What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Pyridostigmine, Low-Dose Naltrexone, or Placebo. The registry lists allocation as randomized. The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI).
They plan to enroll about 160 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
LIFT: Life Improvement Trial
Interventions: Pyridostigmine, Low-Dose Naltrexone, Placebo
Primary outcome (registry wording): Functional Capacity