Attention Deficit Hyperactivity DisorderPhase 3NCT03659929
Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
A Phase 3 study testing Amphetamine Sulfate in people with Attention Deficit Hyperactivity Disorder, run by Arbor Pharmaceuticals, Inc. at 31 sites in United States.
Trial summary
The purpose of the AR19.004 study is to assess the efficacy of AR19 compared to placebo using the Adult ADHD Investigator Symptom Rating Scale (AISRS) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Amphetamine Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 31 sitesUnited States
- Study dates
- 18 Sep 2018to 12 Apr 2019
- 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
- Is male or female between 18 and 55 years of age, inclusive, at the time of Screening.
- Meets criteria for diagnosis of ADHD using Conners' Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV™) adapted for DSM-5™ (CAADID), including onset of ADHD symptoms before the age of 12.
- Has an AISRS total score of ≥26 at Visit 2.
- Has a clinician-administered Clinical Global Impression-Severity (CGI-S) score of 4 or greater at Visit 2.
- In the clinical judgment of the Investigator, the subject needs pharmacological treatment for ADHD.
- Must read and write English at a level sufficient to provide written informed consent and to complete study-related materials.
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- For subjects currently on a stable dose of allowed non-ADHD medication, there will be no expected changes in subject's medications during the study with the exception of medications listed in Section 5.9.2.
- Males and females who are fertile and sexually active with a partner of the opposite sex must adhere to contraception requirements for the duration of the study as follows:
- Females of childbearing potential must agree to be abstinent or to use highly effective forms of contraception.
- Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months do not require contraception during the study.
- Males , with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception from screening through the end of study.
Who cannot join
- Has a primary psychiatric diagnosis other than ADHD.
- Has any other current secondary or co-morbid medical, psychiatric, or social condition which, in the opinion of the investigator, might compromise subject safety, or is likely to interfere with protocol compliance or to confound the assessment of safety or efficacy.
- Has a history or current symptoms of bipolar disorder, schizophrenia, or psychotic disorder.
- Has clinically significant cognitive impairment in the clinical judgment of the Investigator.
- Has a Body Mass Index (BMI) of <17 or ≥39 kg/m2.
- Has a Screening or Baseline triplicate-average blood pressure of ≥139 millimeter of mercury (mmHg) systolic or ≥89 mmHg diastolic. Blood pressure will be taken in triplicate, and the average will be used for evaluating entry criteria.
Show all 47Show fewer
- Is pregnant or breastfeeding, or is planning to become pregnant during the study.
- Has a history of any of the following disorders:
- Seizure disorder (excluding a history of isolated febrile seizures <6 years old),
- Inadequately or not treated hypertension is defined as a subject who has blood pressure indicative of Stage 2 hypertension (systolic pressure ≥140 mmHg or diastolic pressure ≥90 mmHg). Subjects who are adequately treated must be on a stable dose of antihypertensive medications for 3 months prior to screening and their antihypertensive medications are not anticipated to change.
- Untreated thyroid disease. Subjects with a history of thyroid disease who have been on a stable dose of thyroid hormone for at least three months are eligible to participate if their thyroid-stimulating hormone (TSH) does not fall in the excluded range, shown below in 14.
- Glaucoma
- Tourette's disorder, or chronic tics.
- Subjects who have had gastrointestinal surgery or a procedure that involves:
- Excision or partial excision of the esophagus, stomach, small and large intestine, liver, pancreas or biliary tree. Appendectomy, cholecystectomy and/or removal of gallstones in the bile ducts (as long as the ducts remain intact) are exceptions.
- Reduction of the stomach volume without excision or partial excision of the stomach (e.g. restrictive surgery/procedure)
- Obesity treatments that can affect gastrointestinal (GI) capacity or function, such as electrical stimulation systems, gastric balloon systems, and gastric external drainage systems
- Has Electrocardiogram (ECG) or clinical evidence of the following:
- Fridericia's corrected QT wave interval (QTcF) > 470 milliseconds (msec) for females, and > 450 msec for males
- Atrial or ventricular hypertrophy
- Intraventricular conduction defects other than incomplete right bundle branch block in the absence of other heart disease
- Myocardial infarct, ischemia, or symptomatic coronary artery disease within 1 year prior to the Screening Visit
- Clinically significant atrial or ventricular dysrhythmia; the heart must be in predominantly normal sinus rhythm
- Second or third degree atrioventricular block
- Heart failure
- Functionally significant cardiac structural abnormality or valvular disease
- Cardiomyopathy
- Any other cardiovascular condition that the Investigator feels may predispose the subject to cardiovascular events (e.g. myocardial infarction, stroke) or arrhythmia
- Known family history of sudden cardiac death in the absence of pre-existing heart disease.
- Use of any psychotropic medication within 28 days of the Baseline visit except for ADHD medication. (Sedative hypnotics prescribed as a sleep aid at a stable dose for at least 28 days prior to Baseline, at bedtime only, are allowed during the study.)
- Has used prohibited drugs or agents within 28 days of the Baseline visit through Study Visit 7. (Stimulant medications are allowed until 7 days before the Baseline visit.) Non-stimulant ADHD medications (guanfacine, bupropion, clonidine, and/or atomoxetine) are not allowed within 28 days of Visit 2 or at any time during the study. Note: Medications that are being taken for psychiatric or medical disorders other than ADHD should not be discontinued for the purpose of qualifying for study participation unless the medication is deemed medically unnecessary by the prescribing physician.
- Has received an investigational drug within 60 days of the Screening visit.
- Has an abnormal laboratory test value, vital sign, or other exam finding at Screening or Baseline that, in the opinion of the Investigator, warrants exclusion from the study. In addition, subjects with laboratory values listed below are considered exclusionary:
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >1.5 × upper limit of normal (ULN)
- Serum total bilirubin >1.5 × ULN unless due to Gilbert's Syndrome
- Serum creatinine >1.3 × ULN
- Glycosylated hemoglobin (HbA1c) ≥7.0%.
- TSH <0.9 × lower limit of normal (LLN) or TSH >1.2 × ULN
- Reports a history of hypersensitivity or intolerance to any formulation of amphetamine.
- Reports a history of poor therapeutic response to any formulation of amphetamine or methylphenidate despite a clearly adequate trial (including dose and duration).
- Is unable to swallow medication in capsule form.
- Is unable or unwilling to follow directions of study staff or comply with all the testing and requirements of the protocol.
- Has a positive urine drug result at Screening (with the exception of current ADHD stimulant therapy, if any). Note: subjects should be informed that they should not participate in the trial or submit to urine drug testing if they are using any controlled or recreational drug (other than a prescribed stimulant for ADHD), and non-use should be confirmed prior to testing.
- Has a positive blood alcohol level at Screening. Note: subjects should be informed that alcohol consumed within 12 hours of screening may result in a positive test.
- Has current or known history of drug or alcohol abuse within the past 12 months.
- Has a history of human immunodeficiency virus (HIV), hepatitis B, or untreated hepatitis C infection. Note: subjects with a history of hepatitis C infection who have been treated and whose hepatitis C virus ribonucleic acid (HCV RNA) is currently undetectable are not excluded.
- In the past 12 months, has had an intensity of suicidal ideation of greater than 1or any self-injurious behavior using the Columbia Suicide Severity Rating Scale at the Screening or Baseline visits.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
125: Biobehavioral Research of Austin
Austin, Texas, 78759
116: Alliance - Hassman Research Institute
Berlin, New Jersey, 08009
108: Meridien Research
Bradenton, Florida, 34201
119: Neurobehavioral Clinical Research, Inc.
Canton, Ohio, 44718
127: Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
109: Ericksen Research and Development
Clinton, Utah, 84405
121: CT Clinical Research Associates
Cromwell, Connecticut, 06416
110: FutureSearch Trials of Dallas
Dallas, Texas, 75231
114: Pharmacology Research Institute
Encino, California, 91316
103: Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
129: Sarkis Clinical Trials
Gainesville, Florida, 32607
133: Collaborative Neuroscience Network
Garden Grove, California, 92845
117: Houston Clinical Trials, LLC
Houston, Texas, 77005
105: Meridien Research
Lakeland, Florida, 33805
107: Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
113: Capstone Clinical Research
Libertyville, Illinois, 60048
120: Meridien Research
Maitland, Florida, 32751
104: Northwest Behavioral Research Center
Marietta, Georgia, 30060
102: Clinical Neuroscience Solutions (CNS), Inc.
Memphis, Tennessee, 38119
132: Research Strategies of Memphis
Memphis, Tennessee, 38119
131: Advanced Clinical Research, Inc.
Meridian, Idaho, 86342
118: Bioscience Research, LLC
Mount Kisco, New York, 10549
126: Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464
124: Pharmacology Research Institute
Newport Beach, California, 92660
130: Medical Research Group of Central Florida
Orange City, Florida, 32763
123: APG Research, LLC
Orlando, Florida, 32803
115: Clinical Neuroscience Solutions (CNS), Inc.
Orlando, Florida, 32806
106: Summit Research Network
Portland, Oregon, 97210
101: Princeton Medical Institute
Princeton, New Jersey, 08540
134: Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
128: Clinical Neurophysiology Services
Sterling, Michigan, 48314
About this study
Official title: A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of the AR19.004 study is to assess the efficacy of AR19 compared to placebo using the Adult ADHD Investigator Symptom Rating Scale (AISRS)
Read the detailed description
This is a randomized, fixed-dose, double-blind, multicenter trial to investigate the safety and efficacy of AR19 in the treatment of ADHD in adults from 18 through 55 years of age. Safety parameters and therapeutic effect will be evaluated throughout the trial. A target of 312 subjects is set for enrollment. Once subjects are determined to meet all inclusion criteria and were screened, they will be randomized to 20 or 40 mg AR19 daily or placebo.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Amphetamine Sulfate, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphetamine SulfateDrug
Also called AR19
active experimental AR19
PlaceboDrug
Also called inactive drug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 20 mg/day | Experimental | Amphetamine Sulfate Receives: Drug: Amphetamine Sulfate |
| Arm 2: 40 mg/day | Experimental | Amphetamine Sulfate Receives: Drug: Amphetamine Sulfate |
| Arm 3: Placebo | Placebo comparator | Placebo, no active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms
Change from baseline in severity of Attention Deficit Hyperactivity (ADHD) symptoms, as measured by the adult ADHD Investigator Symptom Rating Scale (AISRS), with a minimum score of 0, and maximum score of 54. Higher scores indicate more severe symptoms, or a worse outcome.
Measured: Week 5 (Visit 7)
Secondary outcomes (4)
Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores
Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale (summed). The total score is the sum of the inattentive and hyperactive-impulsive subscales. Higher values represent more severe hyperactivity and/or inattentiveness.
Measured: Up to 5 weeks
Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline
CGI-Severity (CGI-S): The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Measured: Up to 5 weeks
Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline
"Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."
Measured: Up to 5 weeks
Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline
The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is a 75-item self-rating scale that assesses overall functioning (GEC) and 9 non-overlapping scales among 2 summary index scales (Metacognition Index [MI] and Behavioral Regulation Index [BRI]) that assess aspects of executive function and problems with self-regulation from the perspective of the individual.
Subjects rate each item on a 3-point scale (1=Never, 2=Sometimes, or 3=Often) based on their experience in past month.
The sum of 70 items yields the GEC raw score (range: 70-210), which is converted to a T-score (normative population mean=50 and standard deviation=10; T-score ≥ 65 is considered abnormally elevated). The post-baseline GEC T-score is converted to a change from baseline T-score.
A lower change from baseline GEC T-score (<0) represents a better outcome.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start18 Sep 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Caras, MD, PhD, Study director, Arbor Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659929
- Sponsor's protocol ID
- AR19.004
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2018
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faraone SV, Childress A, Caras S, Arnold VK, Montano CB, Sarkis EH, Cutler AJ, Young JL. A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AR19, a Manipulation-Resistant Formulation of Amphetamine Sulfate, in Adults With Attention-Deficit/Hyperactivity Disorder. J Clin Psychiatry. 2021 Aug 24;82(5):21m13927. doi: 10.4088/JCP.21m13927.
PubMed 34428356
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT03659929
- Acronym / sponsor ID
- AR19.004
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the AR19.004 study is to assess the efficacy of AR19 compared to placebo using the Adult ADHD Investigator Symptom Rating Scale (AISRS)
Detailed description
This is a randomized, fixed-dose, double-blind, multicenter trial to investigate the safety and efficacy of AR19 in the treatment of ADHD in adults from 18 through 55 years of age. Safety parameters and therapeutic effect will be evaluated throughout the trial. A target of 312 subjects is set for enrollment. Once subjects are determined to meet all inclusion criteria and were screened, they will be randomized to 20 or 40 mg AR19 daily or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: 20 mg/day | Experimental | Drug: Amphetamine SulfateAmphetamine Sulfate |
| Arm 2: 40 mg/day | Experimental | Drug: Amphetamine SulfateAmphetamine Sulfate |
| Arm 3: Placebo | Placebo comparator | Drug: PlaceboPlacebo, no active drug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is male or female between 18 and 55 years of age, inclusive, at the time of Screening.
- Meets criteria for diagnosis of ADHD using Conners' Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV™) adapted for DSM-5™ (CAADID), including onset of ADHD symptoms before the age of 12.
- Has an AISRS total score of ≥26 at Visit 2.
- Has a clinician-administered Clinical Global Impression-Severity (CGI-S) score of 4 or greater at Visit 2.
- In the clinical judgment of the Investigator, the subject needs pharmacological treatment for ADHD.
Key exclusion criteria (47 listed)
- Has a primary psychiatric diagnosis other than ADHD.
- Has any other current secondary or co-morbid medical, psychiatric, or social condition which, in the opinion of the investigator, might compromise subject safety, or is likely to interfere with protocol compliance or to confound the assessment of safety or efficacy.
- Has a history or current symptoms of bipolar disorder, schizophrenia, or psychotic disorder.
- Has clinically significant cognitive impairment in the clinical judgment of the Investigator.
- Has a Body Mass Index (BMI) of <17 or ≥39 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphetamine SulfateAlso: AR19active experimental AR19 | Drug | Arm 1: 20 mg/day, Arm 2: 40 mg/day |
| PlaceboAlso: inactive drugMatching placebo | Drug | Arm 3: Placebo |
Primary outcome
Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms
Time frame: Week 5 (Visit 7)
Change from baseline in severity of Attention Deficit Hyperactivity (ADHD) symptoms, as measured by the adult ADHD Investigator Symptom Rating Scale (AISRS), with a minimum score of 0, and maximum score of 54. Higher scores indicate more severe symptoms, or a worse outcome.
4 secondary outcomes
Change From Baseline to Visit 7 in AISRS Hyperactive and Inattentive Subscale Scores
Time frame: Up to 5 weeks
Change in Clinical Global Impression of Severity (CGI-S) Score From Baseline
Time frame: Up to 5 weeks
Change in Clinical Global Impression of Improvement (CGI-I) Score From Baseline
Time frame: Up to 5 weeks
Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Score From Baseline
Time frame: Up to 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34428356Faraone SV, Childress A, Caras S, Arnold VK, Montano CB, Sarkis EH, Cutler AJ, Young JL. A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AR19, a Manipulation-Resistant Formulation of Amphetamine Sulfate, in Adults With Attention-Deficit/Hyperactivity Disorder. J Clin Psychiatry. 2021 Aug 24;82(5):21m13927. doi: 10.4088/JCP.21m13927.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Caras, MD, PhD study director
Arbor Pharmaceuticals
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amphetamine Sulfate in people with Attention Deficit Hyperactivity Disorder, run by Arbor Pharmaceuticals, Inc. at 31 sites in United States.
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 11 inclusion and 47 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 3 Sep 2024). 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?
Change From Baseline in Severity of Attention Deficit Hyperactivity (ADHD) Symptoms (time frame: Week 5 (Visit 7)). 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 NCT03659929, which also lists 1 linked publication.
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 3 Sep 2024.