EoEPhase 2NCT03656380
Mepo for Eosinophilic Esophagitis (EoE) Study
A Phase 2 study testing Mepolizumab 300 mg and Mepolizumab 100 mg in people with EoE and Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an initial 3 month… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- EoE, Eosinophilic Esophagitis
- What is being tested?
- Mepolizumab 300 mg and Mepolizumab 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2019to 9 Dec 2022
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-75
- Diagnosis of EoE (eosinophilic esophagitis) as per consensus guidelines (including PPI non-response)*
- Active eosinophilia on esophageal biopsy, with a peak count of least 15 EOS/hpf (eosinophils per high power field) from at least one esophageal level.
- Biopsies from the stomach and duodenum that have ruled out alternative etiologies in all children and in adults with abnormal endoscopic findings or when other gastric or small intestinal conditions are clinical possibilities. If these samples have been obtained during a previous endoscopic evaluation and in the judgement of the site-Investigator the patient has not had a clinically significant change that would merit repeat gastric/duodenal biopsies, then prior normal gastric and duodenal biopsies are acceptable to exclude alternate etiologies.
- Active symptoms of dysphagia with more than 3 episodes of dysphagia over a period of 2 weeks during the screening period, and an Eosinophilic Esophagitis Symptom Activity Index (EEsAI; see below for details) score of ≥ 27 at baseline.
- Able to read, comprehend, and sign consent form.
Show all 10Show fewer
- Have maintained a stable diet for 6 weeks prior to enrollment.
- Able to maintain a stable diet throughout the duration of the study period.
- Female subjects of childbearing potential who have had their first menses agree to use a highly effective method of birth control during the study and for 30 days after the last dose of study drug. Female subjects with reproductive potential who are using systemic contraceptives (e.g., oral contraceptives, injectable contraceptives, implantable/insertable hormonal contraceptive products, or transdermal patches) to prevent pregnancy must have stable use for ≥28 days prior to screening.
- PPI non-response is defined as >15 eos/hpf after at least 6 weeks of high dose administration (40mg total per day or higher) of any approved PPI medication or documented evidence of intolerance or allergy to PPIs. The length of the PPI trial period or documented intolerance/allergy will be determined according to the local clinical standard of care.
Who cannot join
- Esophageal dilation within 8 weeks of the screening endoscopy.
- Inability to pass a standard upper endoscope (8-10mm) due to esophageal narrowing or stricturing.
- Swallowed/topical steroids for EoE within 4 weeks of the screening endoscopy, or a course of systemic corticosteroids within 8 weeks of the screening endoscopy.
- Not having maintained a stable diet for at least 6 weeks preceding the screening endoscopy.
- Initiation, discontinuation, or change of dose regimen of PPIs; leukotriene inhibitors; or nasal, inhaled, and/or orally administered topical corticosteroids for any condition (such as gastroesophageal reflux disease, asthma, or allergic rhinitis) within the 8 weeks prior to the qualifying esophagogastroduodenoscopy (EGD).
- Presence of concomitant eosinophilic gastritis (EG), eosinophilic gastroenteritis (EGE), eosinophilic colitis (EC), Crohn's disease, ulcerative colitis, or celiac disease.
Show all 16Show fewer
- History of malignancy within 5 years prior to screening, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
- History of achalasia.
- Prior esophageal surgery.
- History of bleeding disorder or esophageal varices.
- Active parasitic infection or suspicion of an active parasitic infection, which, in the opinion of the site-Investigator, has not been previously evaluated or treated. Subjects presenting with signs of active parasitic infection or suspicion of active parasitic infection as assessed by current diarrhea and/or blood or mucus in stool will be referred to their clinical physician for further testing to rule out parasitic infection.
- Any other active infections judged at the discretion of the site-Investigator.
- Any other medical or psychological condition that, in the opinion of the site-investigator, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents.
- Patient or his/her immediate family is a member of the investigational team.
- Pregnancy or breastfeeding.
- Women of children bearing potential who are not on highly-effective contraception.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
MNGI Digestive Health, P.A.
Minneapolis, Minnesota, 55446
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms
Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.
Read the detailed description
This is a multi-center, randomized, double blind, parallel-arm, placebo controlled trial of mepolizumab. After the first 3 month blinded phase, there will be a second 3 month blinded phase where all patients receive active medication, but the dose will be lower in the subjects initially randomized to the placebo arm.
In the first arm, subjects will receive mepolizumab 300 mg SQ monthly for 3 months. In the second arm, subjects will receive a placebo SQ injection monthly for 3 months. Both groups will have the injection administered under direct observation in a Clinical \& Translational Research Center (CTRC) or other clinic to ensure proper administration and compliance. Each visit will also provide an opportunity for symptom questionnaires to be completed and for blood samples to be drawn. After 3 months (the time point where the primary outcome is assessed), all subjects initially randomized to active treatment will continue with mepolizumab dosing 300 mg SQ monthly, and will remain blinded. All subjects initially randomized to placebo will receive mepolizumab 100mg SQ monthly, and will remain blinded. Of note, no dietary changes, changes in baseline Proton Pump Inhibitor (PPI) medication dose, changes in inhaled or intranasal steroid doses, or administration or oral, topical/swallowed, or systemic steroids will be allowed during the study period. Subjects will undergo endoscopy after the first blinded phase (at 3 months) and after the second blinded phase (after 6 months).
- Conditions
- EoE, Eosinophilic Esophagitis
- Being tested
- Mepolizumab 300 mg, Mepolizumab 100 mg, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab 300 mgDrug
Also called Nucala
Mepolizumab 300 mg subcutaneous injection
Mepolizumab 100 mgDrug
Also called Nucala
Mepolizumab 100 mg subcutaneous injection
PlaceboOther
Also called Saline
Saline subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab 300 mg | Experimental | Subjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months Receives: Drug: Mepolizumab 300 mg |
| Placebo, followed by Mepolizumab 100 mg | Other | This arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding. Receives: Drug: Mepolizumab 100 mg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Dysphagia Score
Dysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Measured: Baseline, Month 3 Post-Treatment
Secondary outcomes (6)
Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)
The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Measured: After 3 months of treatment
Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)
The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Measured: After 3 months of treatment
Absolute Peak Eosinophil Count
Absolute peak eosinophil (EOS) count (measured in EOS/hpf) after 3 months of treatment.
Measured: After 3 months of treatment
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field
Number of participants with a histologic response as assessed by having <15, ≤ 6, and ≤ 1 Eosinophils per high powered field (EOS/hpf).
Measured: After 3 months of treatment
Mean Change in Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
Mean change in severity of endoscopic findings as measured by the EoE (Eosinophilic Esophagitis) Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema as absent (0) or present (1); furrows as absent (0), mild (1), or severe (2); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
Measured: Baseline, 3 months post-treatment
Mean Change in the Straumann Dysphagia Instrument (SDI) Score
The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.
Measured: Baseline, 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start20 Mar 2019
- Primary completion6 Jun 2022
- Study completion9 Dec 2022
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 EoEStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, University of Utah, Northwestern University, MNGI Digestive Health, P.A.
- Responsible party
- Sponsor
- Investigators
- Evan S Dellon, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656380
- Sponsor's protocol ID
- 18-0431
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2018
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dellon ES, Peterson KA, Mitlyng BL, Iuga A, Bookhout CE, Cortright LM, Walker KB, Gee TS, McGee SJ, Cameron BA, Galanko JA, Woosley JT, Eluri S, Moist SE, Hirano I. Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial. Gut. 2023 Oct;72(10):1828-1837. doi: 10.1136/gutjnl-2023-330337. Epub 2023 Jul 9.
PubMed 37423717
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms
- ClinicalTrials.gov ID
- NCT03656380
- Acronym / sponsor ID
- 18-0431
- Conditions
- EoE, Eosinophilic Esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, University of Utah, Northwestern University, MNGI Digestive Health, P.A.
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 23 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, randomized, double blind, parallel-arm, placebo controlled trial to determine whether mepolizumab is more effective than placebo for improving symptoms of dysphagia and decreasing esophageal eosinophil counts in adults and adolescents with active eosinophilic esophagitis (EoE) after an initial 3 month treatment course, and will also assess the impact of an additional 3 months of treatment.
Detailed description
This is a multi-center, randomized, double blind, parallel-arm, placebo controlled trial of mepolizumab. After the first 3 month blinded phase, there will be a second 3 month blinded phase where all patients receive active medication, but the dose will be lower in the subjects initially randomized to the placebo arm.
In the first arm, subjects will receive mepolizumab 300 mg SQ monthly for 3 months. In the second arm, subjects will receive a placebo SQ injection monthly for 3 months. Both groups will have the injection administered under direct observation in a Clinical \& Translational Research Center (CTRC) or other clinic to ensure proper administration and compliance. Each visit will also provide an opportunity for symptom questionnaires to be completed and for blood samples to be drawn. After 3 months (the time point where the primary outcome is assessed), all subjects initially randomized to active treatment will continue with mepolizumab dosing 300 mg SQ monthly, and will remain blinded. All subjects initially randomized to placebo will receive mepolizumab 100mg SQ monthly, and will remain blinded. Of note, no dietary changes, changes in baseline Proton Pump Inhibitor (PPI) medication dose, changes in inhaled or intranasal steroid doses, or administration or oral, topical/swallowed, or systemic steroids will be allowed during the study period. Subjects will undergo endoscopy after the first blinded phase (at 3 months) and after the second blinded phase (after 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab 300 mg | Experimental | Drug: Mepolizumab 300 mgSubjects will receive Mepolizumab 300 mg subcutaneously (SQ) monthly for 6 months |
| Placebo, followed by Mepolizumab 100 mg | Other | Drug: Mepolizumab 100 mg, Other: PlaceboThis arm will receive placebo, followed by Mepolizumab 100 mg. Subjects will receive placebo subcutaneously (SQ) monthly for 3 months, followed by Mepolizumab 100 mg subcutaneously (SQ) monthly for 3 months. Mepolizumab will be administered with 2 SQ injections of placebo and 1 SQ injection of Mepolizumab 100 mg to maintain blinding. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age 16-75
- Diagnosis of EoE (eosinophilic esophagitis) as per consensus guidelines (including PPI non-response)*
- Active eosinophilia on esophageal biopsy, with a peak count of least 15 EOS/hpf (eosinophils per high power field) from at least one esophageal level.
- Biopsies from the stomach and duodenum that have ruled out alternative etiologies in all children and in adults with abnormal endoscopic findings or when other gastric or small intestinal conditions are clinical possibilities. If these samples have been obtained during a previous endoscopic evaluation and in the judgement of the site-Investigator the patient has not had a clinically significant change that would merit repeat gastric/duodenal biopsies, then prior normal gastric and duodenal biopsies are acceptable to exclude alternate etiologies.
- Active symptoms of dysphagia with more than 3 episodes of dysphagia over a period of 2 weeks during the screening period, and an Eosinophilic Esophagitis Symptom Activity Index (EEsAI; see below for details) score of ≥ 27 at baseline.
Key exclusion criteria (16 listed)
- Esophageal dilation within 8 weeks of the screening endoscopy.
- Inability to pass a standard upper endoscope (8-10mm) due to esophageal narrowing or stricturing.
- Swallowed/topical steroids for EoE within 4 weeks of the screening endoscopy, or a course of systemic corticosteroids within 8 weeks of the screening endoscopy.
- Not having maintained a stable diet for at least 6 weeks preceding the screening endoscopy.
- Initiation, discontinuation, or change of dose regimen of PPIs; leukotriene inhibitors; or nasal, inhaled, and/or orally administered topical corticosteroids for any condition (such as gastroesophageal reflux disease, asthma, or allergic rhinitis) within the 8 weeks prior to the qualifying esophagogastroduodenoscopy (EGD).
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 |
|---|---|---|
| Mepolizumab 300 mgAlso: NucalaMepolizumab 300 mg subcutaneous injection | Drug | Mepolizumab 300 mg |
| Mepolizumab 100 mgAlso: NucalaMepolizumab 100 mg subcutaneous injection | Drug | Placebo, followed by Mepolizumab 100 mg |
| PlaceboAlso: SalineSaline subcutaneous injection | Other | Placebo, followed by Mepolizumab 100 mg |
Primary outcome
Mean Change in Dysphagia Score
Time frame: Baseline, Month 3 Post-Treatment
Dysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
6 secondary outcomes
Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)
Time frame: After 3 months of treatment
Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)
Time frame: After 3 months of treatment
Absolute Peak Eosinophil Count
Time frame: After 3 months of treatment
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field
Time frame: After 3 months of treatment
Mean Change in Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
Time frame: Baseline, 3 months post-treatment
Mean Change in the Straumann Dysphagia Instrument (SDI) Score
Time frame: Baseline, 3 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37423717Dellon ES, Peterson KA, Mitlyng BL, Iuga A, Bookhout CE, Cortright LM, Walker KB, Gee TS, McGee SJ, Cameron BA, Galanko JA, Woosley JT, Eluri S, Moist SE, Hirano I. Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial. Gut. 2023 Oct;72(10):1828-1837. doi: 10.1136/gutjnl-2023-330337. Epub 2023 Jul 9.
- Individual participant dataSharing planned: No
Related trials for EoE
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up
Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a
Active, not recruitingPhase 2
A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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.
Evan S Dellon, MD, MPH principal investigator
UNC Chapel Hill
4 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 Mepolizumab 300 mg and Mepolizumab 100 mg in people with EoE and Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 4 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 10 inclusion and 16 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 23 Jun 2023). 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?
Mean Change in Dysphagia Score (time frame: Baseline, Month 3 Post-Treatment). 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 NCT03656380, 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 23 Aug 2023.