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Table 2 Nerve conduction study variables. Primary endpoint – Primary analysis

From: High-dose pharmaceutical-grade biotin in patients with demyelinating neuropathies: a phase 2b open label, uncontrolled, pilot study

Group

n

10% Improvement for at least 3 motor nerves

Motor Nerve Conduction Velocity (m/s)

Distal Motor Latency (ms)

F Wave Latency (ms)

Duration of the Compound Muscle Action Potential (ms)

Meeting Primary endpoint (change of 2 out of 4 variables)

All

15

No

13 (87%)

11 (73%)

15 (100%)

11 (73%)

14 (93%)

Yes

2 (13%)

4 (27%)

0

4 (27%)

1 (7%)

CIDP

5

No

4 (80%)

4 (80%)

5 (100%)

4 (80%)

5 (100%)

Yes

1 (20%)

1 (20%)

0

1 (20%)

0

anti-MAG

5

No

5 (100%)

3 (60%)

5 (100%)

5 (100%)

5 (100%)

Yes

0

2 (40%)

0

0

0

CMT1

5

No

4 (80%)

4 (80%)

5 (100%)

2 (40%)

4 (80%)

Yes

1 (20%)

1 (20%)

0

3 (60%)

1 (20%)

  1. Number of patients (%) with at least 10% improvement at W48 for at least 3 of the 8 explored motor nerves for each variable of motor nerve conduction considered in the primary endpoint, which was met (last column) if such a 10% improvement was achieved in at least 2 of the 4 motor nerve conduction study variables. Missing data at W48 (for patients #04 and #09) were imputed with the LOCF method