Lambert Eaton Myasthenic Syndrome(LEMS)
Conditions
Interventions
DYD-301 tablet (amifampridine phosphate) will be administered in the range of 15 mg to 80 mg daily in 3 to 4 divided doses.
If the investigator determines that the subject has no safety concerns, the
Sponsors
Toide Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects are eligible to be included in the study only if all of the following criteria apply: 1) Patients who participated in the DYD-301-11 (LMS-005) study and completed the study without discontinuation 2) Patient is >=17year old male or female with LEMS 3) Patients who have agreed to use properly contraception themselves or their female partners to avoid becoming pregnant, if they or their female partners have child bearing potential. 4) Patients (or legal representatives of minor patients) who have received sufficient explanation about the objective and content of the clinical study, expected efficacy, pharmacological action, risks, etc., and who have obtained understanding and obtained written consent from the patient
Exclusion criteria
Exclusion criteria: The subjects who meet any of the following criteria will be excluded in the study: 1) Patients is, in the opinion of the Investigator, continued administration of DYD-301 tablets is not appropriate from the viewpoint of safety and efficacy and suitable in any other way to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events/ Adverse drug reaction, Vital sign, Laboratory test, ECGs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in SGI score ,CGI-I score | — |
Contacts
Public ContactDP contact
DyDo Pharma,Inc.
Outcome results
None listed