Milnacipran for Lumbosacral Radicular Pain
Condition: Radicular Pain Related to Lumbosacral Disc Disease
MeSH terms: Spinal Diseases
Intervention: Milnacipran; Placebo
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sciatica radiculopathy lumbar disc lumbosacral disc

Summary:

      This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients
      with lumbosacral disc disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a male or female adult outpatient age 18 or older at the time of consent.

          2. Subject experiences chronic (> 6 months) radicular pain at least 5 days a week
             described as sharp or shooting below the level of the knee associated with lumbar or
             sacral disk disease without suspicion of recent injury; remote (>1 year ago) history
             of surgical intervention (e.g. "failed back syndrome") is allowed provided current
             symptoms meet severity criterion.

          3. Subject-rated VAS specifically related to radicular pain > or = 40 mm at screen and
             baseline visits

          4. Subject has an understanding, ability and willingness to fully comply with study
             procedures and restrictions.

          5. Subject has the ability to provide written, personally signed and dated informed
             consent to participate in the study, in accordance with the International Conference
             on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable
             regulations, before completing any study-related procedures.

        Exclusion Criteria:

          1. Subjects unable to complete assessments due to language or cognitive impairment

          2. Subjects treated with antidepressant or anticonvulsant medication within 4 weeks of
             screening visit (6 weeks for fluoxetine).

          3. Subjects taking monoamine oxidase inhibitors

          4. Subjects who have received procedural intervention within 3 months of screen.

          5. Subjects with known sensitivity to milnacipran.

          6. Subjects unable to complete the questionnaires due to language or cognitive
             impairment.

          7. Subjects with a history of bipolar disorder or psychosis as confirmed by the Mini
             International Neuropsychiatric Interview (MINI).

          8. Subject currently has (or had a history within the last 6 months of) a drug dependence
             or substance abuse disorder according to Diagnostic and Statistical Manual for Mental
             Disorders, Text Revision criteria (excluding nicotine).

          9. Subjects who are currently considered a suicide risk, any subject who has previously
             made a suicide attempt or who has a prior history of or are currently demonstrating
             active suicidal ideation.

         10. Subject has any clinically significant electrocardiogram (ECG) or clinically
             significant laboratory abnormality (including a positive urine drug screen) at
             Screening.

         11. Subject has a concurrent chronic or acute illness, disability, or other condition that
             might confound the results of safety assessments administered in the study or that
             might increase risk to the subject. Similarly, the subject will be excluded if he or
             she has any additional condition(s) that in the Investigator's opinion would prohibit
             the subject from completing the study or would not be in the best interest of the
             subject. This would include any significant illness or unstable medical condition that
             could lead to difficulty complying with the protocol.

         12. Subjects who are pregnant or who are nursing

         13. Subjects who do not agree to use adequate and reliable contraception throughout the
             study.

         14. Subject previously completed, discontinued or was withdrawn from this study.

         15. Subject has taken an investigational drug or taken part in a clinical trial within 30
             days prior to Screening.

         16. Subjects with liver disease or reduced liver function

         17. Subjects with obstructive uropathies

         18. Subjects who consume alcohol in amounts viewed by the Investigator to be
             contraindicated

         19. Subjects with uncontrolled narrow angle glaucoma

         20. Subjects with seizure disorders

         21. Subjects with bleeding disorders or use of other medications that may cause bleeding