Intermittent Explosive DisorderPhase 2NCT03420222
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
A Phase 2 study testing AVP-786 in people with Intermittent Explosive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 9 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intermittent Explosive Disorder
- What is being tested?
- AVP-786
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 9 sitesUnited States
- Study dates
- 18 Jan 2018to 28 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
- Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version
- At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
- Score ≥ 12 on the Life History of Aggression scale at screening
- Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline
- Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline
Who cannot join
- Diagnosis of major depressive disorder within 6 months of screening
- Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening
- Met only the DSM-5 A2 criterion for IED
- Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
- Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
University of Chicago Medical Center Clinical Trial Site 2
Chicago, Illinois, 60637
Sarkis Clinical Trials
Gainesville, Florida, 32607
Atlea Research Institute
Las Vegas, Nevada, 89102
Research Institute Lindner Center of Hope/University of Cincinnati
Mason, Ohio, 45040
BTC of New Bedford
New Bedford, Massachusetts, 01740
Manhattan Behavioral Medicine
New York, New York, 10036
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
Read the detailed description
Eligible participants for this study must have a diagnosis of current IED.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.
- Conditions
- Intermittent Explosive Disorder
- Being tested
- AVP-786, Placebo
- Keywords
- Intermittent Explosive Disorder, AVP-786
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP-786Drug
oral capsules
PlaceboDrug
oral capsules
| Study group | Role | What they receive |
|---|---|---|
| AVP-786 | Experimental | Participants were to receive AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants were to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks. Receives: Drug: AVP-786 |
| Placebo | Placebo comparator | Participants were to receive placebo BID for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression.
Measured: Baseline; Week 12
Secondary outcomes (16)
Change From Baseline in the OAS-M Total Irritability Score at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M irritability domain includes 2 global assessment items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all to 5 = extreme). The 2 scores are added to create the OAS-M Total Irritability score (range = 0 to 10). Higher scores indicate increased irritability.
Measured: Baseline; Week 12
Change From Baseline in the OAS-M Individual Items for Aggression at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault). Higher scores indicate increased aggression.
Measured: Baseline; Week 12
Change From Baseline in the OAS-M Individual Items for Irritability at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M irritability domain includes 2 items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all; 5 = extreme). Higher scores indicate increased irritability.
Measured: Baseline; Week 12
Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12
The IED episodes were to be documented by the participants each evening before bedtime.
Measured: Baseline; Week 12
Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12
The IED episodes were to be documented by the participants each evening before bedtime and reviewed by the Investigator post dose.
Measured: Baseline; Week 12
Change From Baseline in the Number of IED Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes.
Measured: Baseline; Week 12
Change From Baseline in the Severity of IED Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of the worst episode (0 = not severe at all to 10 = worst severity imaginable).
Measured: Baseline; Week 12
Change From Baseline in the Severity of Distress From Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of distress experienced by the episode(s) (0 = no distress to 10 = worst distress imaginable).
Measured: Baseline; Week 12
Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M includes information regarding the number of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) A1 aggressive episodes, and the number of DSM-5 A2 aggressive episodes experienced by the participants during the past week. The number of discrete IED episodes is calculated after an interview with the participant. Episodes identified as discrete are separated by at least 30 minutes; episodes separated by less than 30 minutes are considered a single episode.
Measured: Baseline; Week 12
Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12
The mCGI-S is a modified version of the CGI-S scale that provides a global evaluation of the participant's IED symptoms (e.g., aggression, anger, and irritability). The mCGI-S scale measures the severity of the participant's symptoms from the clinician's perspective in the context of other participants with IED. The mCGI-S responses are scored on a 7- point scale (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants).
Measured: Baseline; Week 12
Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12
The mCGI-C is a modified version of the CGI-C scale. The clinician rates the overall global change in the participant's IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double- blind visits. The mCGI-C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Measured: Baseline; Week 12
Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12
The mPGI-S is a single-question scale. Participants rate the overall global severity of their IED symptoms (e.g., aggression, anger, and irritability) using a 7-point scale (1 = normal, no symptoms; 2 = borderline symptoms; 3 = mild symptoms; 4 = moderately bad symptoms; 5 = markedly bad symptoms; 6 = severely bad symptoms; 7 = extremely bad symptoms).
Measured: Baseline; Week 12
Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12
The mPGI-C is a single-question scale. Participants rate the overall global change in their IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double-blind visits. The mPGI- C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Measured: Baseline; Week 12
Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12
The SDS is a 3-item, participant-rated questionnaire used to evaluate impairments in the domains of work/school, social life or leisure activities, and family life or home responsibility. Participants rate the degree of impairment in work/school, social life or leisure activities, and family life or home responsibility as a result of IED symptoms using a visual analogue scale (0 = no impairment; 1, 2, 3 = mildly; 4, 5, 6 = moderately; 7, 8, 9 = markedly; 10 = extremely). Only those score categories with at least one participant with event are reported.
Measured: Baseline; Week 12
Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12
The SF-12 is a 12-item, participant self-rated questionnaire used to measure the general health status and quality of life. The SF-12 includes questions to measure the effects of health on physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100. Higher scores indicate better health status.
Measured: Baseline; Week 12
Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12
The STAXI-2 is a 57-item, participant self-rated scale used to measure the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). The STAXI-2 includes a measure of state anger, trait anger, anger expression-out, anger expression-in, anger control-out and anger control, and the anger expression index (an overall measure of the expression and control of anger). The state anger items are scored using a 4-point scale (1 = not at all to 4 = very much so) to assess the intensity of anger feelings at a particular moment. The other scales are scored using a 4- point scale to assess how frequently angry feelings are experienced, expressed, suppressed, or controlled (1 = almost never to 4 = almost always).
Measured: Baseline; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start18 Jan 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Why it stopped: Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.
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 Intermittent Explosive DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420222
- Sponsor's protocol ID
- 17-AVP-786-206
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2018
- Last updated
- 24 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)
- ClinicalTrials.gov ID
- NCT03420222
- Acronym / sponsor ID
- 17-AVP-786-206
- Conditions
- Intermittent Explosive Disorder
- Keywords
- Intermittent Explosive Disorder, AVP-786
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 24 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
Detailed description
Eligible participants for this study must have a diagnosis of current IED.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVP-786 | Experimental | Drug: AVP-786Participants were to receive AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants were to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants were to receive placebo BID for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version
- At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
- Score ≥ 12 on the Life History of Aggression scale at screening
- Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline
- Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline
Key exclusion criteria (5 listed)
- Diagnosis of major depressive disorder within 6 months of screening
- Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening
- Met only the DSM-5 A2 criterion for IED
- Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
- Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
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 |
|---|---|---|
| AVP-786oral capsules | Drug | AVP-786 |
| Placebooral capsules | Drug | Placebo |
Primary outcome
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
Time frame: Baseline; Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression.
16 secondary outcomes
Change From Baseline in the OAS-M Total Irritability Score at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the OAS-M Individual Items for Aggression at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the OAS-M Individual Items for Irritability at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Number of IED Episodes at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Severity of IED Episodes at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Severity of Distress From Episodes at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12
Time frame: Baseline; Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 AVP-786 in people with Intermittent Explosive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 9 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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 24 May 2022). 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 the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12 (time frame: Baseline; Week 12). 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 24 May 2022.