D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain
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ClinicalTrials.gov Identifier: NCT03535688 |
Recruitment Status :
Terminated
(Insufficient funding to complete the study)
First Posted : May 24, 2018
Last Update Posted : January 25, 2024
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Sponsor:
Northwestern University
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
Tracking Information | |||||
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First Submitted Date ICMJE | April 3, 2018 | ||||
First Posted Date ICMJE | May 24, 2018 | ||||
Last Update Posted Date | January 25, 2024 | ||||
Actual Study Start Date ICMJE | March 30, 2018 | ||||
Actual Primary Completion Date | May 5, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in Numeric Rating Scale (NRS) pain score 0-10; higher worse [ Time Frame: 12 weeks ] Mean pain levels will be assessed at study baseline and compared to mean pain levels at Week 12 (study efficacy endpoint). Pain will be assessed using an 11-point NRS scale.
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Original Primary Outcome Measures ICMJE |
Change in Numeric Rating Scale (NRS) pain score [ Time Frame: 12 weeks ] Mean pain levels will be assessed at study baseline and compared to mean pain levels at Week 12 (study efficacy endpoint). Pain will be assessed using an 11-point NRS scale.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain | ||||
Official Title ICMJE | D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain | ||||
Brief 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. | ||||
Detailed Description | This is a 26-week, double-blind, randomized, placebo-controlled two-arm parallel-group trial of d-cycloserine, a pharmacological treatment selected based on positive results from previous preclinical and clinical studies, for the treatment of chronic, refractory low back pain (CBP). After a 2-week screening period, individuals will be randomized to receive either 12 weeks of d-cycloserine or placebo and then followed for an additional 12 weeks to evaluate persistence of benefit at study endpoint, 24 weeks after randomization. During the 12-week treatment period, participants will undergo evaluation at baseline and at clinic visits on weeks 2, 6 and 12 after randomization to assess pain, proper treatment use and side effects. During the subsequent 12-week follow-up period, pain and safety will continue to be assessed monthly by phone calls. All patients will also be assessed daily using an electronic diary (eDiary) to record pain and mood. Magnetic resonance imaging (MRI), anatomical MRI, resting state functional MRI (fMRI), diffusion-tensor imaging (DTI) MRI, and arterial spin labeling (ASL) will be performed at baseline and at the end of 12 weeks for individuals completing MRI. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: Triple Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Pinto CB, Bielefeld J, Barroso J, Yip B, Huang L, Schnitzer T, Apkarian AV. Chronic pain domains and their relationship to personality, abilities, and brain networks. Pain. 2023 Jan 1;164(1):59-71. doi: 10.1097/j.pain.0000000000002657. Epub 2022 Apr 20. No abstract available. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
203 | ||||
Original Estimated Enrollment ICMJE |
244 | ||||
Actual Study Completion Date ICMJE | June 6, 2023 | ||||
Actual Primary Completion Date | May 5, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03535688 | ||||
Other Study ID Numbers ICMJE | STU00205398 A-20364 ( Other Grant/Funding Number: Department of Defense ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Thomas J. Schnitzer, Northwestern University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Northwestern University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | United States Department of Defense | ||||
Investigators ICMJE |
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PRS Account | Northwestern University | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |