ClinicalTrials.gg
Sign In
CompletedNCT03613129InTiMEUpdated May 12, 2020Results posted

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

A Phase 1/2 interventional study of CT38 in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by LUCINDA BATEMAN, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by LUCINDA BATEMAN, MD · Phase 1/2, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.

Enrollment
49th of 58
17 · median 50
Started
2018
with 1 other
Phase 1/2
4 of 86
1 open now
Registered
40th of 86
by date

Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 49th largest by enrollment of the 58 interventional ones that give a count, is one of 2 that started in 2018, is one of 4 in phase 1/2, and was the 40th registered.

Fatigue Syndrome, Chronic

264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.

Browse Fatigue Syndrome, Chronic studies →

Open to participants now

21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 86 studies in Fatigue Syndrome, Chronic with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome

Keywords

  • myalgic encephalomyelitis
  • chronic fatigue syndrome
  • corticotropin releasing-factor receptor subtype 2 (CRF2)
  • Alternative CRF2 names: CRFR2, CRH2, CRHR2
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provision of signed and dated form
  • Ability to read, understand and speak English
  • Living at an altitude between 3,500 and 5,500 feet above sea level for the past 1 year
  • Willing to perform an exercise test
  • Diagnosed with ME/CFS and meet the following 3 case definitions: Fukuda Research Case Definition for CFS (1994), Revised Canadian Consensus Criteria for ME/CFS (2010) and the Institute of Medicine (IOM) Clinical Diagnostic Criteria for ME/CFS (2015)
  • Relatively stable state of illness for the individual patient over the past 3 months
  • Male or female, between the ages of 18 and 60 years old
  • Males or females of agree to remain abstinent or use (or have their partner use) 2 acceptable methods of , starting from the time of informed consent through 28 days after the last dose of study drug. Acceptable methods of birth control during the study are intrauterine device, diaphragm with spermicide, contraceptive sponge, condom or vasectomy. Oral contraceptive pills may not be used as the sole method of contraception because the effect of CT38 on the efficacy of oral contraceptive pills has not yet been established
  • Stated willingness to comply with all study procedures and remain available for the study duration
  • Have mobile (smart) phone and access to the internet

Exclusion criteria

Exclusion Criteria:

  • Alternate medical or psychiatric illness that could explain the ME/CFS symptoms
  • Unwilling or unable to perform an exercise test
  • Active or uncontrolled co-morbidities which in the opinion of the PI may interfere with the ability of the patient to participate in the study. Co-morbidities may include acute infection, Crohn's disease, diabetes mellitus (Type 1 or Type 2, evidenced by a history of (A1C) > 7 at any time), Guillain-Barre syndrome, lupus, multiple sclerosis, myasthenia gravis, rheumatoid arthritis, or other such diseases that may be exclusionary. Particularly conditions or medications that cause immunodeficiency or will be excluded. Examples of such conditions can be found in the tables "Causes of Secondary Immunodeficiency" and "Some Drugs that Cause Immunosuppression" in the "Merck Manual"
  • Pregnancy, or while breast feeding. Women should not be enrolled within 6 months of giving birth and within 3 months of cessation of breast feeding
  • A > 35
  • Cigarette smoker or former smoker who has smoked within 6 months of the start of the study
  • Living at an altitude that is more than 1,000 feet (lower or higher) from the study site (which is 4,500 feet above sea level)

  • History of:

    • Major depression with psychotic or melancholic features before the diagnosis of ME/CFS, or active depression (major depression with psychotic or melancholic features) as determined by self-report
    • Untreated endocrine diagnoses including hypothyroidism (Hashimoto's, etc.), Grave's disease, adrenal insufficiency, hypogonadism (testosterone deficiency), diabetes mellitus or insipidus
    • Acute infection within the past 30 days
    • Within the last 3 years, any significant head injury, e.g., concussion with loss of consciousness, brain surgery, an automobile accident with head/neck injury, other traumatic brain injury
    • A supra-ventricular tachycardia or ventricular tachycardia, e.g., atrial fibrillation or flutter, paroxysmal atrial fibrillation, junctional tachycardia, ventricular tachycardia
    • Severe baseline hypotension defined as rested sitting systolic BP \< 100 mmHg or rested sitting diastolic BP \< 60 mmHg
    • Renal impairment based upon the local lab normal estimated (eGFR) (drug is cleared by passive renal filtration)
    • Known or allergies to tromethamine or Tween 80 (both in the drug product)
    • Substance abuse in the past 12 months as determined by self-report
  • Improvement in overall ME/CFS symptoms as a result of any treatment intervention in the past 3 months
  • Current treatment with medications that interact with pathways involving: (i) 5-hydroxytryptamine (5HT) (e.g., selective 5HT re-uptake inhibitors or selective serotonin reuptake inhibitors (SSRIs), 5HT and norepinephrine re-uptake inhibitors or serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors, triptans); (ii) norepinephrine (e.g., adrenergic agonists or antagonists, norepinephrine re-uptake inhibitors, norepinephrine and dopamine re- uptake inhibitors); (iii) dopamine (e.g., norepinephrine and dopamine re-uptake inhibitors); and (iv) cortisol pathways (e.g., oral , fludrocortisone).

  • Prior treatment with

    • Short-term (\< 2 weeks) antiviral or antibiotic medication or flu shot within the past 4 weeks
    • Long-term (> 2 weeks) antiretrovirals within the past 12 months
    • RituximabTM within 6 months
    • Any new prescription drug or herbal remedy within 2 weeks prior to the onset of the trial
  • Current participation in another clinical treatment trial
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    D0.20

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

    Drug: CT38

  • Active comparator
    D0.03

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

    Drug: CT38

  • Active comparator
    D0.06

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

    Drug: CT38

  • Active comparator
    D0.01

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

    Drug: CT38

Interventions

  • DrugCT38

    Infusion

06

What researchers measure

Primary outcomes

  1. Total Daily Symptom Score (TDSS)

    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)

    Time frame: 28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)

Secondary outcomes

  1. SF-36, PCS

    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)

    Time frame: Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)

  2. SF-36, MCS

    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)

    Time frame: Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)

07

Results

Posted Apr 30, 2020
Limitations and caveats
InTiME was based on a novel theory of ME/CFS and an unprecedented drug mechanism. Predicted doses had to be adjusted, limiting statistical inferences, but providing preliminary support for the hypothesis and treatment approach.

Participant flow

Pre-treatment Assessment
Participant flow — Pre-treatment Assessment
MilestoneScreen FailuresD0.01D0.03D0.06D0.20
Started33722
Completed03722
Not completed30000
Withdrew: Protocol violation20000
Withdrew: Withdrawal by subject10000
Treatment
Participant flow — Treatment
MilestoneScreen FailuresD0.01D0.03D0.06D0.20
Started03722
Completed03722
Not completed00000
Post-treatment Assessment
Participant flow — Post-treatment Assessment
MilestoneScreen FailuresD0.01D0.03D0.06D0.20
Started03722
Completed03722
Not completed00000

Outcome measures

PrimaryTotal Daily Symptom Score (TDSS)

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)

Time frame:
28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)
Reported as:
Mean · units on a scale
Total Daily Symptom Score (TDSS)
units on a scaleIntent-to-treatD0.01D0.03D0.06D0.20
Pre-treatment TDSS29.5 ± 9.428.7 ± 12.229.2 ± 11.431.3 ± 1.330.1 ± 8.0
Post-treatment TDSS25.3 ± 9.625.5 ± 10.521.7 ± 10.329.5 ± 3.533.0 ± 9.6
Statistical analysis
  • Intent-to-treat · t-test, 2 sided · p = 0.011
  • D0.01 · t-test, 2 sided · p = 0.136
  • D0.03 · t-test, 2 sided · p = 0.009
  • D0.06 · t-test, 2 sided · p = 0.451
  • D0.20 · t-test, 2 sided · p = 0.240
SecondarySF-36, PCS

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)

Time frame:
Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)
Reported as:
Mean · units on a scale
SF-36, PCS
units on a scaleIntent-to-treatD0.01D0.03D0.06D0.20
Pre-treatment PCS27.9 ± 4.025.9 ± 6.924.6 ± 3.727.6 ± 1.430.6 ± 1.4
Post-treatment PCS31.5 ± 5.829.1 ± 6.030.7 ± 5.327.0 ± 1.426.8 ± 0.9
Statistical analysis
  • Intent-to-treat · t-test, 2 sided · p = 0.039
  • D0.01 · t-test, 2 sided · p = 0.191
  • D0.03 · t-test, 2 sided · p = 0.016
  • D0.06 · t-test, 2 sided · p = 0.053
  • D0.20 · t-test, 2 sided · p = 0.060
SecondarySF-36, MCS

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)

Time frame:
Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)
Reported as:
Mean · units on a scale
SF-36, MCS
units on a scaleIntent-to-treatD0.01D0.03D0.06D0.20
Pre-treatment MCS34.0 ± 3.636.3 ± 3.228.9 ± 3.932.1 ± 3.235.8 ± 2.6
Post-treatment MCS34.8 ± 6.338.5 ± 9.129.9 ± 6.434.9 ± 5.631.5 ± 2.1
Statistical analysis
  • Intent-to-treat · t-test, 2 sided · p = 0.587
  • D0.01 · t-test, 2 sided · p = 0.618
  • D0.03 · t-test, 2 sided · p = 0.634
  • D0.06 · t-test, 2 sided · p = 0.355
  • D0.20 · t-test, 2 sided · p = 0.417

Adverse events

Collected over At least 10 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intent-to-treat0/14 (0%)1/14 (7.1%)14/14 (100%)
D0.010/3 (0%)0/3 (0%)3/3 (100%)
D0.030/7 (0%)0/7 (0%)7/7 (100%)
D0.060/2 (0%)0/2 (0%)2/2 (100%)
D0.200/2 (0%)1/2 (50%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventIntent-to-treatD0.01D0.03D0.06D0.20
TachycardiaCardiac disorders1/140/30/70/21/2
HypotensionVascular disorders1/140/30/70/21/2
Most frequent other events
Showing 10 of 47
Most frequent other events
EventIntent-to-treatD0.01D0.03D0.06D0.20
TachycardiaCardiac disorders2/140/30/70/22/2
FatigueGeneral disorders5/140/33/70/22/2
HeadacheNervous system disorders11/143/35/72/21/2
Facial flushingVascular disorders6/141/33/70/22/2
FlushingVascular disorders13/143/36/72/22/2
DysequilibriumNervous system disorders2/142/30/70/20/2
Shortness of breathRespiratory, thoracic and mediastinal disorders3/142/31/70/20/2
Sleep disorder disturbancePsychiatric disorders6/141/34/70/21/2
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders4/140/34/70/20/2
PalpitationsCardiac disorders2/140/31/71/20/2

Baseline characteristics

Age, Continuous
Age, Continuous(years)D0.01D0.03D0.06D0.20Total
Mean46.0 ± 8.239.7 ± 7.253.6 ± 0.644.6 ± 21.443.7 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)D0.01D0.03D0.06D0.20Total
Female15208
Male22026
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)D0.01D0.03D0.06D0.20Total
White352212
Other02002
Age, at diagnosis
Age, at diagnosis(years)D0.01D0.03D0.06D0.20Total
Mean33.7 ± 12.232.4 ± 10.446.0 ± 9.932.5 ± 24.734.6 ± 12.3
Disease onset
Disease onset(Participants)D0.01D0.03D0.06D0.20Total
Gradual23128
Sudden14106
Disease triggers
Disease triggers(Participants)D0.01D0.03D0.06D0.20Total
Infection362213
Toxins12014
Over-exertion01102
Emotion03014
08

Study locations

1 site
  • Bateman Horne Center
    Salt Lake City, Utah 84102, United States
09

References and documents

Publications

  • Pereira G, Gillies H, Chanda S, Corbett M, Vernon SD, Milani T, Bateman L. Acute Corticotropin-Releasing Factor Receptor Type 2 Agonism Results in Sustained Symptom Improvement in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Front Syst Neurosci. 2021 Sep 1;15:698240. doi: 10.3389/fnsys.2021.698240. eCollection 2021. PubMed 34539356 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2018 to primary completion in Apr 2019, 9 months.

Results were first posted in Apr 2020, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2018
First posted
Aug 2, 2018
StartActual
Jul 23, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
Apr 30, 2019
Results first posted
Apr 30, 2020
Last update
May 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03613129
Lead sponsor
LUCINDA BATEMAN, MD
Responsible party
LUCINDA BATEMAN, MD (Founder & Medical Director, Bateman Horne Center) — Sponsor-investigator
First posted
Aug 2, 2018
Start date
Jul 23, 2018
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019
Results posted
Apr 30, 2020
Last update
May 12, 2020

Study contacts

Lucinda Bateman, MD
principal investigator · Bateman Horne Center
Suzanne D Vernon, PhD
study director · Bateman Horne Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fatigue Syndrome, Chronic →

Other studies from this sponsor

LUCINDA BATEMAN, MD

Start the discussion