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Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome (PTLS)

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: NCT02687165
Recruitment Status : Terminated (Slow recruitment due to strict inclusion/exclusion criteria)
First Posted : February 22, 2016
Results First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Alla Landa, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Post Treatment Lyme Syndrome (PTLS)
Chronic Pain
Intervention Drug: Milnacipran and D-cycloserine
Enrollment 4
Recruitment Details 4 patients were screened, but none was randomized
Pre-assignment Details 4 patients were screened, but no one was randomized
Arm/Group Title Milnacipran Augmented by D-cycloserine Milnacipran Augmented by Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description participants were not randomized. reporting all subjects together.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
No one was randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
46.5  (11.7)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
[1]
Measure Description: Data were not collected
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Brief Pain Inventory
Hide Description average pain over past week on the scale from 0-10. Data were not collected.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients didn't compete the study. Data were not collected.
Arm/Group Title Milnacipran Augmented by D-cycloserine Milnacipran Augmented by Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Only some baseline demographic information were collected. And no subject was randomized. Study terminated.
Adverse Event Reporting Description Adverse events were not monitored/assessed. 0 Participants at Risk.
 
Arm/Group Title Milnacipran Augmented by D-cycloserine Milnacipran Augmented by Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Milnacipran Augmented by D-cycloserine Milnacipran Augmented by Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Milnacipran Augmented by D-cycloserine Milnacipran Augmented by Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Milnacipran Augmented by D-cycloserine Milnacipran Augmented by Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Alla Landa PhD
Organization: New York State Psychiatric Institute
Phone: 6467746717
EMail: AL2898@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Alla Landa, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02687165    
Other Study ID Numbers: 7003
First Submitted: February 16, 2016
First Posted: February 22, 2016
Results First Submitted: February 1, 2020
Results First Posted: June 1, 2020
Last Update Posted: June 1, 2020