Subcutaneous infusion of CT38 at 0.20 μg/kg/hour, for 3 hours on each of 2 days

Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days

Subcutaneous infusion of CT38 at 0.06 μg/kg/hour, for 3.5 hours on each of 3 days

Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 days

D0.01

D0.03

D0.06

D0.20

Total

Sex: Female, Male

Race/Ethnicity, Customized

Age, at diagnosis

Disease onset

Disease triggers

Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)

Intent-to-treat

Total Daily Symptom Score (TDSS)

Pre-/post-treatment difference in the physical component score (PCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)

SF-36, PCS

Pre-/post-treatment difference in the mental component score (MCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)

SF-36, MCS

Patient enrolled, but screened-out before receiving treatment

Screen Failures

Pre-treatment Assessment

Treatment

Post-treatment Assessment

Lucinda Bateman, MD

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

CT38

Bateman Horne Center

Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

Pilot Phase 1/2, Open-Label, Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

LUCINDA BATEMAN, MD

Founder & Medical Director

The study is comprised of a recruitment and screening period, enrollment (Visit 1), a 4-week (at least) pre-treatment assessment period, a 1-week interventional treatment period with drug infused at Visits 3, 4 and 4b, a 4-week (at least) post-treatment assessment period, and a close-out (Visit 6).

orthostatic intolerance/qızdırma

Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

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