. 2021 Jan 22;22:84. doi: 10.1186/s13063-020-05009-3

Table 2.

Inclusion criteria for patient participation in the Extension Study

Inclusion Criteria
1. Completed Visit 6 of the IB1001-201 / IB1001-202 / IB1001-203 Parent Study 2. The Principal Investigator determines further treatment with IB1001 to be in patient’s best interest 3. Written informed consent signed by the patient and/or their legal representative/parent/ impartial witness for participation in the Extension Phase 4. Patients are willing to continue to remain without the following prohibited medication from Visit 6 throughout the duration the Extension Phase: a) Aminopyridines (including sustained-release form); b) N-Acetyl-DL-Leucine (e.g. Tanganil®); c) N-Acetyl-L-Leucine (prohibited if not provided as investigational medicinal product [IMP]); d) Riluzole; e) Gabapentin; f) Varenicline; g) Chlorzoxazone; h) Sulfasalazine; i) Rosuvastatin.

Inclusion Criteria

1. Completed Visit 6 of the IB1001-201 / IB1001-202 / IB1001-203 Parent Study

2. The Principal Investigator determines further treatment with IB1001 to be in patient’s best interest

3. Written informed consent signed by the patient and/or their legal representative/parent/ impartial witness for participation in the Extension Phase

4. Patients are willing to continue to remain without the following prohibited medication from Visit 6 throughout the duration the Extension Phase:

a) Aminopyridines (including sustained-release form);

b) N-Acetyl-DL-Leucine (e.g. Tanganil®);

c) N-Acetyl-L-Leucine (prohibited if not provided as investigational medicinal product [IMP]);

d) Riluzole;

e) Gabapentin;

f) Varenicline;

g) Chlorzoxazone;

h) Sulfasalazine;

i) Rosuvastatin.