D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain (NCT03535688) | Clinical Trial Compass
TerminatedPhase 2
D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
Stopped: Insufficient funding to complete the study
United States203 participantsStarted 2018-03-30
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
* Male or female, age 18 years or older, (no racial/ethnic restrictions)
* Must have an average pain score of ≥ 4 (on a 0-10 NRS) over a 5-7 day period (minimum of daily eDiary entries for at least 5 of 7 days) immediately preceding the baseline visit (visit 2)
* Must be willing to read and able to understand instructions as well as patient reported outcomes (PROs)
* Must be in generally stable health
* Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate
* Must be willing to discontinue all pain medications for chronic back pain (listed below) except the study medication and rescue medication provided and not use the following prohibited pain medications throughout the duration of the treatment period
* analgesics including over the counter (OTC) medications
* NSAIDS including OTC medications
* Coxibs
* Opioids
* Muscle relaxants
* Gabapentins including pregabalin and gabapentin
* Must be willing to comply with recording pain, mood, and study treatment adherence twice daily using study eDiary
* Must be willing to abstain from drinking alcohol during the course of the study.
* If female, must be post-menopausal for at least one year or practicing an …