Trial Outcomes & Findings for Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease (NCT NCT03891667)
NCT ID: NCT03891667
Last Updated: 2025-01-09
Results Overview
This is a psychometrically validated self-report measure of fatigue. This measure consists of 11 items inquiring about the severity of fatigue in different situations during the past week. Scores for each item range from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement. Higher scores indicate higher levels of fatigue. A responder on the FSS is an individual whose FSS total score has decreased by 0.7 its when compared baseline to week 10 (or last observation carried forward); 0.7 refers to the minimally clinical significant difference (MCID) in change over time. We report the number of participants who reached a meaningful reduction in fatigue (equal or more than MCID).
COMPLETED
PHASE1/PHASE2
11 participants
Change will be assessed over a 10 week interval
2025-01-09
Participant Flow
There were no pre-assignment procedures in the protocol.
Participant milestones
| Measure |
8 Week Disulfiram
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
Start of the Medication
|
5
|
4
|
|
Overall Study
Completed All 8 Weeks of Drug Treatment
|
1
|
2
|
|
Overall Study
Completed All 10 Weeks of Assessments
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
8 Week Disulfiram
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
COVID related pause
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease
Baseline characteristics by cohort
| Measure |
8 Week Disulfiram
n=6 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.83 years
STANDARD_DEVIATION 13.78 • n=99 Participants
|
37.8 years
STANDARD_DEVIATION 14.16 • n=107 Participants
|
40 years
STANDARD_DEVIATION 13.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change will be assessed over a 10 week intervalPopulation: We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug.
This is a psychometrically validated self-report measure of fatigue. This measure consists of 11 items inquiring about the severity of fatigue in different situations during the past week. Scores for each item range from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement. Higher scores indicate higher levels of fatigue. A responder on the FSS is an individual whose FSS total score has decreased by 0.7 its when compared baseline to week 10 (or last observation carried forward); 0.7 refers to the minimally clinical significant difference (MCID) in change over time. We report the number of participants who reached a meaningful reduction in fatigue (equal or more than MCID).
Outcome measures
| Measure |
8 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=4 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
Fatigue Severity Scale (FSS)
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Change will be assessed over a 10 week intervalPopulation: We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug.
The Q-LES-Q - SF is a self-reported questionnaire, with 16 items evaluating overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items, about medications and overall life satisfaction, are considered independently. Meaningful improvement on the Q-LES-Q to is a change score between baseline and week 10 (or last observation carried forward) of at least 6.8 points; 6.8 refers to the minimally clinical significant difference (MCID) where a score equal to or greater than 6.8 points represents an improved quality of file. We report # with meaningful improvement.
Outcome measures
| Measure |
8 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=4 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Change will be assessed over a 10 week intervalPopulation: We conduct an intent to treat analysis which covers all enrolled patients who received study drug.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The 8 scales are-vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning mental health. Each scale is directly transformed into a 0-100 scale, the lower the score the more disability and the higher the score the less disability. We calculate the Physical Component Summary (PCS) (representing physical functioning) which represent the items in the SF-36 representing physical functioning (Ware, 2000); as in the sub scales, lower scores indicate greater disability.The norm-based estimate has a mean of 50 and a standard deviation of 10. We report the magnitude of the score change from baseline to week 10 (or the last observation carried forward (LOCF); negative change scores indicate improvement.
Outcome measures
| Measure |
8 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=4 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
The Short Form (36) Health Survey (SF-36) Physical Component Summary (PCS)
|
-5.183 Score on scale (baseline minus LOCF)
Standard Deviation 4.126
|
-6.466 Score on scale (baseline minus LOCF)
Standard Deviation 5.374
|
SECONDARY outcome
Timeframe: Change will be assessed over a 10 week intervalPopulation: We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug.
This is a psychometrically validated 30 item self-report measure of symptom burden. The measure asks participants to rate how bothered they have been with a particular symptom over a 2-week time frame. Responses are made on 5-point Likert scale ranging from "not at all" to "very much" (scored 0-4); and the total score ranges from 0-120. Higher scores indicate more symptom severity. We report the magnitude of the score change (week 10 or last observation carried forward (LOCF)) minus the baseline score; a positive change score indicates improvement.
Outcome measures
| Measure |
8 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=4 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom Burden
|
25.6 change in score (baseline minus LOCF)
Standard Deviation 12.402
|
6.25 change in score (baseline minus LOCF)
Standard Deviation 20.790
|
SECONDARY outcome
Timeframe: Change will be assessed over a 10 week intervalPopulation: We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug.
The PROMIS-29 is a psychometrically validated 29 item self-report measure covering 7 domains. The questions are ranked on a 5-point Likert Scale. The composite score on 5 symptoms of the 7 domains is known as the SPADE summary score (sleep disturbance, pain, anxiety, depression, and low energy/fatigue); this represents the most common chronic symptoms in the general population. Each domain has 5 response options (e.g., 1=not at all to 5=very much), with scale scores ranging from 4 to 20 and higher scores indicating worse symptom severity. Using the scores from these 5 domains, we calculated the average score (SPADE score); the SPADE score ranges from 1 to 5 with higher scores indicating more symptom severity. We report the magnitude of the change in SPADE scores from baseline to week 10 (or the last observation carried forward (LOCF)); a positive change score indicates improvement.
Outcome measures
| Measure |
8 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=4 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE)
|
6.86 Score on scale (baseline minus LOCF)
Standard Deviation 3.71
|
5.95 Score on scale (baseline minus LOCF)
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: Change will be assessed over a 10 week intervalPopulation: We conduct an intent to treat analysis which covers all enrolled and randomized patients who received study drug.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The 8 scales are-vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning mental health. Each scale is directly transformed into a 0-100 scale, the lower the score the more disability and the higher the score the less disability. We calculate the Mental Component Summary (MCS) (representing physical functioning) which represent the items in the SF-36 representing physical functioning (Ware, 2000); as in the sub scales, lower scores indicate greater disability.. The norm-based estimate mean is 50 with a standard deviation of 10. We report the magnitude of the change in scores from baseline to week 10 (or the last observation carried forward (LOCF)); a negative change score indicates improvement.
Outcome measures
| Measure |
8 Week Disulfiram
n=5 Participants
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
4 Week Disulfiram
n=4 Participants
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
|
|---|---|---|
|
The Short Form (36) Health Survey (SF-36) Mental Component Summary (MCS)
|
-3.76 Score on scale (baseline minus LOCF)
Standard Deviation 15.437
|
-4.814 Score on scale (baseline minus LOCF)
Standard Deviation 5.486
|
Adverse Events
8 Week Disulfiram
4 Week Disulfiram
Serious adverse events
| Measure |
8 Week Disulfiram
n=5 participants at risk
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 8 weeks .
|
4 Week Disulfiram
n=4 participants at risk
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks .
|
|---|---|---|
|
Immune system disorders
ER visit
|
0.00%
0/5 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
25.0%
1/4 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
Hepatobiliary disorders
Short-term hospitalization
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
Other adverse events
| Measure |
8 Week Disulfiram
n=5 participants at risk
Patients in this group receive disulfiram for 8 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg for week 3, and 500 mg daily for week 4 to week 8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 8 weeks .
|
4 Week Disulfiram
n=4 participants at risk
Patients in this group receive disulfiram for 4 weeks followed by placebo capsules for 4 weeks. The dosing schedule is fixed-flexible, starting at 250 mg every other day at week 1, 250 mg daily for week 2, 250 mg alternating with 500 mg during week 3, and 500 mg daily during week 4. Placebo capsules are given during weeks 5-8. Dose increases are based on clinical judgment guided by patient tolerance, response, body weight, and side effects.
Disulfiram: Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks .
|
|---|---|---|
|
Hepatobiliary disorders
Mild-moderately elevated liver function tests
|
60.0%
3/5 • Number of events 3 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
Renal and urinary disorders
Mildly elevated serum creatinine
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
General disorders
Moderate headache
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
General disorders
Moderate to severe sore throat/throat hoarseness
|
40.0%
2/5 • Number of events 2 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
General disorders
Moderate to severe hypersomnia/sleepiness
|
40.0%
2/5 • Number of events 2 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
Ear and labyrinth disorders
Moderate tinnitus
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
Nervous system disorders
Moderate shooting pain
|
0.00%
0/5 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
25.0%
1/4 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
Musculoskeletal and connective tissue disorders
Moderate neuromotor weakness
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
Eye disorders
Moderate photosensitivity
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
General disorders
Moderate dizziness
|
20.0%
1/5 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
0.00%
0/4 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
|
General disorders
Moderate temperature fluctuations
|
0.00%
0/5 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
25.0%
1/4 • Number of events 1 • up to 14 weeks
11 patients signed consent and were randomized. 1 of these did not take any medication due to the onset of the COVID pandemic. 1 had data removed due to a later identified ineligibility.
|
Additional Information
Dr. Brian A. Fallon
Lyme Research Center New York State Psychiatric Institute, New York, New York, United States, 10032
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place