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Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG

NCT03304054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-03-12

Study results available
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Summary

Efficacy and safety of amifampridine phosphate in improving the activities of daily living for patients with antibody positive MuSK myasthenia gravis.

Conditions

  • Myasthenia Gravis, Generalized

Interventions

DRUG

Amifampridine Phosphate

tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day

DRUG

Placebo Oral Tablet

tablets matching amifampridine phosphate, 3 to 4 times a day

Sponsors & Collaborators

Principal Investigators

  • Renato Mantegazza, MD · Carlo Besta Neurologic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2020-01-31
Completion
2020-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304054 on ClinicalTrials.gov