- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951105
Effect of L-dopa In Subacute Back Pain Population
Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female, over the age of 18 years, (no racial/ethnic restrictions)
- Must have a history of low back pain for a minimum of 4 weeks and a maximum of 12 weeks with signs and symptoms of radiculopathy: positive straight leg raising test with dermatomal radiation and/or myotomal weakness and/or reflex asymmetry; pain must radiate into buttock or below
- Must have a high risk phenotype for chronification of back pain (evaluated at baseline T1-MRI, DTI-MRI, and fMRI scans)
- Must have an average pain score over a 5 day period (average of ~15 measures on smartphone app) immediately preceding the baseline visit of ≥ 5 (on a 0-10 NRS) at the baseline visit
- Must be willing to read and able to understand instructions as well as 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
Exclusion Criteria:
- Previous (distinct) episodes of back pain onset (more than 3 distinct episodes of back pain lasting for a total of more than 4 weeks) in the previous year
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, chronic spinal stenosis, prior back surgery and history of tumor of the spine
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills
- Other comorbid chronic pain conditions such as fibromyalgia or neuropathic pain secondary to diabetes or post-herpes zoster
- Chronic neurologic conditions, including Parkinson's disease, Alzheimer's disease, and other conditions associated with dementia
- Significant other medical disease such as congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
- Diabetes Type I or Type II
- History of glaucoma or narrow angle glaucoma
- Presence of undiagnosed skin lesions or history of melanoma
- Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease
- History of myocardial infarction with residual cardiac arrhythmia
- History of gastrointestinal bleeding or peptic ulcer
- Diagnosis of current depression (assessed via BDI, total > 28 are excluded) or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months
- Use of therapeutic doses of antidepressant medications (i.e., tricyclic antidepressants, SSRIs, SNRIs; low doses used only in the evening for sleep will be allowed if dose is not changed)
- Current use of recreational drugs or recent history of alcohol abuse (pattern of drinking having social, financial or physical consequences) or drug abuse
- Any change in medication for back pain in the last 30 days
- High dose opioid prophylaxis, defined as > 50mg morphine equivalent/day
- Use of MAOIs, currently or within the past 2 weeks
- Prior use of Levodopa
- Use of any of the following drugs: bromocryptine, linezolid, metoclopramide, phenothiazines,promethazine/codeine, isoniazid, rifampin, pyrazinamide
- Oral iron supplementation
Contraindications to use of study product, based on any of the following:
- Hypersensitivity to Carbidopa/Levodopa or other constituents of the Carbidopa/Levodopa capsules
- Hypersensitivity to lactose or other constituents of the placebo capsules
- Hypersensitivity to Naproxen or other constituents of the Naproxen capsules
- Hypersensitivity to Acetaminophen or other constituents of the Acetaminophen tablets
- Currently taking Levodopa or dopaminergic drugs
- Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of their low back pain
- In the judgment of the investigator, unable or unwilling to follow protocol and instructions
- Intra-axial implants (e.g. spinal cord stimulators or pumps)
- All exclusion criteria for MR safety: any metallic implants, pacemaker, brain or skull abnormalities, tattoos on large body parts, and claustrophobia
- Pregnancy or inability to use an effective method of birth control in sexually active men and women while taking the study drug and for one week thereafter. Barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUD's), hormonal contraceptives, oral contraceptive pills, surgical sterilization, and complete abstinence are examples of effective methods of contraception.
- Following laboratory abnormalities: liver function tests (SGOT/SGPT) greater than twice the upper limit of normal; unexplained anemia (Hgb <9 g/dL); evidence of renal insufficiency (creatinine >upper limit of normal) or any other abnormality that the principal investigator feels puts the subject at risk during the study
- History of chronic opioid use for pain management.
- Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Observation
Individuals identified as having a recovering phenotype (SBPp) will be assigned to the observational arm and will be asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
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Active Comparator: Carbidopa/Levodopa & Naproxen
Individuals identified as having a persisting phenotype (SBPr) will be treated with Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response TID throughout the 12 week treatment period. Naproxen (250mg) capsules will be administered orally, one capsule TID, throughout the 12 week treatment period. |
Take one 250mg naproxen tablet three times a day for 12 weeks.
Other Names:
12.5mg/50mg Carbidopa/Levodopa, administered orally as capsules, will be titrated up to TID over one week and then continued at that level for 4 weeks.
If at the end of this initial 4 week period the participant has "responded," the subject will be maintained on that dose for the duration of the treatment period (12 weeks total).
If there has not been a response, the dose will be increased to 25mg/100mg Carbidopa/Levodopa TID for the following 4 weeks at which time the pain status will be re-evaluated.
If a response has occurred, that dose will be maintained in a blinded manner for the following 4 weeks of treatment; if not, further dose-titration will occur to 50mg/200mg Carbidopa/Levodopa TID for the final 4 weeks.
If a subject experiences an AE at higher doses, then the subject will be given the next lower dose that s/he was able to tolerate and then be maintained on that dose for the remainder of the 12 week dosing period.
Other Names:
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Placebo Comparator: Placebo & Naproxen
Individuals identified as having a persisting phenotype (SBPr) will be treated with placebo capsule plus 250mg naproxen tablet three times a day for 12 weeks.
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Take one 250mg naproxen tablet three times a day for 12 weeks.
Other Names:
Take two placebo capsules three times a day for 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale
Time Frame: 6 months
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Primary outcome is 20% reduction in pain intensity at p<0.1 based on pain ratings during 1 week prior to treatment and last week of study participation (at ~6months)
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment
Time Frame: 6 months
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Residual pain is computed based on pain ratings from the week prior to treatment and last week of study participation (at ~6months)
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Apkar Apkarian, PhD, Northwestern University Feinberg School of Medicine
- Principal Investigator: Thomas J Schnitzer, Northwestern University Feinberg School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Immunologic Factors
- Dopamine Agonists
- Dopamine Agents
- Adjuvants, Immunologic
- Gout Suppressants
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Naproxen
- Carbidopa
- Carbidopa, levodopa drug combination
Other Study ID Numbers
- STU00081444
- R01DE022746 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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