Trial Outcomes & Findings for Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome (NCT NCT02687165)
NCT ID: NCT02687165
Last Updated: 2020-06-01
Results Overview
average pain over past week on the scale from 0-10. Data were not collected.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-06-01
Participant Flow
4 patients were screened, but none was randomized
4 patients were screened, but no one was randomized
Participant milestones
| Measure |
Milnacipran Augmented by D-cycloserine
participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving D-cycloserine in addition to Milnacipran
Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine
|
Milnacipran Augmented by Placebo
participants will be receiving Milnacipran for 12 weeks. During weeks 6-12 participants will be receiving placebo in addition to Milnacipran
Milnacipran and D-cycloserine: Milnacipran augmented by D-cycloserine
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome
Baseline characteristics by cohort
| Measure |
All Participants
n=4 Participants
participants were not randomized. reporting all subjects together.
|
|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: patients didn't compete the study. Data were not collected.
average pain over past week on the scale from 0-10. Data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Milnacipran Augmented by D-cycloserine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Milnacipran Augmented by Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place