Amyotrophic Lateral SclerosisPhase 1ALSFUS003NCT07193953
Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS)
A Phase 1 study testing Next Generation Dome Helmet Focused Ultrasound, Intravenous immunoglobulin (IVIG), 10% solution for infusion and Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension in people with Amyotrophic Lateral Sclerosis and ALS, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The goal of this study is to evaluate the safety and feasibility of IVIg administration in conjunction with primary motor cortex BBB opening using the Next Generation Dome Helmet (NGDH) FUS in adult participants with ALS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS
- What is being tested?
- Next Generation Dome Helmet Focused Ultrasound, Intravenous immunoglobulin (IVIG), 10% solution for infusion and Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2025to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ALS as per the Gold Coast Criteria;
- Aged 18 years or older;
- Capable of providing informed consent and complying with study procedures;
- If taking Riluzole, on a stable dose for at least 4 weeks prior to Baseline;
- If taking Edaravone, on a stable dose of one completed cycle prior to Baseline;
- Respiratory Function Criterion:
Show all 10Show fewer
- Able to lie supine without BiPAP or breathing discomfort; OR
- Forced vital capacity or slow vital capacity ≥50% of the predicted value for sex, height and age, if available
- Able to communicate sensations during the Dome FUS procedure.
- Qualified fit for the anesthesia by an anesthesiologist, ASA I-III.
Who cannot join
- MRI findings:
- Active infection/inflammation
- Acute or chronic hemorrhages, specifically > 4 lobar microbleeds, and no siderosis or macrohemorrhages
- Tumor/space occupying lesion causing significant mass effect
- Meningeal enhancement
- Intracranial hypotension
Show all 44Show fewer
- More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- Clips or other metallic implanted objects in the skull or the brain, except shunts
- Significant cardiac disease or unstable hemodynamic status including:
- Documented myocardial infarction within six months of screening
- Unstable angina on medication
- Unstable or worsening congestive heart failure
- Left ventricular ejection fraction below the lower limit of normal
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Severe hypertension (diastolic BP > 100 on medication)
- Patient has right-to-left, bidirectional, or transient right-to-left cardiac shunts
- QT prolongation observed on screening ECG (QTc > 450 for men and > 470 for women)
- Uncontrolled hypertension (systolic > 150 and diastolic BP > 100 on medication)
- Patients should not take medications known to increase risk of hemorrhage (e.g., aspirin or class I and III anticoagulants) for at least 7 days prior to treatment or lumbar puncture; patients should not take Avastin for 30 days prior to treatment
- History of a bleeding disorder, coagulopathy or a history of spontaneous hemorrhage or use of anticoagulants, specifically recent thrombosis or stroke in past 3 months; abnormal coagulation profile (PLT < 100,00/μl), PT (> 14 sec) or PTT (> 36 sec), and INR > 1.3
- No more than 1 non-strategic lacune \<1.5 cm
- Known cerebral or systemic vasculopathy
- Significant depression and at potential risk of suicide
- Known sensitivity/allergy to gadolinium (an alternative product may be used) and DEFINITY®.
- Any contraindications to MRI scanning, including:
- Large participants not fitting comfortably into the scanner
- Difficulty lying supine and still for up to 3 hours in the MRI unit or claustrophobia
- Any contraindication to lumbar puncture for collection of cerebral spinal fluid, including:
- Intracranial hypotension
- Untreated, uncontrolled sleep apnea
- Impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73m2 or on dialysis.
- IVIg use in the previous 6 months.
- Live viral vaccination within the 30 days before study entry
- Currently, or in the last 3 months participated in a clinical trial delivering an investigational product or non-approved use of a drug or device or in any other type of medical research.
- Respiratory: chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area, patients with a history of drug allergies, uncontrolled asthma or hay fever, and multiple allergies where the benefit/risk of administering DEFINITY® is considered unfavorable by the study physicians in relation to the product monograph for DEFINITY®.
- Motor cortex atrophy deemed severe enough to limit targeting
- Previous major allergic or anaphylactic reaction to IVIg
- Known IgA deficiency with anti-IgA.
- Known frontotemporal dementia;
- Definitely or possibly pregnant (if applicable);
- Known auto-immune condition with or without neurological manifestations (e.g., multiple sclerosis (MS), systemic lupus erythematous (SLE), Rheumatoid arthritis).
- Current, planned or previous use of oral, intramuscular or intravenous steroid drugs (such as prednisone, prednisolone, dexamethasone, triamcinolone, methylprednisolone, oxandrolone, and others), immunosuppressant drugs (azathioprine, mycophenolate, tacrolimus, sirolimus, cyclophosphamide, and others) or NSAIDs (ibuprofen, naproxen, celecoxib, and others) in the past 30 days;
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Neuroinflammation With Enhanced Delivery of Intravenous Immunoglobulin to the Motor Cortex Using Next Generation Dome Helmet Focused Ultrasound in Amyotrophic Lateral Sclerosis: A Phase I, Open Label Trial
The goal of this study is to evaluate the safety and feasibility of IVIg administration in conjunction with primary motor cortex BBB opening using the Next Generation Dome Helmet (NGDH) FUS in adult participants with ALS.
Read the detailed description
This study is a prospective, single-arm, open-label, multiple-ascending dose (MAD), phase I trial to evaluate safety, feasibility, pharmacodynamics, and pharmacokinetics of enhanced delivery of IVIg 0.4 or 0.8g/kg to the primary motor cortex in 6 patients with ALS by using a single BBB opening procedure targeting the primary motor cortex in both brain hemispheres. Six participants will be enrolled in two sequential cohorts. The first cohort (n = 3) will receive 0.4g/kg of IVIg divided in two doses, while the second cohort (n = 3) will receive a 0.8g/kg of IVIg divided in two doses. In both cohorts, the second dose of IVIg will be accompanied by a single BBB opening procedure targeting the primary motor cortex in both brain hemispheres with focused ultrasound (FUS) using Next Generation Dome Helmet and intravenous microbubbles (DEFINITY®, Lantheus Medical Imaging Canada, Inc., Montreal, QC, Canada). This FUS procedure will occur during 2 weeks after the first dose administration. Follow-up visits will occur over the span of 24 weeks from the first dose.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Being tested
- Next Generation Dome Helmet Focused Ultrasound, Intravenous immunoglobulin (IVIG), 10% solution for infusion, Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
- Keywords
- ALS, Focused Ultrasound, Blood Brain Barrier Opening, Intravenous Immunoglobulin, Motor Neuron Disease
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Dome Helmet Focused UltrasoundDevice
Two doses of IVIg will be administered 2 weeks apart. The first dose at Week 0 will be a standalone administration. The second dose at Week 2 will be combined with Next Generation Dome Helmet (NGDH) Focused Ultrasound (FUS) blood brain barrier (BBB) opening.
Intravenous immunoglobulin (IVIG), 10% solution for infusionDrug
Two doses of IVIg will be administered 2 weeks apart. The first dose at Week 0 will be a standalone administration. The second dose at Week 2 will be combined with Next Generation Dome Helmet (NGDH) Focused Ultrasound (FUS) blood brain barrier (BBB) opening. Cohort I will receive 0.2g/kg of IVIg at each dose. Cohort II will receive 0.4g/kg of IVIg at each dose.
Privigen® IVIg comes in vials containing 10% active ingredient. It is supplied in 2.5 g (25 mL bottle), 5 g (50 mL bottle), 10 g (100 mL bottle), 20 g (200 mL bottle) or 40 g (400 mL bottle). The IVIg dose will be determined based on the patient's ideal body weight.
Definity® Vial for (Perflutren Lipid Microsphere) Injectable SuspensionDrug
DEFINITY® Perflutren Injectable Microbubbles is an ultrasound contrast imaging agent that will be used for blood brain barrier opening during focused ultrasound. These microbubbles will be injected during the focused ultrasound procedure on the day of the second IVIg dose.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Immunoglobulin Administration using Focused Ultrasound | Experimental | ALS patients will be assigned to receive Intravenous Immunoglobulin (IVIg) and DEFINITY® microbubbles. The first three enrolled patients will participate in the first cohort, receiving 0.4g/kg divided in two doses. After a preliminary safety assessment of the first cohort, the next three successfully screened patients will be enrolled in the second cohort, receiving 0.8g/kg divided in two doses. The second IVIg dose in each cohort will be administered in combination with Next Generation Dome Helmet (NGDH) focused ultrasound (FUS) to transiently open the blood-brain barrier and enhance IVIg delivery to the primary motor cortex. Receives: Device: Next Generation Dome Helmet Focused Ultrasound; Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion; Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of IVIg in patients with ALS
This will be assessed up through the incidence of drug-related adverse events, serious adverse events, and discontinuations due to adverse events after Intravenous Immunoglobulin (IVIg) administration.
Measured: During and after IVIg administration at Week 0 and Week 2 Day 1 until Week 24.
Safety of DEFINITY® microbubbles
This will be assessed up through the incidence of drug-related adverse events, serious adverse events, and discontinuations due to adverse events after DEFINITY® infusion during focused ultrasound (FUS) blood brain barrier (BBB) opening.
Measured: During and after DEFINITY® administration at Week 2 Day 1 until Week 24.
Feasibility of FUS BBB opening in the motor cortex
This will be measured as detectable gadolinium enhancement at the arm, leg and bulbar regions of the motor cortex bilaterally following FUS with posterior normalization.
Measured: During and after Week 2 Day 1 FUS BBB opening until Week 24.
Safety of FUS BBB opening in the motor cortex
Incidence of BBB opening-related and FUS-related adverse events, serious adverse events, incidence of asymptomatic or symptomatic radiologic complication, such as evidence of bleeding or swelling after FUS, incidence of electrographic complication, such as epileptiform discharges on EEG, or accelerated ALS disease progression, defined as ≥ 6-point decline in the ALSFRS-R scores from Baseline to week 8.
Measured: From up to 30 days before Week 0 to Week 24.
Secondary outcomes (2)
Neurofilament light chain (NfL) levels in blood plasma and cerebrospinal fluid
Change in concentration of serum neurofilaments from Baseline to Week 24
Measured: From up to 30 days before Week 0 to Week 24.
Inflammatory markers in blood and cerebrospinal fluid
Change in cerebrospinal fluid (CSF) and blood inflammatory markers, including but not limited to TNF-α, IL-1β, IL-2, IL-6, IL-8, IL-17, CHIT1, CHI3L1, CHI3L2, TGF-β, IL-10, and CRP
Measured: From up to 30 days before Week 0 to Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start15 Apr 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The first cohort (n = 3) will receive 0.4g/kg of IVIg, divided into two 0.2g/kg doses. After a preliminary safety and tolerability assessment of the first cohort, patients will be enrolled to the second cohort (n = 3). It will follow the same design but with 0.8g/kg divided into two 0.4g/kg doses.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193953
- Sponsor's protocol ID
- 6271
- Acronym
- ALSFUS003
- Status last verified
- Sep 2025
- First submitted
- 12 May 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Neuroinflammation With Enhanced Delivery of Intravenous Immunoglobulin to the Motor Cortex Using Next Generation Dome Helmet Focused Ultrasound in Amyotrophic Lateral Sclerosis: A Phase I, Open Label Trial
- ClinicalTrials.gov ID
- NCT07193953
- Acronym / sponsor ID
- ALSFUS003 / 6271
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Keywords
- ALS, Focused Ultrasound, Blood Brain Barrier Opening, Intravenous Immunoglobulin, Motor Neuron Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the safety and feasibility of IVIg administration in conjunction with primary motor cortex BBB opening using the Next Generation Dome Helmet (NGDH) FUS in adult participants with ALS.
Detailed description
This study is a prospective, single-arm, open-label, multiple-ascending dose (MAD), phase I trial to evaluate safety, feasibility, pharmacodynamics, and pharmacokinetics of enhanced delivery of IVIg 0.4 or 0.8g/kg to the primary motor cortex in 6 patients with ALS by using a single BBB opening procedure targeting the primary motor cortex in both brain hemispheres. Six participants will be enrolled in two sequential cohorts. The first cohort (n = 3) will receive 0.4g/kg of IVIg divided in two doses, while the second cohort (n = 3) will receive a 0.8g/kg of IVIg divided in two doses. In both cohorts, the second dose of IVIg will be accompanied by a single BBB opening procedure targeting the primary motor cortex in both brain hemispheres with focused ultrasound (FUS) using Next Generation Dome Helmet and intravenous microbubbles (DEFINITY®, Lantheus Medical Imaging Canada, Inc., Montreal, QC, Canada). This FUS procedure will occur during 2 weeks after the first dose administration. Follow-up visits will occur over the span of 24 weeks from the first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The first cohort (n = 3) will receive 0.4g/kg of IVIg, divided into two 0.2g/kg doses. After a preliminary safety and tolerability assessment of the first cohort, patients will be enrolled to the second cohort (n = 3). It will follow the same design but with 0.8g/kg divided into two 0.4g/kg doses.
| Arm | Type | Receives |
|---|---|---|
| Intravenous Immunoglobulin Administration using Focused Ultrasound | Experimental | Device: Next Generation Dome Helmet Focused Ultrasound, Drug: Intravenous immunoglobulin (IVIG), 10% solution for infusion, Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable SuspensionALS patients will be assigned to receive Intravenous Immunoglobulin (IVIg) and DEFINITY® microbubbles. The first three enrolled patients will participate in the first cohort, receiving 0.4g/kg divided in two doses. After a preliminary safety assessment of the first cohort, the next three successfully screened patients will be enrolled in the second cohort, receiving 0.8g/kg divided in two doses. The second IVIg dose in each cohort will be administered in combination with Next Generation Dome Helmet (NGDH) focused ultrasound (FUS) to transiently open the blood-brain barrier and enhance IVIg delivery to the primary motor cortex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with ALS as per the Gold Coast Criteria;
- Aged 18 years or older;
- Capable of providing informed consent and complying with study procedures;
- If taking Riluzole, on a stable dose for at least 4 weeks prior to Baseline;
- If taking Edaravone, on a stable dose of one completed cycle prior to Baseline;
Key exclusion criteria (44 listed)
- MRI findings:
- More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- Clips or other metallic implanted objects in the skull or the brain, except shunts
- Significant cardiac disease or unstable hemodynamic status including:
- Uncontrolled hypertension (systolic > 150 and diastolic BP > 100 on medication)
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 |
|---|---|---|
| Next Generation Dome Helmet Focused UltrasoundTwo doses of IVIg will be administered 2 weeks apart. The first dose at Week 0 will be a standalone administration. The second dose at Week 2 will be combined with Next Generation Dome Helmet (NGDH) Focused Ultrasound (FUS) blood brain barrier (BBB) opening. | Device | Intravenous Immunoglobulin Administration using Focused Ultrasound |
| Intravenous immunoglobulin (IVIG), 10% solution for infusionTwo doses of IVIg will be administered 2 weeks apart. The first dose at Week 0 will be a standalone administration. The second dose at Week 2 will be combined with Next Generation Dome Helmet (NGDH) Focused Ultrasound (FUS) blood brain barrier (BBB) opening. Cohort I will receive 0.2g/kg of IVIg at each dose. Cohort II will receive 0.4g/kg of IVIg at each dose. Privigen® IVIg comes in vials containing 10% active ingredient. It is supplied in 2.5 g (25 mL bottle), 5 g (50 mL bottle), 10 g (100 mL bottle), 20 g (200 mL bottle) or 40 g (400 mL bottle). The IVIg dose will be determined based on the patient's ideal body weight. | Drug | Intravenous Immunoglobulin Administration using Focused Ultrasound |
| Definity® Vial for (Perflutren Lipid Microsphere) Injectable SuspensionDEFINITY® Perflutren Injectable Microbubbles is an ultrasound contrast imaging agent that will be used for blood brain barrier opening during focused ultrasound. These microbubbles will be injected during the focused ultrasound procedure on the day of the second IVIg dose. | Drug | Intravenous Immunoglobulin Administration using Focused Ultrasound |
Primary outcome
Safety of IVIg in patients with ALS
Time frame: During and after IVIg administration at Week 0 and Week 2 Day 1 until Week 24.
This will be assessed up through the incidence of drug-related adverse events, serious adverse events, and discontinuations due to adverse events after Intravenous Immunoglobulin (IVIg) administration.
Safety of DEFINITY® microbubbles
Time frame: During and after DEFINITY® administration at Week 2 Day 1 until Week 24.
This will be assessed up through the incidence of drug-related adverse events, serious adverse events, and discontinuations due to adverse events after DEFINITY® infusion during focused ultrasound (FUS) blood brain barrier (BBB) opening.
Feasibility of FUS BBB opening in the motor cortex
Time frame: During and after Week 2 Day 1 FUS BBB opening until Week 24.
This will be measured as detectable gadolinium enhancement at the arm, leg and bulbar regions of the motor cortex bilaterally following FUS with posterior normalization.
Safety of FUS BBB opening in the motor cortex
Time frame: From up to 30 days before Week 0 to Week 24.
Incidence of BBB opening-related and FUS-related adverse events, serious adverse events, incidence of asymptomatic or symptomatic radiologic complication, such as evidence of bleeding or swelling after FUS, incidence of electrographic complication, such as epileptiform discharges on EEG, or accelerated ALS disease progression, defined as ≥ 6-point decline in the ALSFRS-R scores from Baseline to week 8.
2 secondary outcomes
Neurofilament light chain (NfL) levels in blood plasma and cerebrospinal fluid
Time frame: From up to 30 days before Week 0 to Week 24.
Inflammatory markers in blood and cerebrospinal fluid
Time frame: From up to 30 days before Week 0 to Week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Next Generation Dome Helmet Focused Ultrasound, Intravenous immunoglobulin (IVIG), 10% solution for infusion and Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension in people with Amyotrophic Lateral Sclerosis and ALS, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 44 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Safety of IVIg in patients with ALS (time frame: During and after IVIg administration at Week 0 and Week 2 Day 1 until Week 24.). The study lists 4 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 14 Jul 2026.