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The CMT-HI has been designed to meet all FDA guidance criteria as an instrument to support drug labeling claims.
About
Summary The CMT-Health Index (CMT-HI) is a disease-specific, patient-reported, outcome measure designed to reliably and responsively measure therapeutic benefit in Charcot-Marie-Tooth disease (CMT) clinical trials. The CMT-HI may also be used to measure overall patient health in a clinical setting. It covers the 18 areas of greatest importance to the adult CMT population and has been designed to satisfy recommendations from the FDA for use in drug labeling claims. The CMT-HI is capable of both classifying patients with inherited neuropathies and measuring clinically-relevant change in disease state during therapeutic trials