Effect of L-dopa In Subacute Back Pain Population

PHASE4CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 24, 2015

Primary Completion Date

September 25, 2017

Study Completion Date

September 25, 2017

Conditions
Sub-acute Back Pain
Interventions
DRUG

Naproxen

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

DRUG

Carbidopa/Levodopa

"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."

DRUG

Placebo

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

Trial Locations (1)

60611

Northwestern University Feinberg School of Medicine, Chicago

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

lead

Northwestern University

OTHER

NCT01951105 - Effect of L-dopa In Subacute Back Pain Population | Biotech Hunter | Biotech Hunter