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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613129
Recruitment Status : Completed
First Posted : August 2, 2018
Results First Posted : April 30, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
LUCINDA BATEMAN, MD, Bateman Horne Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Intervention Drug: CT38
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Screen Failures D0.01 D0.03 D0.06 D0.20
Hide Arm/Group Description Patient enrolled, but screened-out before receiving treatment Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 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 0.20 μg/kg/hour, for 3 hours on each of 2 days
Period Title: Pre-treatment Assessment
Started 3 3 7 2 2
Completed 0 3 7 2 2
Not Completed 3 0 0 0 0
Reason Not Completed
Protocol Violation             2             0             0             0             0
Withdrawal by Subject             1             0             0             0             0
Period Title: Treatment
Started 0 3 7 2 2
Completed 0 3 [1] 7 2 [2] 2
Not Completed 0 0 0 0 0
[1]
ID35 received only 1 infusion (due to symptom worsening)
[2]
ID34 did not receive 3rd infusion (for lack of venous access)
Period Title: Post-treatment Assessment
Started 0 3 7 2 2
Completed 0 3 7 2 2
Not Completed 0 0 0 0 0
Arm/Group Title D0.01 D0.03 D0.06 D0.20 Total
Hide Arm/Group Description Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 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 0.20 μg/kg/hour, for 3 hours on each of 2 days Total of all reporting groups
Overall Number of Baseline Participants 3 7 2 2 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 7 participants 2 participants 2 participants 14 participants
46.0  (8.2) 39.7  (7.2) 53.6  (0.6) 44.6  (21.4) 43.7  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 2 participants 2 participants 14 participants
Female
1
  33.3%
5
  71.4%
2
 100.0%
0
   0.0%
8
  57.1%
Male
2
  66.7%
2
  28.6%
0
   0.0%
2
 100.0%
6
  42.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 3 participants 7 participants 2 participants 2 participants 14 participants
White
3
 100.0%
5
  71.4%
2
 100.0%
2
 100.0%
12
  85.7%
Other
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
2
  14.3%
Age, at diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 7 participants 2 participants 2 participants 14 participants
33.7  (12.2) 32.4  (10.4) 46.0  (9.9) 32.5  (24.7) 34.6  (12.3)
Disease onset  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 3 participants 7 participants 2 participants 2 participants 14 participants
Gradual
2
  66.7%
3
  42.9%
1
  50.0%
2
 100.0%
8
  57.1%
Sudden
1
  33.3%
4
  57.1%
1
  50.0%
0
   0.0%
6
  42.9%
Disease triggers  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 3 participants 7 participants 2 participants 2 participants 14 participants
Infection
3
 100.0%
6
  85.7%
2
 100.0%
2
 100.0%
13
  92.9%
Toxins
1
  33.3%
2
  28.6%
0
   0.0%
1
  50.0%
4
  28.6%
Over-exertion
0
   0.0%
1
  14.3%
1
  50.0%
0
   0.0%
2
  14.3%
Emotion
0
   0.0%
3
  42.9%
0
   0.0%
1
  50.0%
4
  28.6%
1.Primary Outcome
Title Total Daily Symptom Score (TDSS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intent-to-treat D0.01 D0.03 D0.06 D0.20
Hide Arm/Group Description:
All patients receiving test drug
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 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 0.20 μg/kg/hour, for 3 hours on each of 2 days
Overall Number of Participants Analyzed 14 3 7 2 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment TDSS 29.5  (9.4) 28.7  (12.2) 29.2  (11.4) 31.3  (1.3) 30.1  (8.0)
Post-treatment TDSS 25.3  (9.6) 25.5  (10.5) 21.7  (10.3) 29.5  (3.5) 33.0  (9.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-treat
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D0.01
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS
Statistical Test of Hypothesis P-Value 0.136
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection D0.03
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection D0.06
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS
Statistical Test of Hypothesis P-Value 0.451
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection D0.20
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS
Statistical Test of Hypothesis P-Value 0.240
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title SF-36, PCS
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intent-to-treat D0.01 D0.03 D0.06 D0.20
Hide Arm/Group Description:
All patients receiving test drug
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 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 0.20 μg/kg/hour, for 3 hours on each of 2 days
Overall Number of Participants Analyzed 14 3 7 2 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment PCS 27.9  (4.0) 25.9  (6.9) 24.6  (3.7) 27.6  (1.4) 30.6  (1.4)
Post-treatment PCS 31.5  (5.8) 29.1  (6.0) 30.7  (5.3) 27.0  (1.4) 26.8  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-treat
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D0.01
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection D0.03
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection D0.06
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection D0.20
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title SF-36, MCS
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intent-to-treat D0.01 D0.03 D0.06 D0.20
Hide Arm/Group Description:
All patients receiving test drug
Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 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 0.20 μg/kg/hour, for 3 hours on each of 2 days
Overall Number of Participants Analyzed 14 3 7 2 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment MCS 34.0  (3.6) 36.3  (3.2) 28.9  (3.9) 32.1  (3.2) 35.8  (2.6)
Post-treatment MCS 34.8  (6.3) 38.5  (9.1) 29.9  (6.4) 34.9  (5.6) 31.5  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intent-to-treat
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.587
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection D0.01
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.618
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection D0.03
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.634
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection D0.06
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.355
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection D0.20
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)
Statistical Test of Hypothesis P-Value 0.417
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame At least 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intent-to-treat D0.01 D0.03 D0.06 D0.20
Hide Arm/Group Description All patients receiving test drug Subcutaneous infusion of CT38 at 0.01 μg/kg/hour, for 3.5 hours on each of 3 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 0.20 μg/kg/hour, for 3 hours on each of 2 days
All-Cause Mortality
Intent-to-treat D0.01 D0.03 D0.06 D0.20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/3 (0.00%)      0/7 (0.00%)      0/2 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Intent-to-treat D0.01 D0.03 D0.06 D0.20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/3 (0.00%)      0/7 (0.00%)      0/2 (0.00%)      1/2 (50.00%)    
Cardiac disorders           
Tachycardia † 1 [1]  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders           
Hypotension † 1 [2]  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
1
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
[1]
Tachycardia resulting from too high a first-in-patient dose (predicted from healthy animals/humans that could not account for CRF2 upregulation), and an inadvertent protocol deviation that continued dosing after the dose-stopping criteria were met
[2]
Hypotension resulting from too high a first-in-patient dose (predicted from healthy animals/humans that could not account for CRF2 upregulation), and an inadvertent protocol deviation that continued dosing after the dose-stopping criteria were met
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intent-to-treat D0.01 D0.03 D0.06 D0.20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/14 (100.00%)      3/3 (100.00%)      7/7 (100.00%)      2/2 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders           
Swollen lymph nodes † 1  1/14 (7.14%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Cardiac disorders           
Palpitations † 1  2/14 (14.29%)  5 0/3 (0.00%)  0 1/7 (14.29%)  3 1/2 (50.00%)  2 0/2 (0.00%)  0
Premature ventricular contraction † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Tachycardia † 1  2/14 (14.29%)  2 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 2/2 (100.00%)  2
Ear and labyrinth disorders           
Tinnitus † 1  1/14 (7.14%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Eye disorders           
Conjunctivitis † 1  1/14 (7.14%)  2 0/3 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0
Hyperemic eyes † 1  1/14 (7.14%)  2 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  2
Gastrointestinal disorders           
Constipation † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Diarrhea † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Inflammatory bowel disease † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Nausea † 1  3/14 (21.43%)  4 0/3 (0.00%)  0 3/7 (42.86%)  4 0/2 (0.00%)  0 0/2 (0.00%)  0
Sore throat † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
General disorders           
Asthenia † 1  1/14 (7.14%)  2 0/3 (0.00%)  0 1/7 (14.29%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0
Body aches † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Body temperature abnormalities † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Fatigue † 1  5/14 (35.71%)  10 0/3 (0.00%)  0 3/7 (42.86%)  5 0/2 (0.00%)  0 2/2 (100.00%)  5
Influenza like illness † 1  3/14 (21.43%)  3 1/3 (33.33%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1
Malaise † 1  1/14 (7.14%)  2 0/3 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0
Myalgia † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Pain & discomfort † 1  1/14 (7.14%)  2 0/3 (0.00%)  0 1/7 (14.29%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0
Pyrexia † 1  2/14 (14.29%)  2 0/3 (0.00%)  0 1/7 (14.29%)  1 1/2 (50.00%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders           
Anorexia † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Chills † 1  3/14 (21.43%)  6 1/3 (33.33%)  4 1/7 (14.29%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1
Muscle fatigue † 1  1/14 (7.14%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders           
Agitation † 1  2/14 (14.29%)  3 1/3 (33.33%)  1 0/7 (0.00%)  0 1/2 (50.00%)  2 0/2 (0.00%)  0
Forgetfulness † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Headache † 1  11/14 (78.57%)  18 3/3 (100.00%)  6 5/7 (71.43%)  8 2/2 (100.00%)  3 1/2 (50.00%)  1
Restlessness † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Tremor † 1  2/14 (14.29%)  2 0/3 (0.00%)  0 1/7 (14.29%)  1 1/2 (50.00%)  1 0/2 (0.00%)  0
Wired † 1  1/14 (7.14%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Dysequilibrium † 1  2/14 (14.29%)  2 2/3 (66.67%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Paresthesia † 1  1/14 (7.14%)  1 1/3 (33.33%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Dizziness † 1  4/14 (28.57%)  4 1/3 (33.33%)  1 2/7 (28.57%)  2 0/2 (0.00%)  0 1/2 (50.00%)  1
Psychiatric disorders           
Anxiety State † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Cognitive disturbance † 1  1/14 (7.14%)  2 1/3 (33.33%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Emotional lability † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Sleep disorder disturbance † 1  6/14 (42.86%)  7 1/3 (33.33%)  1 4/7 (57.14%)  5 0/2 (0.00%)  0 1/2 (50.00%)  1
Suicidal ideation † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders           
Cough † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Shortness of breath † 1  3/14 (21.43%)  3 2/3 (66.67%)  2 1/7 (14.29%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Sinus infection † 1  1/14 (7.14%)  2 0/3 (0.00%)  0 1/7 (14.29%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0
Upper respiratory tract infection † 1  4/14 (28.57%)  4 0/3 (0.00%)  0 4/7 (57.14%)  4 0/2 (0.00%)  0 0/2 (0.00%)  0
Vascular disorders           
Facial flushing † 1  6/14 (42.86%)  10 1/3 (33.33%)  1 3/7 (42.86%)  7 0/2 (0.00%)  0 2/2 (100.00%)  2
Flushing † 1  13/14 (92.86%)  27 3/3 (100.00%)  6 6/7 (85.71%)  14 2/2 (100.00%)  5 2/2 (100.00%)  2
Hot flushes † 1  3/14 (21.43%)  3 1/3 (33.33%)  1 2/7 (28.57%)  2 0/2 (0.00%)  0 0/2 (0.00%)  0
Hypotension † 1  2/14 (14.29%)  2 0/3 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1
Pallor † 1  1/14 (7.14%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lucinda Bateman, MD
Organization: Bateman Horne Center
Phone: (801) 359-7400
EMail: LBateman@batemanhornecenter.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: LUCINDA BATEMAN, MD, Bateman Horne Center
ClinicalTrials.gov Identifier: NCT03613129    
Other Study ID Numbers: ME-101p
First Submitted: July 13, 2018
First Posted: August 2, 2018
Results First Submitted: April 19, 2020
Results First Posted: April 30, 2020
Last Update Posted: May 12, 2020