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Monoclonal Antibodies
1 for Myasthenia Gravis
Phase 2
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Summary
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.
Eligible Conditions
- Myasthenia Gravis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.
Secondary outcome measures
Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.
Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)
Change From Baseline in the MGFA Post-Intervention Status (PIS)
+4 moreSide effects data
From 2021 Phase 3 trial • 119 Patients • NCT0200314422%
Upper respiratory tract infection
19%
Headache
19%
Arthralgia
17%
Nasopharyngitis
17%
Urinary tract infection
15%
Pyrexia
14%
Back pain
13%
Influenza
9%
Fatigue
9%
Pain in extremity
8%
Anaemia
8%
Diarrhoea
8%
Constipation
6%
Iron deficiency anaemia
6%
Muscle spasms
6%
Dizziness
6%
Oropharyngeal pain
6%
Hypoaesthesia
6%
Cough
6%
Cystitis
6%
Musculoskeletal pain
5%
Periodontitis
5%
Oedema peripheral
5%
Dental caries
5%
Contusion
5%
Rash
5%
Muscular weakness
5%
Oral herpes
5%
Bronchitis
5%
Rhinorrhoea
4%
Neuromyelitis optica spectrum disorder
4%
Insomnia
4%
Paraesthesia
4%
Nausea
4%
Thermal burn
3%
Pyelonephritis acute
3%
Optic neuritis
3%
Intervertebral disc protrusion
3%
Dyspepsia
3%
Peripheral swelling
3%
Asthma
3%
Urosepsis
3%
Herpes zoster
1%
Ventricular fibrillation
1%
Device related infection
1%
Abscess limb
1%
Glaucoma
1%
Infective tenosynovitis
1%
Staphylococcal bacteraemia
1%
Cholecystitis acute
1%
Respiratory tract infection
1%
Muscle spasticity
1%
COVID-19 pneumonia
1%
COVID-19
1%
Femoral neck fracture
1%
Escherichia pyelonephritis
1%
Pneumonia bacterial
1%
Pyelonephritis
1%
Streptococcal infection
1%
Wrist fracture
1%
Hypophosphataemia
1%
Clavicle fracture
1%
Spondylolisthesis
1%
Pulmonary embolism
1%
Neuromuscular blockade
1%
Neuromyelitis optica pseudo relapse
1%
Anembryonic gestation
1%
Urinary retention
1%
Endometriosis
1%
Bronchiectasis
1%
Venous thrombosis limb
1%
Pharyngitis
1%
Toothache
1%
Urinary incontinence
1%
Pneumonia
1%
Gastroenteritis
1%
Psoas abscess
1%
Head injury
1%
Spinal compression fracture
1%
Sinusitis
1%
Osteonecrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eculizumab/Eculizumab
Eculizumab (Combined Total)
Placebo/Eculizumab
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
eculizumab
Group II: 2Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eculizumab
FDA approved
Find a Location
Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.Lead Sponsor
257 Previous Clinical Trials
41,051 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
1,339 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,342 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,264 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
39,256 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,264 Patients Enrolled for Myasthenia Gravis
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