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Potassium Channel Blocker
Amifampridine Phosphate for Myasthenia Gravis
Phase 3
Waitlist Available
Led By Renato Mantegazza, MD
Research Sponsored by Catalyst 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 over 21 months
Awards & highlights
Study Summary
This trial will evaluate the long-term safety of a drug that may help people with MuSK-MG, a disease that causes muscle weakness.
Eligible Conditions
- Myasthenia Gravis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Side effects data
From 2020 Phase 3 trial • 93 Patients • NCT0330405443%
Paraesthesia oral
40%
Paraesthesia
16%
Nausea
14%
Diarrhoea
13%
Headache
12%
Fatigue
10%
Hypoaesthesia oral
9%
Dizziness
8%
Abdominal pain upper
8%
Dyspepsia
6%
Muscle spasms
6%
Peripheral coldness
6%
Abdominal discomfort
5%
Pain in extremity
5%
Hypoaesthesia
3%
Urinary tract infection
3%
Sensory disturbance
3%
Feeling cold
3%
Vomiting
3%
Asthenia
3%
Nasopharyngitis
3%
Abdominal pain
3%
Back pain
3%
Tinnitus
3%
Dyspnoea
3%
Oropharyngeal pain
2%
Palpitations
2%
Anxiety
2%
Rash maculo-papular
2%
Feeling hot
2%
Ear infection
2%
Sinusitis
2%
Diplopia
2%
Fall
2%
Muscular weakness
2%
Speech disorder
2%
Insomnia
2%
Cough
1%
Myasthenia gravis
1%
Myasthenia gravis crisis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amifampridine Phosphate
Placebo
Overall
Trial Design
1Treatment groups
Experimental Treatment
Group I: amifampridine phosphateExperimental Treatment1 Intervention
tablets equivalent to 10mg amifampridine, 3 to 4 times per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amifampridine Phosphate
2019
Completed Phase 3
~170
Find a Location
Who is running the clinical trial?
Catalyst Pharmaceuticals, Inc.Lead Sponsor
13 Previous Clinical Trials
806 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
93 Patients Enrolled for Myasthenia Gravis
Renato Mantegazza, MDPrincipal InvestigatorCarlo Besta Neurological Institute
2 Previous Clinical Trials
148 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
93 Patients Enrolled for Myasthenia Gravis
Frequently Asked Questions
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