Chronic Fatigue Syndrome Clinical Trial
Official title:
Pilot Phase 1/2, Open-Label, Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
This study seeks to investigate the safety, tolerability and efficacy of CT38, an experimental peptide administered by subcutaneous infusion, in the treatment of ME/CFS patients.
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is a complex disorder that may
be triggered by infection or other stressors (e.g., emotional or physical trauma, immune
activation, chemical exposures). Its hallmark is a reduced capacity for physical and mental
activity manifest as profound fatigue along with a cascade of debilitating symptoms
(including pain, cognitive dysfunction, orthostatic intolerance, sensitivities, and
irregularities of the autonomic, immune and metabolic systems) that worsen with activity
(referred to as post-exertional malaise or PEM), are not improved by sleep, and can persist
for years. Patients are often unable to handle the activities of daily living and experience
a loss of career and a very poor quality of life. There are no established diagnostic tests
or approved therapeutics for ME/CFS.
The cause of ME/CFS is not known. It has been postulated that ME/CFS could arise from the
up-regulation of a specific receptor (CRF2) in those parts of the brain that govern the
sensitivity of the stress response. This configuration would invoke a major response to a
minor stimulus, ultimately leading to neuroendocrine, autonomic, immune and metabolic
abnormalities that are commonly observed. There is no animal model of ME/CFS, but
overstimulating CRF2 in healthy rats, induces signs and symptoms consistent with the disease
in humans; while down-regulating it, via CT38 (an experimental peptide), eliminates the
ability to stimulate these signs and symptoms. Hypothesis: Utilize CT38 to down-regulate CRF2
to restore a normal stress response, and potentially eliminate disease signs and symptoms.
The study will enroll 18 patients, who meet the Fukuda and Canadian criteria for ME/CFS, and
treat them with various doses of CT38.
The primary endpoint will be the change in the average total daily symptom score (TDSS), over
28-day periods immediately prior to the first treatment (pre-treatment) and immediately prior
to exit from the trial (post-treatment). The TDSS is the sum of 13 individual symptom scores,
each recorded daily by the patient on a 6-point scale (0=none, 1=very mild, 2=mild,
3=moderate, 4=severe, 5=very severe). The individual symptoms included fatigue, muscle/joint
pain, sleep issues (e.g., un-refreshing sleep, difficulty falling or staying asleep,
excessive sleepiness), cognitive issues (e.g., slow information processing, memory
difficulties, inability to concentrate/focus, attention deficit), orthostatic intolerance
(e.g., dizziness, spatial disorientation, light-headedness, feeling faint), body temperature
perceptions, flu-like symptoms (e.g., sore throat, tender lymph nodes, swollen glands, fever,
chills, sinus/nasal problems), headaches or sensory sensitivities (to light, sound, smell,
touch, taste), shortness of breath, gastrointestinal problems (e.g., nausea,
stomach/abdominal pain, diarrhea), urogenital problems (e.g., frequent urination), anxiety
and depression.
The secondary outcomes will assess general health status (determined by Short-Form 36, or
SF-36), as well as safety assessments.
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