A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
| Registry | NCT03863080 |
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| Status | Completed |
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| Phase | Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 17 (Actual) |
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| Sponsor | Immunovant Sciences GmbH (Industry) |
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| Conditions | Myasthenia Gravis |
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| Interventions | RVT-1401, Placebo (Drug) |
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| Dates | start 2019-05-21, primary completion 2020-10-07, completion 2020-12-21, first posted 2019-03-05, last updated 2023-12-20 |
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| Locations | 20 sites in United States, Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Myasthenia Gravis All trials of RVT-1401 All trials of Placebo
-Summary
The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Regimen A | Experimental | Drug: RVT-1401 | RVT-1401 680 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| Regimen B | Experimental | Drug: RVT-1401 | RVT-1401 340 mg weekly for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
| Placebo | Placebo comparator | Drug: RVT-1401; Drug: Placebo | Placebo for 6 weeks + optional open-label extension (RVT-1401, 340 mg every 2 weeks for 6 weeks) |
- RVT-1401 (Drug): Subcutaneous administration of RVT-1401
- Placebo (Drug): Subcutaneous administration of Placebo
+Outcome measures
Primary outcomes
- Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Week 18]: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
- Open-Label Extension Period: Number of Participants Reporting AEs and SAEs [Up to Week 18]: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. SAEs were defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the other outcomes listed in the definition.
- Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs [Up to Week 7]: Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
- Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs [Up to Week 18]: Vital signs including SBP, DBP, pulse rate and temperature were measured after resting for at least 5 minutes in a semi-supine position.
- Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters [Up to Week 7]: Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
- Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters [Up to Week 18]: Clinical laboratory parameters included clinical chemistry, hematology and urinalysis.
- Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) [Up to Week 7]: Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
- Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG [Up to Week 18]: Twelve-lead ECG was performed after 5 minutes of rest in the supine position.
- Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG) [Baseline (Day 1) and Up to Week 7]: Serum samples were collected for the analysis of total immunoglobulin G. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
- Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4 [Baseline (Day 1) and Up to Week 7]: Serum samples were collected for the analysis of IgG 1, 2, 3 and 4 levels. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
- Double-Blind Treatment Period: Percent Change From Baseline in Anti-acetylcholine Receptor Immunoglobulin G (Anti-AChR-IgG) at Week 7 [Baseline (Day 1) and Week 7]: Serum samples were collected for the analysis of Anti-AChR-IgG. Percent change from Baseline was calculated as the mean value at the specified time frame (Week 7) minus the Baseline value, divided by the Baseline value x 100.
Secondary outcomes
- Double-Blind Treatment Period: Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 [Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8]: Blood samples were collected for the analysis of Pharmacokinetic parameter AUC (0-168h).
- Open-label Extension Period: AUC0-168h of RVT-1401 [Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14]: Pharmacokinetic parameters were not estimated because the sparse PK sampling schedule did not allow for accurate estimates of these parameters.
- Double-Blind Treatment Period: Maximum Concentration (Cmax) of RVT-1401 [Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8]: Blood samples were collected for the analysis of Pharmacokinetic parameter Cmax.
- Open-label Extension Period: Cmax of RVT-1401 [Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14]: Blood samples were collected for the analysis of Pharmacokinetic parameter Cmax.
- Double-Blind Treatment Period: Trough Concentrations (Ctrough) of RVT-1401 [Pre-dose]: Blood samples were planned to be collected at indicated time points to measure the concentration of RVT-1401 pre-dose (Ctrough) as an assessment of the pharmacokinetic RVT-1401.
- Open-label Extension Period: Ctrough of RVT-1401 [Pre-dose]: Blood samples were planned to be collected at indicated time points to measure the concentration of RVT-1401 pre-dose (Ctrough) as an assessment of the pharmacokinetic RVT-1401.
- Double-blind Treatment Period: Change From Baseline in the Quantitative Myasthenia Gravis Score (QMG) Score [Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36) and Week 7]: The QMG score is a physician-reported outcome measure was used to assess MG disease severity and pattern of deficits based on quantitative testing of affected muscle groups. The scale comprised of 13 test items that were graded on a scale of 0 (no myasthenic findings) to 3 (maximal myasthenic deficits). The total sum across all 13 items represents the QMG score. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
- Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the QMG Score From Baseline [Baseline (Day 1) to Week 7]: The response is defined as improvement from Baseline on the QMG score by => 3 points. The QMG score is a physician-reported outcome measure was used to assess MG disease severity and pattern of deficits based on quantitative testing of affected muscle groups. The scale comprised of 13 test items that were graded on a scale of 0 (no myasthenic findings) to 3 (maximal myasthenic deficits). The total sum across all 13 items represents the QMG score. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
- Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score [Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7]: The MG-ADL is an 8-item, participant-reported outcome measure that assessed Myasthenia Gravis symptoms and their effects on activities of daily living, with each response graded from 0 (normal) to 3 (most severe). The MG-ADL score was calculated by totaling the rating for each of the 8 items. Total MG-ADL scores range from 0 to 24 with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
- Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the MG-ADL Score [Baseline (Day 1) to Week 7]: The response was defined as improvement (decrease) from Baseline on the MG-ADL score by => 2 points. The MG-ADL is an 8-item, participant-reported outcome measure that assessed Myasthenia Gravis symptoms and their effects on activities of daily living, with each response graded from 0 (normal) to 3 (most severe). The MG-ADL score was calculated by totaling the rating for each of the 8 items. Total MG-ADL scores range from 0 to 24 with higher scores indicating more severe disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug.
- Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Composite Score (MGC) Score [Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7]: The MGC was developed by selecting the best performing items from 3 commonly used Myasthenia Gravis specific scales (QMG, Myasthenia Gravis manual muscle test, and MG-ADL) and is comprised of 10 functional domains: 3 ocular, 3 bulbar, 1 respiratory, 1 neck, and 2 limb items. The total score ranges from 0 (no myasthenic findings) to 50 (maximal myasthenic deficits). The scale measures symptoms and signs of MG in these domains incorporating both physician and participant-reported test items. Higher scores correlate with clinical worsening of the disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
- Double-Blind Treatment Period: Percentage of Participants With an Improvement on the MGC Score [Baseline (Day 1) to Week 7]: The response was defined as improvement (decrease) from Baseline on the MGC score by => 3 points. The MGC was developed by selecting the best performing items from 3 commonly used Myasthenia Gravis specific scales (QMG, Myasthenia Gravis manual muscle test, and MG-ADL) and is comprised of 10 functional domains: 3 ocular, 3 bulbar, 1 respiratory, 1 neck, and 2 limb items. The total score ranges from 0 (no myasthenic findings) to 50 (maximal myasthenic deficits). The scale measures symptoms and signs of MG in these domains incorporating both physician and participant-reported test items. Higher scores correlate with clinical worsening of the disease. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug.
- Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Quality of Life 15 Revised Score (MG-QOL 15r) Score [Baseline (Day 1) and at Week 4 and Week 7]: The MG-QOL15r is a participant-reported questionnaire designed to assess how a participant's Myasthenia Gravis affects different aspects related to their quality of life. The scale includes 15 items that are graded on a scale of 0 to2; the total across is the sum of all 15 items and represents the MG-QOL15r score. The range of the MG-QOL15r score is 0 - 30. Higher scores indicate worse outcomes. Baseline was defined as the last non-missing value prior to the date (time) of first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
- Double-Blind Treatment Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies [Up to Week 7]: The serum levels of anti-RVT-1401 antibodies were determined. All samples that were potentially positive were analyzed with the confirmation assay where presence of anti-RVT-1401 was confirmed; the therapeutic antibody was used to compete with the analytical responses of anti-drug antibody (ADA) to assess specificity of screened positive samples.
- Open-Label Extension Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies [Up to Week 18]: The serum levels of anti-RVT-1401 antibodies were determined. All samples that were potentially positive were analyzed with the confirmation assay where presence of anti-RVT-1401 was confirmed; the therapeutic antibody was used to compete with the analytical responses of ADA to assess specificity of screened positive samples.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
1. Male or female ≥ 18 years of age.
2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of a respirator for the duration of the study as judged by the Investigator.
3. QMG score ≥12 at Screening and Baseline.
Other, more specific inclusion criteria are defined in the protocol.
Exclusion Criteria:
1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing.
2. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
3. Thymectomy performed < 12 months prior to screening.
4. Total IgG level <6 g/L (at screening).
5. Absolute neutrophil count <1500 cells/mm3(at screening).
Other, more specific exclusion criteria are defined in the protocol
+Posted results
Participant flow
| Milestone | Double-blind Treatment Period: Placebo | Double-blind Treatment Period: RVT-1401 340 mg/Week | Double-blind Treatment Period: RVT-1401 680 mg/Week | Open-label Extension Period: RVT-1401 340 mg Biweekly |
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| Started | 6 | 5 | 6 | 0 |
| Completed | 6 | 5 | 5 | 0 |
| Not completed | 0 | 0 | 1 | 0 |
Outcome results
- Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 5; Double-blind Treatment Period: RVT-1401 340 mg/Week 4; Double-blind Treatment Period: RVT-1401 680 mg/Week 5
- Open-Label Extension Period: Number of Participants Reporting AEs and SAEs (Primary), Count of participants, Participants: Open-Label Extension Period: RVT-1401 340 mg Biweekly 10
- Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 0; Double-blind Treatment Period: RVT-1401 340 mg/Week 0; Double-blind Treatment Period: RVT-1401 680 mg/Week 0
- Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 0; Double-blind Treatment Period: RVT-1401 340 mg/Week 0; Double-blind Treatment Period: RVT-1401 680 mg/Week 0
- Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 0; Double-blind Treatment Period: RVT-1401 340 mg/Week 0; Double-blind Treatment Period: RVT-1401 680 mg/Week 0
- Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 0; Double-blind Treatment Period: RVT-1401 340 mg/Week 0; Double-blind Treatment Period: RVT-1401 680 mg/Week 0
- Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 0; Double-blind Treatment Period: RVT-1401 340 mg/Week 0; Double-blind Treatment Period: RVT-1401 680 mg/Week 0
- Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG (Primary), Count of participants, Participants: Double-blind Treatment Period: Placebo 0; Double-blind Treatment Period: RVT-1401 340 mg/Week 0; Double-blind Treatment Period: RVT-1401 680 mg/Week 0
- Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG) (Primary), Least squares mean, Percent change: Double-blind Treatment Period: Placebo -3.17 +/- 2.97; Double-blind Treatment Period: RVT-1401 340 mg/Week -59.49 +/- 3.15; Double-blind Treatment Period: RVT-1401 680 mg/Week -77.66 +/- 2.92 (p <0.0001)
- Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4 (Primary), Least squares mean, Percent change: Double-blind Treatment Period: Placebo -3.3 +/- 3.67; Double-blind Treatment Period: RVT-1401 340 mg/Week -65.9 +/- 4.02; Double-blind Treatment Period: RVT-1401 680 mg/Week -76.3 +/- 3.98 (p <0.001)
- Double-Blind Treatment Period: Percent Change From Baseline in Anti-acetylcholine Receptor Immunoglobulin G (Anti-AChR-IgG) at Week 7 (Primary), Least squares mean, Percent change: Double-blind Treatment Period: Placebo 15.92 +/- 12.41; Double-blind Treatment Period: RVT-1401 340 mg/Week -46.66 +/- 13.64; Double-blind Treatment Period: RVT-1401 680 mg/Week -85.28 +/- 12.27 (p 0.0009)
- Double-Blind Treatment Period: Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 (Secondary), Geometric mean, Hours*microgram per milliliter: Double-blind Treatment Period: RVT-1401 340 mg/Week NA +/- NA; Double-blind Treatment Period: RVT-1401 680 mg/Week NA +/- NA
- Open-label Extension Period: AUC0-168h of RVT-1401 (Secondary), Geometric mean, Hours*microgram per milliliter: Double-blind Treatment Period: RVT-1401 340 mg/Week NA +/- NA; Double-blind Treatment Period: RVT-1401 680 mg/Week NA +/- NA
- Double-Blind Treatment Period: Maximum Concentration (Cmax) of RVT-1401 (Secondary), Geometric mean, micrograms per milliliter: Double-blind Treatment Period: RVT-1401 340 mg/Week NA +/- NA; Double-blind Treatment Period: RVT-1401 680 mg/Week NA +/- NA
- Open-label Extension Period: Cmax of RVT-1401 (Secondary), Geometric mean, Micrograms per milliliter: Double-blind Treatment Period: RVT-1401 340 mg/Week NA +/- NA; Double-blind Treatment Period: RVT-1401 680 mg/Week NA +/- NA
- Double-Blind Treatment Period: Trough Concentrations (Ctrough) of RVT-1401 (Secondary), Mean, Milligrams per liter: Double-blind Treatment Period: RVT-1401 340 mg/Week NA +/- NA; Double-blind Treatment Period: RVT-1401 680 mg/Week NA +/- NA
- Open-label Extension Period: Ctrough of RVT-1401 (Secondary), Mean, Milligrams per liter: Double-blind Treatment Period: RVT-1401 340 mg/Week NA +/- NA; Double-blind Treatment Period: RVT-1401 680 mg/Week NA +/- NA
- Double-blind Treatment Period: Change From Baseline in the Quantitative Myasthenia Gravis Score (QMG) Score (Secondary), Mean, Scores on a scale: Double-blind Treatment Period: Placebo -3.3 +/- 2.16; Double-blind Treatment Period: RVT-1401 340 mg/Week -2.8 +/- 5.36; Double-blind Treatment Period: RVT-1401 680 mg/Week -1.7 +/- 3.14
- Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the QMG Score From Baseline (Secondary), Number, Percentage of participants: Double-blind Treatment Period: Placebo 20.0; Double-blind Treatment Period: RVT-1401 340 mg/Week 40.0; Double-blind Treatment Period: RVT-1401 680 mg/Week 60.0
- Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score (Secondary), Mean, Scores on a scale: Double-blind Treatment Period: Placebo -1.7 +/- 2.34; Double-blind Treatment Period: RVT-1401 340 mg/Week -3.2 +/- 6.61; Double-blind Treatment Period: RVT-1401 680 mg/Week -0.7 +/- 0.82
- 6 more outcome measures not shown.
Adverse events
Time frame: From Baseline and Up to Week 18
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Double-blind Treatment Period: Placebo | 0/6 (0.0%) | 0/6 (0.0%) | 5/6 (83.3%) |
| Double-blind Treatment Period: RVT-1401 340 mg/Week | 0/5 (0.0%) | 0/5 (0.0%) | 4/5 (80.0%) |
| Double-blind Treatment Period: RVT-1401 680 mg/Week | 0/6 (0.0%) | 1/6 (16.7%) | 5/6 (83.3%) |
| Open-label Extension Period: RVT-1401 340 mg Biweekly | 0/15 (0.0%) | 1/15 (6.7%) | 10/15 (66.7%) |
Serious adverse events by term
| Term | Organ system | Double-blind Treatment Period: Placebo | Double-blind Treatment Period: RVT-1401 340 mg/Week | Double-blind Treatment Period: RVT-1401 680 mg/Week | Open-label Extension Period: RVT-1401 340 mg Biweekly |
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| Herpes simplex | Infections and infestations | 0/6 | 0/5 | 1/6 | 0/15 |
| Myasthenia gravis | Nervous system disorders | 0/6 | 0/5 | 0/6 | 1/15 |
Other adverse events by term
| Term | Organ system | Double-blind Treatment Period: Placebo | Double-blind Treatment Period: RVT-1401 340 mg/Week | Double-blind Treatment Period: RVT-1401 680 mg/Week | Open-label Extension Period: RVT-1401 340 mg Biweekly |
|---|
| Gingival pain | Gastrointestinal disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Anal incontinence | Gastrointestinal disorders | 1/6 | 0/5 | 0/6 | 0/15 |
| Constipation | Gastrointestinal disorders | 1/6 | 0/5 | 0/6 | 0/15 |
| Diarrhoea | Gastrointestinal disorders | 1/6 | 0/5 | 0/6 | 0/15 |
| Nausea | Gastrointestinal disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Vomiting | Gastrointestinal disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Injection site erythema | General disorders | 1/6 | 2/5 | 1/6 | 2/15 |
| Injection site bruising | General disorders | 0/6 | 1/5 | 0/6 | 0/15 |
| Injection site haemorrhage | General disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Injection site swelling | General disorders | 1/6 | 1/5 | 0/6 | 1/15 |
| Vessel puncture site bruise | General disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Asthenia | General disorders | 1/6 | 0/5 | 0/6 | 0/15 |
| Injection site pain | General disorders | 1/6 | 0/5 | 0/6 | 0/15 |
| Facial pain | General disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Fatigue | General disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Upper respiratory tract infection | Infections and infestations | 0/6 | 1/5 | 0/6 | 0/15 |
| Urinary tract infection | Infections and infestations | 0/6 | 1/5 | 0/6 | 0/15 |
| Viral upper respiratory tract infection | Infections and infestations | 0/6 | 0/5 | 1/6 | 0/15 |
| Tonsillitis | Infections and infestations | 1/6 | 0/5 | 0/6 | 0/15 |
| Contusion | Injury, poisoning and procedural complications | 0/6 | 0/5 | 1/6 | 0/15 |
| Fall | Injury, poisoning and procedural complications | 1/6 | 0/5 | 0/6 | 0/15 |
| Red blood cell count increased | Investigations | 0/6 | 1/5 | 0/6 | 0/15 |
| White blood cells urine positive | Investigations | 0/6 | 1/5 | 0/6 | 0/15 |
| Total complement activity decreased | Investigations | 1/6 | 0/5 | 0/6 | 0/15 |
| Decreased appetite | Metabolism and nutrition disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Back pain | Musculoskeletal and connective tissue disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 2/6 | 1/5 | 0/6 | 1/15 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 1/6 | 0/5 | 0/6 | 0/15 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Dizziness | Nervous system disorders | 1/6 | 0/5 | 2/6 | 0/15 |
| Headache | Nervous system disorders | 3/6 | 1/5 | 0/6 | 2/15 |
| Myasthenia gravis | Nervous system disorders | 0/6 | 0/5 | 0/6 | 2/15 |
| Ataxia | Nervous system disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Rash | Skin and subcutaneous tissue disorders | 0/6 | 0/5 | 1/6 | 0/15 |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | 0/6 | 0/5 | 0/6 | 1/15 |
| Herpes simplex | Infections and infestations | 0/6 | 0/5 | 1/6 | 0/15 |
+Locations (20)
| Facility | City | Country | Status |
|---|
| IMC/Diagnostic and Medical Clinic | Mobile, Alabama | United States | |
| Phoenix Neurological Associates | Phoenix, Arizona | United States | |
| The Neurology Center of Southern California | Carlsbad, California | United States | |
| UC Irvine - MDA ALS and Neuromuscular Center | Orange, California | United States | |
| Care Access Research | Pasadena, California | United States | |
| CSNA | Colorado Springs, Colorado | United States | |
| Yale School of Medicine Department of Neurology | New Haven, Connecticut | United States | |
| Neurological Services of Orlando | Orlando, Florida | United States | |
| Rare Disease Research | Atlanta, Georgia | United States | |
| University of Minnesota - Department of Neurology | Minneapolis, Minnesota | United States | |
| Dent Institute | Amherst, New York | United States | |
| University of Buffalo | Buffalo, New York | United States | |
| Hospital for Special Surgery | New York, New York | United States | |
| Allegheny Neurological Associates | Pittsburgh, Pennsylvania | United States | |
| UTSW James W. Aston Ambulatory Care Center - Neurology Clinic | Dallas, Texas | United States | |
| University of Alberta Hospitals - Division of Pulmonary Medicine | Edmonton, Alberta | Canada | |
| London Health Sciences Centre | London, Ontario | Canada | |
| Ottawa Hospital Research Institute | Ottawa, Ontario | Canada | |
| University Health Network Toronto General Hospital | Toronto, Ontario | Canada | |
| Montreal Neurological Institute and Hospital | Montreal, Quebec | Canada | |
+Study documents