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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 39 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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 weeks
Treatment ~ Varies
Follow Up ~over 39 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 39 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)

Side effects data

From 2020 Phase 3 trial • 93 Patients • NCT03304054
43%
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%
Feeling cold
3%
Urinary tract infection
3%
Sensory disturbance
3%
Vomiting
3%
Asthenia
3%
Nasopharyngitis
3%
Abdominal pain
3%
Back pain
3%
Tinnitus
3%
Dyspnoea
3%
Oropharyngeal pain
2%
Rash maculo-papular
2%
Palpitations
2%
Anxiety
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: amifampridine phosphateExperimental Treatment1 Intervention
tablets equivalent to 10mg amifampridine, 3 to 4 times per day. Initially, the daily amifampridine doses were to be the doses that were determined at the end of the Run-in Period from the MSK-002 study. The usual range was from 30 to 80 mg total daily dose, given in three (3) or four (4) doses, with no single dose \> 20 mg
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
14 Previous Clinical Trials
1,056 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
~9 spots leftby Oct 2025
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