EpilepsyPhase 2NCT03179891
Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
A Phase 2 study testing Diazepam Buccal Film 12.5 mg in people with Epilepsy, run by Aquestive Therapeutics at 11 sites in United States.
Trial summary
This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation of their seizures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Diazepam Buccal Film 12.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 11 sitesUnited States
- Study dates
- 25 May 2017to 21 Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential subjects meeting all of the following criteria may be included in the study:
- Subjects scheduled for admission to the institution's EMU, GCRC (General Clinical Research Center) or similar facility for evaluation within 28 days.
- Male and female subjects between 18 to 65 years of age, inclusive.
- Subjects having a body weight of ≥ 40 kg to 111 kg.
- Subjects have a clinical diagnosis of epilepsy and are scheduled to be admitted to an Epilepsy Monitoring Unit (EMU) for extracranial video-Electroencephalogram (EEG) recording of a seizure event for evaluation of their epilepsy.
- Subjects have an average frequency of > 1 seizure every 3 days or > 10 seizures / month as documented by seizure diaries dispensed at the Screening Visit and verified prior to initiation of Period A or Period B.
Show all 13Show fewer
- Female subjects have a negative serum pregnancy test at Screening. Female subjects of childbearing potential (i.e., not surgically sterile or 2 years postmenopausal) must have a negative pregnancy test at screening and a partner who is sterile, agree to abstinence, be practicing double barrier contraception or using an FDA approved contraceptive (e.g., licensed hormonal or barrier methods) for greater than 2 months prior to screening visit and commit to an acceptable form of birth control for the duration of the study and for 30 days after participation in the study.
- Subjects are currently receiving at least one antiepileptic medication.
- Subjects or subject's legally authorized representative (LAR) must be willing and able to complete informed consent/assent and HIPAA authorization.
- Subjects must agree and must be willing to comply with all required study procedures while in the EMU or GCRC.
- Ability to comprehend and be informed of the nature of the study, as assessed by the PI or Sub-Investigator.
- Ability to consume standard meals.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
Who cannot join
- Potential subjects meeting any of the following criteria will be excluded:
- Subjects having a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months.
- Subjects having respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen.
- Female subjects who are lactating or positive serum pregnancy test (ß-hCG) at screening for female subjects ≥12 years of age.
- Subjects with severe psychiatric disease that in the Investigator's judgment would prevent the patient's successful completion of the study.
- Subjects who have an episode of status epilepticus, as determined by the Principal Investigator/Sub-Investigator, at any time during Period B (EMU, GCRC or similar facility Visit
Show all 21Show fewer
- Subjects with known history or presence of any clinically significant hepatic (e.g. hepatic impairment), renal/genitourinary (renal impairment, kidney stones), psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator and confirmed by Sponsor via written communication prior to subject enrollment.
- Subjects with any clinically significant illness other than epilepsy within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator.
- Subjects with any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
- Subjects with any significant lesion of the oral cavity or having oral prophylactic procedures within 30 days prior to first dosing.
- Subjects with a QTc interval QTcF>450 msec for males and QTcF>470 msec for females on screening ECG, unless determined as not clinically significant by the Investigator.
- Subjects with a positive test result for any of the following: drugs of abuse (amphetamines, cocaine, opiates, or phencyclidine), a positive breath alcohol test.
- Subjects with a known history or presence of: a. Alcohol abuse or dependence within one year prior to first drug administration; b. Drug abuse or dependence; c. Hypersensitivity or idiosyncratic reaction to diazepam, its excipients, sodium phosphates; and/or related substances, e.g. benzodiazepines; d. Glaucoma (open or acute narrow angle); e. Severe allergic reactions (e.g. anaphylactic reactions, angioedema
- Subjects who have participated in another clinical trial or who received an investigational drug within 30 days prior to first drug administration or 5 half-lives of the investigational drug-whichever is the longer period.
- Blood or plasma donation within 30 days prior to Screening
- Subjects not willing or unable to tolerate blood draws.
- Subjects who have received any other dosage form of diazepam or benzodiazepines within 2 weeks prior to entering Period A or Period B.
- Consumption of alcohol within 48 hours before dosing and food or beverages containing grapefruit, star fruit, Seville oranges, and/or pomelo or their derived products (e.g., fruit juice) within 10 days prior to first drug administration.
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g. cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, or HIV antivirals) and strong inducers of CYP enzymes (e.g. glucocorticoids, St. John´s Wort, or rifampicin) in the previous 30 days before first drug administration [barbiturates, carbamazepine, and phenytoin are allowed since these are common AEDs (Anti-epileptic drugs)].
- Use of any monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine), phenothiazines (chlorpromazine) within 30 days prior to first drug administration.
- Employee or immediate relative of an employee of the investigator, MonoSol Rx LLC, any of its affiliates or partners, or inVentiv Health.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Austin Epilepsy Care Center
Austin, Texas, 78758
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Onsite Clinical Solutions LLC
Charlotte, North Carolina, 28203
Rancho Research Institute
Downey, California, 90242
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Yale University School of Medicine-Comprehensive Epilepsy Center
New Haven, Connecticut, 06520-8018
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
University of Rochester Medical Center
Rochester, New York, 14642
Arizona Health Sciences Center
Tucson, Arizona, 85724-5023
About this study
Official title: A Multicenter, Open Label, Crossover Study to Assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Adult Subjects With Epilepsy
This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation of their seizures. All subjects received a single DBF 12.5 mg dose during the Interictal State and a single DBF 12.5 mg dose during the Ictal/peri-ictal state with at least 14 days washout between the 2 doses.
Read the detailed description
This was a Phase 2 multicenter, open-label, two-way study conducted in adult subjects to assess the bioavailability, pharmacokinetics, and safety of DBF during the Interictal Period and during the Ictal/peri-ictal Period, with a minimum of 14 days of washout between periods. Subjects had a clinical diagnosis of epilepsy (with generalized tonic-clonic seizures or focal seizures with impaired awareness) who were on stable regimens of anti-epileptic drugs and were scheduled for admission to an EMU, GCRC, or similar facility for evaluation.
All subjects were to receive a single 12.5-mg dose of study drug, without regard to meals, during both Interictal Period and Ictal/peri-ictal Period. The treatment was identical for both periods. Treatment sequence was not randomized. The interictal period and ictal/peri-ictal could occur in either order as determined by seizure occurrence.
Interictal Period: Subjects were considered to be in an interictal state if an interval of at least 3 hours had elapsed since any clinically observable postictal signs or symptoms (from the last observed seizure) and the subject had been seizure-free over this period. Subjects on electroencephalogram (EEG) video monitoring were to be considered to be in an interictal state if an interval of at least 3 hours had elapsed since there were any postictal electrical findings on EEG.
Ictal/peri-ictal Period: For the purposes of this study, the ictal state was defined as an ongoing clinically observable seizure or seizure activity as verified via EEG. The periictal state was defined clinically as the subject's immediate postictal state following a generalized tonic-clonic (GTC) seizure or focal seizure with impaired awareness, and within 5 minutes following the last clonic jerk. For subjects on EEG video monitoring, the periictal state was to be defined as less than 5 minutes after cessation of seizure activity as verified via EEG.
- Conditions
- Epilepsy
- Being tested
- Diazepam Buccal Film 12.5 mg
- Keywords
- Interictal, Ictal/peri-ictal
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam Buccal Film 12.5 mgDrug
Also called DBF 12.5mg
All subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods
| Study group | Role | What they receive |
|---|---|---|
| Interictal Period | Experimental | All subjects received 12.5 mg DBF during the interictal state. Receives: Drug: Diazepam Buccal Film 12.5 mg |
| Ictal/Peri-ictal Period | Experimental | All subjects received 12.5 mg DBF during the ictal/peri-ictal state. Receives: Drug: Diazepam Buccal Film 12.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax Pharmacokinetic EndPoints
Observed time to reach maximum drug concentration (Tmax)
Measured: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours
Cmax Pharmacokinetic EndPoints
Observed Peak Drug Concentration (Cmax)
Measured: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours
Area Under the Plasma Concentration Curve Pharmacokinetic EndPoints
Area under the Plasma Concentration -time curve from time zero until the last measured time (AUC0-t)
Measured: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours
Secondary outcomes (5)
Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt
Number of subjects with unsuccessful insertion/placement of the DBF on first attempt at administration Number of subjects with successful insertion/placement of the DBF on first attempt at administration
Placement is judged to be successful when film adheres to the center of buccal mucosa of either right or left cheek.
Unsuccessful placements were followed by a subsequent successful insertion/placement of DBF
Measured: Subject was observed for 15 minutes after initial film placement/adhesion
Usability Endpoint: Swallowing the Film Before Complete Disintegration/Dissolution
Was the film noted to have been swallowed by the subject ? Yes No
Subjects were instructed to swallow any remnants of film still present in oral cavity 15 minutes after initial film placement.
Results include subjects who swallowed film at any point during the 15 minutes immediately after initial film placement.
Measured: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete Disintegration
Was the DBF spit out or blown out by the subject after placement on buccal mucosa or did the subject chew, talk, or move the DBF prior to complete disintegration/dissolution? Yes No
Measured: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Usability Endpoint: Exit of Saliva During the Time the Diazepam Buccal Film (DBF) Was Adhered to Buccal Mucosa
The observer documented if any saliva was seen to exit the mouth during the time the DBF was adhered to buccal mucosa
Measured: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Usability Endpoint: Amount of Saliva That Exited the Mouth After Film Placement
If Yes - saliva exited the mouth during the time, estimate in milliliters of the amount of saliva that exited the mouth after DBF placement on the buccal surface
Measured: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start25 May 2017
- Primary completion25 Jul 2018
- Study completion21 Dec 2018
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.
- Other trials for EpilepsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This was a multicenter, open-label study comprised of 2 treatment periods with a minimum 14 days washout between the 2 treatment periods.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquestive Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical, Covance
- Responsible party
- Sponsor
- Investigators
- Gary Slatko, Study director, Aquestive Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179891
- Sponsor's protocol ID
- 160326
- Status last verified
- Sep 2020
- First submitted
- 26 May 2017
- Last updated
- 18 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Crossover Study to Assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Adult Subjects With Epilepsy
- ClinicalTrials.gov ID
- NCT03179891
- Acronym / sponsor ID
- 160326
- Conditions
- Epilepsy
- Keywords
- Interictal, Ictal/peri-ictal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Aquestive TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical, Covance
- Study start
- 25 May 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation of their seizures. All subjects received a single DBF 12.5 mg dose during the Interictal State and a single DBF 12.5 mg dose during the Ictal/peri-ictal state with at least 14 days washout between the 2 doses.
Detailed description
This was a Phase 2 multicenter, open-label, two-way study conducted in adult subjects to assess the bioavailability, pharmacokinetics, and safety of DBF during the Interictal Period and during the Ictal/peri-ictal Period, with a minimum of 14 days of washout between periods. Subjects had a clinical diagnosis of epilepsy (with generalized tonic-clonic seizures or focal seizures with impaired awareness) who were on stable regimens of anti-epileptic drugs and were scheduled for admission to an EMU, GCRC, or similar facility for evaluation.
All subjects were to receive a single 12.5-mg dose of study drug, without regard to meals, during both Interictal Period and Ictal/peri-ictal Period. The treatment was identical for both periods. Treatment sequence was not randomized. The interictal period and ictal/peri-ictal could occur in either order as determined by seizure occurrence.
Interictal Period: Subjects were considered to be in an interictal state if an interval of at least 3 hours had elapsed since any clinically observable postictal signs or symptoms (from the last observed seizure) and the subject had been seizure-free over this period. Subjects on electroencephalogram (EEG) video monitoring were to be considered to be in an interictal state if an interval of at least 3 hours had elapsed since there were any postictal electrical findings on EEG.
Ictal/peri-ictal Period: For the purposes of this study, the ictal state was defined as an ongoing clinically observable seizure or seizure activity as verified via EEG. The periictal state was defined clinically as the subject's immediate postictal state following a generalized tonic-clonic (GTC) seizure or focal seizure with impaired awareness, and within 5 minutes following the last clonic jerk. For subjects on EEG video monitoring, the periictal state was to be defined as less than 5 minutes after cessation of seizure activity as verified via EEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a multicenter, open-label study comprised of 2 treatment periods with a minimum 14 days washout between the 2 treatment periods.
| Arm | Type | Receives |
|---|---|---|
| Interictal Period | Experimental | Drug: Diazepam Buccal Film 12.5 mgAll subjects received 12.5 mg DBF during the interictal state. |
| Ictal/Peri-ictal Period | Experimental | Drug: Diazepam Buccal Film 12.5 mgAll subjects received 12.5 mg DBF during the ictal/peri-ictal state. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects scheduled for admission to the institution's EMU, GCRC (General Clinical Research Center) or similar facility for evaluation within 28 days.
- Male and female subjects between 18 to 65 years of age, inclusive.
- Subjects having a body weight of ≥ 40 kg to 111 kg.
- Subjects have a clinical diagnosis of epilepsy and are scheduled to be admitted to an Epilepsy Monitoring Unit (EMU) for extracranial video-Electroencephalogram (EEG) recording of a seizure event for evaluation of their epilepsy.
- Subjects have an average frequency of > 1 seizure every 3 days or > 10 seizures / month as documented by seizure diaries dispensed at the Screening Visit and verified prior to initiation of Period A or Period B.
Key exclusion criteria (21 listed)
- Subjects having a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months.
- Subjects having respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen.
- Female subjects who are lactating or positive serum pregnancy test (ß-hCG) at screening for female subjects ≥12 years of age.
- Subjects with severe psychiatric disease that in the Investigator's judgment would prevent the patient's successful completion of the study.
- Subjects who have an episode of status epilepticus, as determined by the Principal Investigator/Sub-Investigator, at any time during Period B (EMU, GCRC or similar facility Visit
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 |
|---|---|---|
| Diazepam Buccal Film 12.5 mgAlso: DBF 12.5mgAll subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods | Drug | Ictal/Peri-ictal Period, Interictal Period |
Primary outcome
Tmax Pharmacokinetic EndPoints
Time frame: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours
Observed time to reach maximum drug concentration (Tmax)
Cmax Pharmacokinetic EndPoints
Time frame: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours
Observed Peak Drug Concentration (Cmax)
Area Under the Plasma Concentration Curve Pharmacokinetic EndPoints
Time frame: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours
Area under the Plasma Concentration -time curve from time zero until the last measured time (AUC0-t)
5 secondary outcomes
Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt
Time frame: Subject was observed for 15 minutes after initial film placement/adhesion
Usability Endpoint: Swallowing the Film Before Complete Disintegration/Dissolution
Time frame: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete Disintegration
Time frame: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Usability Endpoint: Exit of Saliva During the Time the Diazepam Buccal Film (DBF) Was Adhered to Buccal Mucosa
Time frame: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Usability Endpoint: Amount of Saliva That Exited the Mouth After Film Placement
Time frame: Subject was observed for 15 minutes immediately following DBF placement/adhesion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gary Slatko study director
Aquestive Therapeutics
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diazepam Buccal Film 12.5 mg in people with Epilepsy, run by Aquestive Therapeutics at 11 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 13 inclusion and 21 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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 18 Sep 2020). 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?
Tmax Pharmacokinetic EndPoints (time frame: -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2020.