Low Back PainPhase 2NCT00125528
D-cycloserine in the Management of Chronic Low Back Pain
A Phase 2 study testing D-cycloserine in people with Low Back Pain and Pain, run by Thomas J. Schnitzer at 1 site in United States.
Trial summary
Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management of chronic neuropathic pain. This pilot study will attempt to determine the effect of D-cycloserine in the treatment of chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Pain
- What is being tested?
- D-cycloserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a history of low back pain for a minimum of 6 months with or without radiation of pain to leg or buttocks.
- Must be 18 years of age.
- Must have a visual analogue scale (VAS) pain score >50 mm
- Must be in generally stable health
- 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 accepted, highly effective method of contraception or abstinence and plan to continue either during the course of the study.
- Must be able and willing to read and understand instructions as well as questionnaires
- 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.
Who cannot join
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back.
- Involvement in litigation regarding their back pain or have a disability claim or are receiving workman's compensation or seeking either as a result of their low back pain
- Neurologic disorder, including history of seizures
- Major psychiatric disorder during the past 6 months
- Moderate or severe depression as determined by the Beck Depression Inventory or any active suicidal ideation
Show all 15Show fewer
- Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
- Significant renal disease or severe renal insufficiency
- History of, or current, substance abuse/dependence including alcohol
- Significantly abnormal laboratory values
- Pregnant or lactating at any time during the course of the study
- Known sensitivity to D-cycloserine
- Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
- In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
- Any change in medication for back pain in the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management of chronic neuropathic pain. This pilot study will attempt to determine the effect of D-cycloserine in the treatment of chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of chronic low back pain and to determine which pain measurement scales are best at measuring the efficacy of treatment.
Read the detailed description
Human brain imaging studies indicate that the medial prefrontal cortex activity can predict more than 80% of the variance of chronic back pain intensity. Therefore, the investigators have hypothesized that modulation of brain activity at this site should result in analgesia. D-cycloserine has been shown to potentiate conditioned fear extinction. Based on this the investigators hypothesize that chronic neuropathic pain (back pain with radiculopathy) is partially mediated or potentiated by decreased ability to extinguish the pain memory, which the investigators hypothesize to be mediated through reward/aversion brain circuitry, and specifically through medial prefrontal cortex. They have tested this idea in pre-clinical studies and demonstrated that rats with neuropathic pain show analgesia over the long-term when treated with D-cycloserine. In humans with chronic back pain, the investigators hypothesize that D-cycloserine will enhance extinction of back pain which in turn should result in reduced emotional relevance of the pain, that is reduced suffering. It is quite possible that the overall intensity of the back pain will be unaffected, however, the associated suffering will be significantly attenuated.
This will be a double-blind, randomized, parallel group escalating dose study comparing D-cycloserine twice a day (bid) with placebo bid in patients with chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 12 weeks with study drug: 50 mg bid DCS or matching placebo for the first 4 weeks, then 100mg bid DCS or matching placebo for 4 weeks and finally 200mg bid DCS or matching placebo for 4 weeks. Assessments of efficacy and safety will be undertaken every 2 weeks using standard, validated instruments to evaluate change in pain, function, quality of life and adverse events.
- Conditions
- Low Back Pain, Pain
- Being tested
- D-cycloserine, placebo
- Keywords
- chronic pain, low back pain, D-cycloserine
- Medical subject headings
- Low Back Pain, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
placeboDrug
placebo bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | D-cycloserine 50mg bid/100mg bid/200 mg bid Receives: Drug: D-cycloserine |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale (NRS-11)
Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.
Measured: 6 weeks
Secondary outcomes (1)
McGill Pain Questionnaire (MPQ)
Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas J. Schnitzer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, M.D., Ph.D., Principal investigator, Northwestern UniversityVania Apkarian, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125528
- Sponsor's protocol ID
- A1159
- Status last verified
- Dec 2016
- First submitted
- 29 Jul 2005
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schnitzer TJ, Torbey S, Herrmann K, Kaushal G, Yeasted R, Vania Apkarian A. A randomized placebo-controlled pilot study of the efficacy and safety of D-cycloserine in people with chronic back pain. Mol Pain. 2016 Nov 15;12:1744806916678627. doi: 10.1177/1744806916678627. Print 2016.
PubMed 27852965
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00125528
- Acronym / sponsor ID
- A1159
- Conditions
- Low Back Pain, Pain
- Keywords
- chronic pain, low back pain, D-cycloserine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Thomas J. SchnitzerUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management of chronic neuropathic pain. This pilot study will attempt to determine the effect of D-cycloserine in the treatment of chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of chronic low back pain and to determine which pain measurement scales are best at measuring the efficacy of treatment.
Detailed description
Human brain imaging studies indicate that the medial prefrontal cortex activity can predict more than 80% of the variance of chronic back pain intensity. Therefore, the investigators have hypothesized that modulation of brain activity at this site should result in analgesia. D-cycloserine has been shown to potentiate conditioned fear extinction. Based on this the investigators hypothesize that chronic neuropathic pain (back pain with radiculopathy) is partially mediated or potentiated by decreased ability to extinguish the pain memory, which the investigators hypothesize to be mediated through reward/aversion brain circuitry, and specifically through medial prefrontal cortex. They have tested this idea in pre-clinical studies and demonstrated that rats with neuropathic pain show analgesia over the long-term when treated with D-cycloserine. In humans with chronic back pain, the investigators hypothesize that D-cycloserine will enhance extinction of back pain which in turn should result in reduced emotional relevance of the pain, that is reduced suffering. It is quite possible that the overall intensity of the back pain will be unaffected, however, the associated suffering will be significantly attenuated.
This will be a double-blind, randomized, parallel group escalating dose study comparing D-cycloserine twice a day (bid) with placebo bid in patients with chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 12 weeks with study drug: 50 mg bid DCS or matching placebo for the first 4 weeks, then 100mg bid DCS or matching placebo for 4 weeks and finally 200mg bid DCS or matching placebo for 4 weeks. Assessments of efficacy and safety will be undertaken every 2 weeks using standard, validated instruments to evaluate change in pain, function, quality of life and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: D-cycloserineD-cycloserine 50mg bid/100mg bid/200 mg bid |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have a history of low back pain for a minimum of 6 months with or without radiation of pain to leg or buttocks.
- Must be 18 years of age.
- Must have a visual analogue scale (VAS) pain score >50 mm
- Must be in generally stable health
- Must be willing to abstain from drinking alcohol during the course of the study.
Key exclusion criteria (15 listed)
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back.
- Involvement in litigation regarding their back pain or have a disability claim or are receiving workman's compensation or seeking either as a result of their low back pain
- Neurologic disorder, including history of seizures
- Major psychiatric disorder during the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserineD-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid | Drug | 1 |
| placeboplacebo bid | Drug | 2 |
Primary outcome
Change in Numeric Rating Scale (NRS-11)
Time frame: 6 weeks
Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.
1 secondary outcome
McGill Pain Questionnaire (MPQ)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27852965Schnitzer TJ, Torbey S, Herrmann K, Kaushal G, Yeasted R, Vania Apkarian A. A randomized placebo-controlled pilot study of the efficacy and safety of D-cycloserine in people with chronic back pain. Mol Pain. 2016 Nov 15;12:1744806916678627. doi: 10.1177/1744806916678627. Print 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Schnitzer, M.D., Ph.D. principal investigator
Northwestern University
Vania Apkarian, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine in people with Low Back Pain and Pain, run by Thomas J. Schnitzer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Rating Scale (NRS-11) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.