90033

  • Teva Investigational Site 147

    Los Angeles, California, 90095-1769

  • Teva Investigational Site 149

    Memphis, Tennessee, 38163

  • Teva Investigational Site 153

    Miami, Florida, 33135

  • Teva Investigational Site 162

    Miami, Florida, 33165

  • Teva Investigational Site 139

    New Haven, Connecticut, 06519

  • Teva Investigational Site 174

    Norwalk, California, 90650

  • Teva Investigational Site 130

    Oceanside, California, 92056

  • Teva Investigational Site 102

    Orange, California, 92868

  • Teva Investigational Site 112

    Orlando, Florida, 32803

  • Teva Investigational Site 144

    Port Charlotte, Florida, 33980

  • Teva Investigational Site 146

    Raleigh, North Carolina, 27610

  • Teva Investigational Site 167

    Richland, Washington, 99352

  • Teva Investigational Site 115

    Salt Lake City, Utah, 84105

  • Teva Investigational Site 141

    Salt Lake City, Utah, 84108

  • Teva Investigational Site 104

    San Bernardino, California, 92408

  • Teva Investigational Site 110

    San Diego, California, 92108

  • Teva Investigational Site 169

    San Rafael, California, 94901

  • Teva Investigational Site 175

    St Louis, Missouri, 63104

  • Teva Investigational Site 161

    St Louis, Missouri, 63109

  • Teva Investigational Site 145

    Tuscaloosa, Alabama, 35404

  • Teva Investigational Site 156

    Washington D.C., District of Columbia, 20007

  • Teva Investigational Site 166

    Waukesha, Wisconsin, 53188

Other trials in United States

Poland19 sites

  • Teva Investigational Site 514

    Bełchatów, 97-400

  • Teva Investigational Site 554

    Bialystok, 15-756

  • Teva Investigational Site 510

    Bydgoszcz, 85-015

  • Teva Investigational Site 519

    Bydgoszcz, 85-080

  • Teva Investigational Site 536

    Bydgoszcz, 85-156

  • Teva Investigational Site 523

    Chełmno, 86-200

  • Teva Investigational Site 517

    Choroszcz, 16-070

  • Teva Investigational Site 513

    Gdansk, 80-952

  • Teva Investigational Site 512

    Katowice, 40-097

  • Teva Investigational Site 552

    Katowice, 40-123

  • Teva Investigational Site 520

    Krakow, 30-349

  • Teva Investigational Site 509

    Krakow, 31-505

  • Teva Investigational Site 508

    Lodz, 90-130

  • Teva Investigational Site 511

    Lublin, 20-064

  • Teva Investigational Site 524

    Lublin, 20-831

  • Teva Investigational Site 549

    Olsztyn, 10-443

  • Teva Investigational Site 522

    Torun, 87-100

  • Teva Investigational Site 550

    Warsaw, 00-465

  • Teva Investigational Site 516

    Wroclaw, 50-227

Other trials in Poland

Czechia6 sites

  • Teva Investigational Site 559

    Havířov, 736 01

  • Teva Investigational Site 556

    Hostivice, 999999

  • Teva Investigational Site 535

    Litoměřice, 412 01

  • Teva Investigational Site 557

    Pilsen, 312 00

  • Teva Investigational Site 533

    Prague, 100 00

  • Teva Investigational Site 530

    Prague, 16000

Other trials in Czechia

Hungary6 sites

  • Teva Investigational Site 540

    Balassagyarmat, 999999

  • Teva Investigational Site 538

    Budapest, 1135

  • Teva Investigational Site 541

    Budapest, 1148

  • Teva Investigational Site 539

    Doba, 8482

  • Teva Investigational Site 546

    Győr, H-9024

  • Teva Investigational Site 545

    Kalocsa, 6300

Other trials in Hungary

Slovakia5 sites

  • Teva Investigational Site 529

    Bratislava, 826 06

  • Teva Investigational Site 525

    Domaša, 935 61

  • Teva Investigational Site 527

    Košice, 04017

  • Teva Investigational Site 528

    Rimavská Sobota, 979 12

  • Teva Investigational Site 526

    Rožňava, 04801

Other trials in Slovakia

Germany2 sites

  • Teva Investigational Site 502

    Gera, 07551

  • Teva Investigational Site 504

    Mainz, 55131

Other trials in Germany

About this study

Official title: An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.

Read the detailed description

Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C.

Being tested
SD-809, Placebo
Keywords
Dyskinesias, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Signs and Symptoms
Medical subject headings
Tardive Dyskinesia, Dyskinesias, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Neurologic Manifestations, Signs and Symptoms

What participants receive

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

  • SD-809Drug

    Also called Deutetrabenazine; TEV-50717

    SD-809 will be administered per dose and schedule specified in the arm.

  • PlaceboDrug

    Placebo matching to SD-809 will be administered per schedule specified in the arm.

Study groups in NCT02198794
Study groupRoleWhat they receive
Part A: SD-809ExperimentalParticipants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.
Receives: Drug: SD-809
Part B: PlaceboPlacebo comparatorParticipants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks.
Receives: Drug: SD-809; Drug: Placebo
Part B: SD-809Active comparatorParticipants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks.
Receives: Drug: SD-809
Part C: SD-809ExperimentalEU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B.
Receives: Drug: SD-809

What is being measured

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

  1. Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal

    AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Measured: Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)

  2. Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Day 1 of Part B, Day 7 of Part B

Secondary outcomes (10)

  1. Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Baseline, Week 145

  2. Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Baseline, Week 158

  3. Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Baseline, Week 145

  4. Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Baseline, Week 158

  5. Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Baseline to Week 145

  6. Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.

    Measured: Baseline to Week 145

  7. Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating

    The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease.

    Measured: Baseline, Week 145

  8. Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC)

    A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.

    Measured: Baseline up to Week 145

  9. Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC)

    A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.

    Measured: Baseline up to Week 145

  10. Part A: Change From Baseline in Modified CDQ-24 Score at Week 158

    The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ-24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains were evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment.

    Measured: Baseline, Week 158

Timeline

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

  1. First posted24 Jul 2014 (estimated)
  2. Study start20 Oct 2014
  3. Primary completion6 Dec 2019
  4. Study completion14 Dec 2020

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
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02198794
Sponsor's protocol ID
SD-809-C-20
Other IDs
2014-001891-73, 2014
Acronym
RIM-TD
Status last verified
Mar 2022
First submitted
22 Jul 2014
Last updated
1 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)

Publications

  • Frank S, Anderson KE, Fernandez HH, Hauser RA, Claassen DO, Stamler D, Factor SA, Jimenez-Shahed J, Barkay H, Wilhelm A, Alexander JK, Chaijale N, Barash S, Savola JM, Gordon MF, Chen M. Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease. Neurol Ther. 2024 Jun;13(3):655-675. doi: 10.1007/s40120-024-00600-1. Epub 2024 Apr 1.

    PubMed 38557959

  • Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10.

    PubMed 31296586

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SD-809 in people with Tardive Dyskinesia, run by Auspex Pharmaceuticals, Inc. at 82 sites in 6 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 11 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Poland, Czechia, Hungary, Slovakia and 1 more country. 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 1 Mar 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?

Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal (time frame: Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)). 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 NCT02198794, 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 1 Apr 2022.

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