Behcet DiseasePhase 2BehcetNCT02756650
1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement
A Phase 2 study testing Canakinumab in people with Behcet Disease, run by Novartis Pharmaceuticals at 1 site in Turkey (Türkiye).
Trial summary
Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Behcet Disease
- What is being tested?
- Canakinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2016to 31 Jan 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged over 18-60 Behced Disease fulfilling the International Study Group (ISG) criteria, who have a recent exacerbation of large-vessel vascular disease and/or parenchymal neurologic disease For Neurologic Involvement
- Patients experiencing an acute exacerbation of parenchymal neurologic disease involving brainstem and/or diencephalic region.
- Exacerbation is defined based on the presence of both of the following:
- An acute/subacute neurological syndrome including any of hemiparesis, ataxia, dysarthria,headache within the first month of onset of neurologic manifestations (without any prior high dose steroid treatment)
- Compatible cranial MRI lesion involving brainstem and/or diencephalic region
- For Vascular Disease :
Show all 10Show fewer
- Patients experiencing an acute exacerbation of vascular disease within the last month, involving
- Large arteries (abdominal aorta, pulmonary arteries, extremity arteries)
- Large veins (deep vein thrombosis of extremities, caval vein thrombosis, dural sinus thrombosis)
- Compatible radiological findings (spiral CT, MR, or Doppler ultrasonography)
Who cannot join
- For Neurologic Involvement :
- Presence of severe neurological sequelae from any previous attacks rendering the patient dependent on others physically or mentally
- Any other neurological cause underlying the picture including ischemic central nervous system lesion on MRI
- Any previous treatment with biological agents other than interferon-alpha or any previous treatment with cyclophosphamide
- No interferon in the last 6 months, no Intra Venous Metilprednizolon in the past month
- For Vascular disease and general :
Show all 18Show fewer
- Presence of severe vascular sequelae from any previous attacks rendering the patient dependent on others
- Any other vascular disease complication the evaluation of exacerbation
- Any previous treatment with biological agents other than interferon alpha, or any previous treatment with cyclophosphamide
- No interferon alpha in the last 6 months, no IVMP in the past month
- History of Squamo Cell Carcinoma OR Basal Cell Carcinoma in previous 5 years. General
- Presence or history of any other inflammatory rheumatic disease
- Positive Purified Protein Derivative test (according to local guidance) where an active Tuberculosis infection cannot be excluded via Quantiferon (T-Spot or radiographic imaging if needed) Pregnancy or lactation
- Presence of any active or chronic infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral antibiotics within 14 days prior to screening
- History or a malignancy within the last 5 years, except for successfully excised squamous or basal cell carcinoma of the skin
- Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding
- With known sensitivity to canakinumab
- Use of any other investigational agent in the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular Involvement
Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.
Read the detailed description
Primary endpoint: Resolution of acute exacerbation findings related to Behçet's Disease (BD) based on achievements in any of the following items without deterioration on day 30:
For patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30:
- Improvement of muscle strength, ataxia, or other relevant neurologic findings depending on the involved region on neurological examination (by Neuro-Behçet's Disease Score, Modified Expanded Disability Status Scale, and Modified Rankin Scores) cerebrospinal fluid
- Improvement in systemic inflammatory findings (CRP, Erythrocyte Sedimentation Rate , SAA)
- Any decrease in the size of the MRI lesion, or disappearance of contrast enhancement
- Improvement in patients' and physicians global assessment using a 10-cm visual analogue scale (VAS)
Complete response was defined as full clinical recovery to the pre-attack state, disappearance of MRI lesion(s), and normalisation of Cerebrospinal Fluid findings.
Partial response was defined as partial improvement in clinical findings, but with findings still worse than the pre-attack state, and MRI lesions, which become smaller with no or less enhancement, and a decrease in cerebrospinal fluid cell count.
Non-response was defined as no improvement in clinical findings, no change on MRI, no change in cerebrospinal fluid parameters, or worsening in those findings.
For patients with large vessel vascular disease: Resolution of acute vascular exacerbation findings related to Behçet's Disease based on achievements in any of the following items without deterioration at 1 month:
- Improvement in relevant symptoms (localised pain, abdominal pain, calf thickness, haemoptysis) by using physician and patient's global assessment with VAS
- Improvement in systemic inflammatory findings (CRP, ESR, SAA)
- Any improvement in radiological findings depending on the involved vessels (MR, CT or Doppler findings)
- Improvement in patients' and physicians global assessment using a 10-cm visual analogue scale (VAS)
Complete response was defined as clinical and laboratory improvement based on ≥50% improvements in patient's and physician's global assessments by using VAS, and ≥50% reduction in CRP values; along with stable or ≥20% reduced aneurysm size in patients with arterial involvement, and stable or ≥20% reduced calf swelling in patients with lower extremity venous thrombosis.
Partial response was defined as clinical and laboratory improvement based on observations of an improvement between 20-49% according to patient's and physician's global assessments by using VAS, 20-49% reduction in CRP values; along with stable or less than 20% reduced aneurysm size in patients with arterial involvement, and stable or less than 20% reduced calf swelling in patients with lower extremity thrombosis.
Non-response will be defined as observing no or less than 20% clinical improvement by patient's and physician's global VAS or worsening of clinical findings, no change or increase in acute phase response, increase in aneurysm size for patients with arterial involvement or progression of venous thrombosis in patients with venous involvement.
- Conditions
- Behcet Disease
- Being tested
- Canakinumab
- Keywords
- Behcet Disease, Inflammation, Immune system, Arthritis
- Medical subject headings
- Behcet Syndrome, Inflammation, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ACZ885
150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab | Experimental | Canakinumab was administered monthly Receives: Drug: Canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Attacks
Resolution of acute exacerbation findings related to Behçet's Disease (BD). The attacks were assessed by pyhsician global assesment.
For patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30
This was an exploratory trial that was not powered for a statistical analysis.
Measured: 30 days
Modified Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Scale range is between 0-10 with 10 being most disability. Mean score of 3 participants who were evaluated in Neurology clinic. Other 5 participants were not evaluated for EDSS.
Measured: 30 days
Neuro-Behçet's Disability Score (NBDS)
Neuro-Behçet's disability score (NBDS) has been proposed for parenchymal-NBD patients to quantify disabilities. This comprises scores for motor and cognitive status. NBDS is the arithmetic sum of both scores and ranges from 0 to 8, with 8 being death due to NBD. 3 neurologic participants were evaluated.
Measured: 30 days
Modified Ranking Score (mRS)
Mean Modified Rankin Scale (mRS): mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-5 with 5 being the worst outcome. Only 3 participants from neurology clinic were evaluated with this scale.
Measured: 30 days
Ataxia
Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.
Measured: 30 days
Physical Examination Scores Indicating Change in Muscle Strength
All 4 extremties were evaluated for muscle strength (upper right, upper left, lower right and lower left) fro each patient. Score 0 is the worst outcome whereas 5 is the best outcome for muscle strength. 3 participants from neurology clinic were assessed.
Measured: 30 days
C-reactive Protein (CRP) Values
Mean CRP (C-reactive protein) value (8 participants)
Measured: 30 days
Erythrocyte Sedimentation Rate (ESR)
Mean erythrocyte sedimentation rate (ESR) value (8 participants)
Measured: 30 days
SAA (Serum Amyloid A)
Mean Serum Amyloid A value (8 participants)
Measured: 30 days
Hemoptysis
The number of the participants with hemoptysis
Measured: 30 days
Visual Analogue Scores (VAS) for Headache
Headache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. Physician and participant determined the VAS score separately.
Measured: 30 days
Visual Analogue Scores (VAS) for Stomachache
Stomacheache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. VAS is determined separately by physician and the participants.
Measured: 30 days
Visual Analogue Scores (VAS) for Extremity Assessments
Extremity assessments were measured by VAS where score 0 means "no pain," and score 10 means "the worst possible pain''. The physicians and participants evaluated VAS separately.
Measured: 30 days
Visual Analogue Scores (VAS) for Patients' General Assessments
Participants assessed their own well-being with VAS (visual analogue scale). Score 0 means the best outcome, score 10 is the worst outcome.
Measured: 30 days
Physician's Global Assessment
Physician's General Assessments is VAS scale, ranging between 0-5, showing the disease status of participants. Score 0 is the worst outcome; 5 is the best outcome
Measured: 30 days
Steroid Dose Regimen
Mean steroid treatment dose (8 participants)
Measured: 30 days
BDCAF (Behçet's Disease Current Activity Form)
BDCAF is an assessment that is made by physician for evaluating the disease activity in last four weeks. Score range is 0 to 12, 0 is the best outcome, 12 is the worst outcome.
Measured: 30 days
Extremity (Localized) Pain Assessment (VAS)
Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start23 Jun 2016
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behcet DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmet Gül, Prof, Study chair, IU Faculty of MedicineMurat Kurtuncu, Ass.Prof, Principal investigator, IU Faculty of MedicineGulsen Akman Demir, Prof, Principal investigator, Bilim University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756650
- Sponsor's protocol ID
- CACZ885NTR01
- Acronym
- Behcet
- Status last verified
- May 2020
- First submitted
- 31 Mar 2016
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular Involvement
- ClinicalTrials.gov ID
- NCT02756650
- Acronym / sponsor ID
- Behcet / CACZ885NTR01
- Conditions
- Behcet Disease
- Keywords
- Behcet Disease, Inflammation, Immune system, Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.
Detailed description
Primary endpoint: Resolution of acute exacerbation findings related to Behçet's Disease (BD) based on achievements in any of the following items without deterioration on day 30:
For patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30:
- Improvement of muscle strength, ataxia, or other relevant neurologic findings depending on the involved region on neurological examination (by Neuro-Behçet's Disease Score, Modified Expanded Disability Status Scale, and Modified Rankin Scores) cerebrospinal fluid
- Improvement in systemic inflammatory findings (CRP, Erythrocyte Sedimentation Rate , SAA)
- Any decrease in the size of the MRI lesion, or disappearance of contrast enhancement
- Improvement in patients' and physicians global assessment using a 10-cm visual analogue scale (VAS)
Complete response was defined as full clinical recovery to the pre-attack state, disappearance of MRI lesion(s), and normalisation of Cerebrospinal Fluid findings.
Partial response was defined as partial improvement in clinical findings, but with findings still worse than the pre-attack state, and MRI lesions, which become smaller with no or less enhancement, and a decrease in cerebrospinal fluid cell count.
Non-response was defined as no improvement in clinical findings, no change on MRI, no change in cerebrospinal fluid parameters, or worsening in those findings.
For patients with large vessel vascular disease: Resolution of acute vascular exacerbation findings related to Behçet's Disease based on achievements in any of the following items without deterioration at 1 month:
- Improvement in relevant symptoms (localised pain, abdominal pain, calf thickness, haemoptysis) by using physician and patient's global assessment with VAS
- Improvement in systemic inflammatory findings (CRP, ESR, SAA)
- Any improvement in radiological findings depending on the involved vessels (MR, CT or Doppler findings)
- Improvement in patients' and physicians global assessment using a 10-cm visual analogue scale (VAS)
Complete response was defined as clinical and laboratory improvement based on ≥50% improvements in patient's and physician's global assessments by using VAS, and ≥50% reduction in CRP values; along with stable or ≥20% reduced aneurysm size in patients with arterial involvement, and stable or ≥20% reduced calf swelling in patients with lower extremity venous thrombosis.
Partial response was defined as clinical and laboratory improvement based on observations of an improvement between 20-49% according to patient's and physician's global assessments by using VAS, 20-49% reduction in CRP values; along with stable or less than 20% reduced aneurysm size in patients with arterial involvement, and stable or less than 20% reduced calf swelling in patients with lower extremity thrombosis.
Non-response will be defined as observing no or less than 20% clinical improvement by patient's and physician's global VAS or worsening of clinical findings, no change or increase in acute phase response, increase in aneurysm size for patients with arterial involvement or progression of venous thrombosis in patients with venous involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canakinumab | Experimental | Drug: CanakinumabCanakinumab was administered monthly |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients aged over 18-60 Behced Disease fulfilling the International Study Group (ISG) criteria, who have a recent exacerbation of large-vessel vascular disease and/or parenchymal neurologic disease For Neurologic Involvement
- Patients experiencing an acute exacerbation of parenchymal neurologic disease involving brainstem and/or diencephalic region.
- Exacerbation is defined based on the presence of both of the following:
- An acute/subacute neurological syndrome including any of hemiparesis, ataxia, dysarthria,headache within the first month of onset of neurologic manifestations (without any prior high dose steroid treatment)
- Compatible cranial MRI lesion involving brainstem and/or diencephalic region
Key exclusion criteria (18 listed)
- Presence of severe neurological sequelae from any previous attacks rendering the patient dependent on others physically or mentally
- Any other neurological cause underlying the picture including ischemic central nervous system lesion on MRI
- Any previous treatment with biological agents other than interferon-alpha or any previous treatment with cyclophosphamide
- No interferon in the last 6 months, no Intra Venous Metilprednizolon in the past month
- Presence of severe vascular sequelae from any previous attacks rendering the patient dependent on others
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 |
|---|---|---|
| CanakinumabAlso: ACZ885150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6) | Drug | Canakinumab |
Primary outcome
Number of Participants With Attacks
Time frame: 30 days
Resolution of acute exacerbation findings related to Behçet's Disease (BD). The attacks were assessed by pyhsician global assesment. For patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30 This was an exploratory trial that was not powered for a statistical analysis.
Modified Expanded Disability Status Scale (EDSS)
Time frame: 30 days
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Scale range is between 0-10 with 10 being most disability. Mean score of 3 participants who were evaluated in Neurology clinic. Other 5 participants were not evaluated for EDSS.
Neuro-Behçet's Disability Score (NBDS)
Time frame: 30 days
Neuro-Behçet's disability score (NBDS) has been proposed for parenchymal-NBD patients to quantify disabilities. This comprises scores for motor and cognitive status. NBDS is the arithmetic sum of both scores and ranges from 0 to 8, with 8 being death due to NBD. 3 neurologic participants were evaluated.
Modified Ranking Score (mRS)
Time frame: 30 days
Mean Modified Rankin Scale (mRS): mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-5 with 5 being the worst outcome. Only 3 participants from neurology clinic were evaluated with this scale.
Ataxia
Time frame: 30 days
Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.
Physical Examination Scores Indicating Change in Muscle Strength
Time frame: 30 days
All 4 extremties were evaluated for muscle strength (upper right, upper left, lower right and lower left) fro each patient. Score 0 is the worst outcome whereas 5 is the best outcome for muscle strength. 3 participants from neurology clinic were assessed.
C-reactive Protein (CRP) Values
Time frame: 30 days
Mean CRP (C-reactive protein) value (8 participants)
Erythrocyte Sedimentation Rate (ESR)
Time frame: 30 days
Mean erythrocyte sedimentation rate (ESR) value (8 participants)
SAA (Serum Amyloid A)
Time frame: 30 days
Mean Serum Amyloid A value (8 participants)
Hemoptysis
Time frame: 30 days
The number of the participants with hemoptysis
Visual Analogue Scores (VAS) for Headache
Time frame: 30 days
Headache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. Physician and participant determined the VAS score separately.
Visual Analogue Scores (VAS) for Stomachache
Time frame: 30 days
Stomacheache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. VAS is determined separately by physician and the participants.
Visual Analogue Scores (VAS) for Extremity Assessments
Time frame: 30 days
Extremity assessments were measured by VAS where score 0 means "no pain," and score 10 means "the worst possible pain''. The physicians and participants evaluated VAS separately.
Visual Analogue Scores (VAS) for Patients' General Assessments
Time frame: 30 days
Participants assessed their own well-being with VAS (visual analogue scale). Score 0 means the best outcome, score 10 is the worst outcome.
Physician's Global Assessment
Time frame: 30 days
Physician's General Assessments is VAS scale, ranging between 0-5, showing the disease status of participants. Score 0 is the worst outcome; 5 is the best outcome
Steroid Dose Regimen
Time frame: 30 days
Mean steroid treatment dose (8 participants)
BDCAF (Behçet's Disease Current Activity Form)
Time frame: 30 days
BDCAF is an assessment that is made by physician for evaluating the disease activity in last four weeks. Score range is 0 to 12, 0 is the best outcome, 12 is the worst outcome.
Extremity (Localized) Pain Assessment (VAS)
Time frame: 30 days
Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Ahmet Gül, Prof study chair
IU Faculty of Medicine
Murat Kurtuncu, Ass.Prof principal investigator
IU Faculty of Medicine
Gulsen Akman Demir, Prof principal investigator
Bilim University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab in people with Behcet Disease, run by Novartis Pharmaceuticals at 1 site in Turkey (Türkiye).
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 18 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 11 Jun 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?
Number of Participants With Attacks (time frame: 30 days). The study lists 18 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 11 Jun 2020.