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).

patients with postural orthostatic tachycardia syndrome diagnosis.

Patients with Postural orthostatic tachycardia syndrome who has peripheral neuropathy

Whole blood will be retain for DNA extraction.

Postural Tachycardia Syndrome

Oral glucose tolerance test

Vanderbilt University Medical Center

Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome

POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AND GASTROINTESTINAL SYMPTOMS: Contribution of Gastrointestinal Peptides

The plasma levels of GI peptides (GLP-1, GLP-2, PPY, glucagon, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.

Gastric emptying time will be measured by acetaminophen absorption test after ingestion of 75 grams glucose.

The gastrointestinal symptoms will be evaluated by questionnaire after ingestion of 75 grams glucose.

Symptoms related to postural orthostatic tachycardia symptoms will be evaluated by specific questionnaire after ingestion of 75 grams glucose.

orthostatic intolerance/diarreya

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

Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome

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