Hereditary AngioedemaPhase 2RAPIDe-1NCT04618211
Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
A Phase 2 study testing Deucrictibant in people with Hereditary Angioedema and Hereditary Angioedema Type I, run by Pharvaris Netherlands B.V. at 36 sites in 13 countries.
Trial summary
This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II
- What is being tested?
- Deucrictibant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 36 sitesin 13 countries
- Study dates
- 3 Feb 2021to 1 Mar 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Diagnosis of HAE type I or II
- Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening
- Reliable access and experience to use standard of care acute attack medications
Who cannot join
- Pregnancy or breast-feeding
- Clinically significant abnormal electrocardiogram
- Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
- Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment
- Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus
- Abnormal hepatic function
Show all 10Show fewer
- Abnormal renal function
- History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
- History of documented severe hypersensitivity to any medicinal product
- Participation in any other investigational drug study within defined period
Trial locations and contacts
36 sites in 13 countries.
36 sites in 13 countries
United States8 sites
Study site
Birmingham, Alabama, 35209
Study site
Chevy Chase, Maryland, 20815
Study site
Hershey, Pennsylvania, 17033
Study site
Paradise Valley, Arizona, 85253
Study site
San Diego, California, 92122
Study site
Santa Monica, California, 90404
Study site
St Louis, Missouri, 63141
Study site
Walnut Creek, California, 94598
Canada5 sites
Study site
Edmonton, Alberta
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Québec, Quebec
Study site
Toronto, Ontario
Germany5 sites
Study site
Berlin
Study site
Dresden
Study site
Frankfurt
Study site
Mainz
Study site
Ulm
About this study
Official title: A Phase II, Double-blind, Placebo-controlled, Randomized, Cross-over, Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-inhibitor Deficiency Type I and II
This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.
Read the detailed description
In Part I of the study, patients in non-attack state receive the assigned active single dose of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. In Part II of the study, patients self-administer blinded study drug at home to treat three HAE attacks with deucrictibant or placebo (cross-over).
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II, Hereditary Angioedema Attack, Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
- Being tested
- Deucrictibant, Placebo
- Keywords
- HAE, HAE Type I, HAE Type II, Oral Treatment, Bradykinin B2 Receptor Antagonists, PHVS416, PHA121, PHA-022121, Deucrictibant
- Medical subject headings
- Angioedemas, Hereditary, Hereditary Angioedema Types I and II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucrictibantDrug
Also called PHA-022121, PHA121, PHVS416
deucrictibant soft capsules for oral use
PlaceboDrug
Matching placebo capsules for oral use
| Study group | Role | What they receive |
|---|---|---|
| Low dose/placebo | Other | Single low dose of deucrictibant or placebo Receives: Drug: Deucrictibant; Drug: Placebo |
| Medium dose/placebo | Other | Single medium dose of deucrictibant or placebo Receives: Drug: Deucrictibant; Drug: Placebo |
| High dose/placebo | Other | Single high dose of deucrictibant or placebo Receives: Drug: Deucrictibant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment
The primary endpoint of the study was the change of the VAS-3 (3-symptom composite visual analogue scale) score from pre-treatment to 4 hours post-treatment. The VAS-3 was calculated as the mean of the VAS scores of the 3 major HAE symptoms: skin swelling, skin pain, and abdominal pain. The VAS scores of the 3 major HAE symptoms (skin swelling, skin pain, and abdominal pain) could range between 0 (No swelling/No pain) and 100 (Extreme swelling/Excruciating pain)
Measured: Assessed from pre-treatment to 4 hours post-treatment
Secondary outcomes (19)
Time to Onset of Symptom Relief by ≥30% Reduction in Visual Analogue Scale (VAS-3) Composite Score From the Pre-treatment Score
VAS-3 scores range between 0 and 100.
Measured: Assessed from pre-treatment to 48-hours post-treatment
Time to Onset of Almost Complete or Complete Symptom Relief by Visual Analogue Scale (VAS-3)
VAS scores range between 0 and 100. Almost complete symptom relief is defined as all 3 individual VAS scores of the VAS-3 having a value < 10. Complete symptom relief is defined as all 3 individual VAS scores are of the VAS-3 having a value of 0.
Measured: Assessed from pre-treatment to 48 hours post-treatment
Time to a ≥50% Reduction in VAS-3 Composite Score From the Pre-treatment Score
Time to a ≥50% reduction in VAS-3 composite score from the pre-treatment score.
Measured: Assessed from pre-treatment to 48 hours post-treatment
Change in the Mean Symptom Complex Severity (MSCS) Score From Pre-treatment to 4 Hours Post-treatment
MSCS scores range between 0 and 3. A higher score means a worse outcome.
Measured: Pre-treatment and 4 hours post-treatment
Treatment Outcome Score (TOS) at 4 Hours Post-treatment
TOS range between -100 and 100. A positive score indicates improvement, a score of 0 indicates no change, and a negative score indicates worsening compared to pre-treatment.
Measured: 4 hours post-treatment
Time to Onset of Primary Symptom Relief Assessed by a 30% Reduction in the VAS for the Primary Symptom
Time to onset of primary symptom relief assessed by a 30% reduction in the VAS for the primary symptom within 48 hours post-treatment
Measured: Within 48 hours post-treatment
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 12 Hours.
Proportion of blinded study drug treated attacks requiring HAE rescue medication within 12 hours post-treatment.
Measured: Assessed at 12 hours post study drug treatment
Time to First HAE Rescue Medication Use for Study Drug-treated Attacks Within 48 Hours Post-treatment
The proportion of treated attacks with first use of HAE rescue medication within 48 hours post-treatment with PHA-022121.
Measured: Assessed at 48 hours post study drug treatment
Time to Change in the VAS Score for Skin Pain Score - 30% Reduction
Time to change in the VAS score for Skin Pain Score - 30% reduction within 48-hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.
Measured: Within 48 hours post treatment
Change in Mean Symptom Complex Severity Score From Pre-treatment to 24 Hours Post-treatment
Change in the Mean Symptom Complex Severity (MSCS) score from pre-treatment to 24 hours post-treatment. A lower MSCS score indicates a better outcome.
Measured: 24 hours post-treatment
TOS at 24 Hours Post-treatment
Treatment outcome score at 24 hours post-treatment. A higher score indicates improvement.
Measured: Assessed within 24 hours post treatment
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Effectiveness Domain Score
MMRM analysis of Treatment Satisfaction Questionnaire for Medication (TSQM) at 48 hours post-treatment. The 11-item TSQM (version II) evaluated participant treatment satisfaction with the medication for the following scales: effectiveness, side effects, convenience, and overall satisfaction Scale scores were transformed into scores ranging from 0 to 100 and could be used to calculate a total composite score, a higher score indicating greater satisfaction.
Measured: 48 hours post-treatment
Time to Onset of Primary Symptom Relief by 50% Reduction in VAS Score
Time to Onset of Primary Symptom Relief by 50% Reduction in VAS Score within 48 hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.
Measured: Within 48 hours post-treatment
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 24 Hours.
Qualifying attacks treated with study drug may use approved rescue medication if no symptom relief within 4 hours has been experienced.
Measured: Assessed at 24 hours post-study drug treatment
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 48 Hours
Qualifying attacks treated with study drug may use approved rescue medication if no symptom relief within 4 hours has been experienced.
Measured: Assessed at 48 hours post-study drug treatment
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Convenience Domain Score
MMRM analysis of Treatment Satisfaction Questionnaire for Medication (TSQM) at 48 hours post-treatment. The 11-item TSQM (version II) evaluated participant treatment satisfaction with the medication for the following scales: effectiveness, side effects, convenience, and overall satisfaction Scale scores were transformed into scores ranging from 0 to 100 and could be used to calculate a total composite score, a higher score indicating greater satisfaction.
Measured: 48 hours post-treatment
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Satisfaction Domain Score
MMRM analysis of Treatment Satisfaction Questionnaire for Medication (TSQM) at 48 hours post-treatment. The 11-item TSQM (version II) evaluated participant treatment satisfaction with the medication for the following scales: effectiveness, side effects, convenience, and overall satisfaction Scale scores were transformed into scores ranging from 0 to 100 and could be used to calculate a total composite score, a higher score indicating greater satisfaction.
Measured: 48 hours post-treatment
Time to Change in the VAS Score for Skin Swelling Score - 30% Reduction
Time to change in the VAS score for Skin Swelling Score - 30% reduction within 48 hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.
Measured: Within 48 hours post-treatment
Time to Change in the VAS Score for Abdominal Pain Score - 30% Reduction
Time to change in the VAS score for Abdominal Pain Score - 30% reduction within 48 hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.
Measured: Within 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start3 Feb 2021
- Primary completion23 Sep 2022
- Study completion1 Mar 2023
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 Hereditary AngioedemaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharvaris Netherlands B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Maurer, Prof MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618211
- Sponsor's protocol ID
- PHA022121-C201
- Other IDs
- 2020-003445-11
- Acronym
- RAPIDe-1
- Status last verified
- Dec 2025
- First submitted
- 26 Oct 2020
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maurer M, Stobiecki M, Valerieva A, Hakl R, Staevska MT, Bouillet L, Du-Thanh A, Kessel A, Kiani-Alikhan S, Magerl M, Reshef A, Baeza ML, Fain O, Farkas H, Greve J, Guilarte M, Jacobs JS, Li HH, Lleonart R, Manning ME, Sussman GL, Anderson J, Chapdelaine H, Cohn DM, Hagin D, Kralickova P, Ritchie B, Spadaro G, Staubach P, Tarzi MD, Yang WH, Jouvin MH, Crabbe R, van Leeuwen S, Chen H, Zhu L, Knolle J, Lesage A, Lu P, Riedl MA, Aygoren-Pursun E. Oral deucrictibant for on-demand treatment of hereditary angioedema attacks (RAPIDe-1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Haematol. 2026 Apr;13(4):e200-e214. doi: 10.1016/S2352-3026(25)00341-2. Epub 2026 Mar 19.
PubMed 41865747
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Placebo-controlled, Randomized, Cross-over, Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-inhibitor Deficiency Type I and II
- ClinicalTrials.gov ID
- NCT04618211
- Acronym / sponsor ID
- RAPIDe-1 / PHA022121-C201
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II, Hereditary Angioedema Attack, Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
- Keywords
- HAE, HAE Type I, HAE Type II, Oral Treatment, Bradykinin B2 Receptor Antagonists, PHVS416, PHA121, PHA-022121
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pharvaris Netherlands B.V.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.
Detailed description
In Part I of the study, patients in non-attack state receive the assigned active single dose of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. In Part II of the study, patients self-administer blinded study drug at home to treat three HAE attacks with deucrictibant or placebo (cross-over).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose/placebo | Other | Drug: Deucrictibant, Drug: PlaceboSingle low dose of deucrictibant or placebo |
| Medium dose/placebo | Other | Drug: Deucrictibant, Drug: PlaceboSingle medium dose of deucrictibant or placebo |
| High dose/placebo | Other | Drug: Deucrictibant, Drug: PlaceboSingle high dose of deucrictibant or placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent form
- Diagnosis of HAE type I or II
- Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening
- Reliable access and experience to use standard of care acute attack medications
Key exclusion criteria (10 listed)
- Pregnancy or breast-feeding
- Clinically significant abnormal electrocardiogram
- Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
- Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment
- Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus
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 |
|---|---|---|
| DeucrictibantAlso: PHA-022121, PHA121, PHVS416deucrictibant soft capsules for oral use | Drug | High dose/placebo, Low dose/placebo, Medium dose/placebo |
| PlaceboMatching placebo capsules for oral use | Drug | High dose/placebo, Low dose/placebo, Medium dose/placebo |
Primary outcome
Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment
Time frame: Assessed from pre-treatment to 4 hours post-treatment
The primary endpoint of the study was the change of the VAS-3 (3-symptom composite visual analogue scale) score from pre-treatment to 4 hours post-treatment. The VAS-3 was calculated as the mean of the VAS scores of the 3 major HAE symptoms: skin swelling, skin pain, and abdominal pain. The VAS scores of the 3 major HAE symptoms (skin swelling, skin pain, and abdominal pain) could range between 0 (No swelling/No pain) and 100 (Extreme swelling/Excruciating pain)
19 secondary outcomes
Time to Onset of Symptom Relief by ≥30% Reduction in Visual Analogue Scale (VAS-3) Composite Score From the Pre-treatment Score
Time frame: Assessed from pre-treatment to 48-hours post-treatment
Time to Onset of Almost Complete or Complete Symptom Relief by Visual Analogue Scale (VAS-3)
Time frame: Assessed from pre-treatment to 48 hours post-treatment
Time to a ≥50% Reduction in VAS-3 Composite Score From the Pre-treatment Score
Time frame: Assessed from pre-treatment to 48 hours post-treatment
Change in the Mean Symptom Complex Severity (MSCS) Score From Pre-treatment to 4 Hours Post-treatment
Time frame: Pre-treatment and 4 hours post-treatment
Treatment Outcome Score (TOS) at 4 Hours Post-treatment
Time frame: 4 hours post-treatment
Time to Onset of Primary Symptom Relief Assessed by a 30% Reduction in the VAS for the Primary Symptom
Time frame: Within 48 hours post-treatment
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 12 Hours.
Time frame: Assessed at 12 hours post study drug treatment
Time to First HAE Rescue Medication Use for Study Drug-treated Attacks Within 48 Hours Post-treatment
Time frame: Assessed at 48 hours post study drug treatment
Time to Change in the VAS Score for Skin Pain Score - 30% Reduction
Time frame: Within 48 hours post treatment
Change in Mean Symptom Complex Severity Score From Pre-treatment to 24 Hours Post-treatment
Time frame: 24 hours post-treatment
TOS at 24 Hours Post-treatment
Time frame: Assessed within 24 hours post treatment
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Effectiveness Domain Score
Time frame: 48 hours post-treatment
Time to Onset of Primary Symptom Relief by 50% Reduction in VAS Score
Time frame: Within 48 hours post-treatment
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 24 Hours.
Time frame: Assessed at 24 hours post-study drug treatment
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 48 Hours
Time frame: Assessed at 48 hours post-study drug treatment
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Convenience Domain Score
Time frame: 48 hours post-treatment
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Satisfaction Domain Score
Time frame: 48 hours post-treatment
Time to Change in the VAS Score for Skin Swelling Score - 30% Reduction
Time frame: Within 48 hours post-treatment
Time to Change in the VAS Score for Abdominal Pain Score - 30% Reduction
Time frame: Within 48 hours post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41865747Maurer M, Stobiecki M, Valerieva A, Hakl R, Staevska MT, Bouillet L, Du-Thanh A, Kessel A, Kiani-Alikhan S, Magerl M, Reshef A, Baeza ML, Fain O, Farkas H, Greve J, Guilarte M, Jacobs JS, Li HH, Lleonart R, Manning ME, Sussman GL, Anderson J, Chapdelaine H, Cohn DM, Hagin D, Kralickova P, Ritchie B, Spadaro G, Staubach P, Tarzi MD, Yang WH, Jouvin MH, Crabbe R, van Leeuwen S, Chen H, Zhu L, Knolle J, Lesage A, Lu P, Riedl MA, Aygoren-Pursun E. Oral deucrictibant for on-demand treatment of hereditary angioedema attacks (RAPIDe-1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Haematol. 2026 Apr;13(4):e200-e214. doi: 10.1016/S2352-3026(25)00341-2. Epub 2026 Mar 19.
- 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.
Marcus Maurer, Prof MD principal investigator
Charite University, Berlin, Germany
36 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deucrictibant in people with Hereditary Angioedema and Hereditary Angioedema Type I, run by Pharvaris Netherlands B.V. at 36 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada, Germany, France, Israel and 8 more countries. 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 17 Dec 2025). 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 of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment (time frame: Assessed from pre-treatment to 4 hours 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 NCT04618211, 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 17 Dec 2025.