NCT01951105

Brief Summary

This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 24, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2.6 years

First QC Date

September 17, 2013

Results QC Date

June 4, 2019

Last Update Submit

March 2, 2021

Conditions

Sub-acute Back Pain

Keywords

SubacuteBackPainBrainMRI

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale

    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)

    6 months

Secondary Outcomes (1)

  • Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment

    6 months

Study Arms (3)

Observation

NO INTERVENTION

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.

Carbidopa/Levodopa & Naproxen

ACTIVE COMPARATOR

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.

Drug: NaproxenDrug: Carbidopa/Levodopa

Placebo & Naproxen

PLACEBO COMPARATOR

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.

Drug: NaproxenDrug: Placebo

Interventions

NaproxenDRUG

Take one 250mg naproxen tablet three times a day for 12 weeks.

Also known as: Aleve, Anaprox, Antalgin, Apranax, Feminax Ultra, Flanax, Inza, Midol Extended Relief, Nalgesin, Naposin, Naprelan, Naprogesic, Naprosyn, Narocin, Proxen, Soproxen, Synflex, Xenobid
Carbidopa/Levodopa & NaproxenPlacebo & Naproxen
Carbidopa/LevodopaDRUG

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.

Also known as: Sinemet
Carbidopa/Levodopa & Naproxen
PlaceboDRUG

Take two placebo capsules three times a day for 12 weeks.

Also known as: Sugar Pill
Placebo & Naproxen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Reckziegel D, Tetreault P, Ghantous M, Wakaizumi K, Petre B, Huang L, Jabakhanji R, Abdullah T, Vachon-Presseau E, Berger S, Baria A, Griffith JW, Baliki MN, Schnitzer TJ, Apkarian AV. Sex-Specific Pharmacotherapy for Back Pain: A Proof-of-Concept Randomized Trial. Pain Ther. 2021 Dec;10(2):1375-1400. doi: 10.1007/s40122-021-00297-2. Epub 2021 Aug 10.

    PMID: 34374961DERIVED

MeSH Terms

Conditions

Pain

Interventions

Naproxencarbidopa, levodopa drug combinationSugars

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsCarbohydrates

Results Point of Contact

Title
Apkar Vania Apkarian
Organization
Northwestern University
a-apkarian@northwestern.edu
312-503-0404

Study Officials

  • Apkar Apkarian, PhD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

  • Thomas J Schnitzer

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 26, 2013

Study Start

February 24, 2015

Primary Completion

September 25, 2017

Study Completion

September 25, 2017

Last Updated

March 24, 2021

Results First Posted

September 25, 2019

Record last verified: 2021-03

Locations

US(1)