Tariquidar-ondansetron Combination in Neuropathic Pain

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, randomized, double-blind, placebo controlled, cross-over proof of concept study.

To determine the pharmacokinetics and tolerability of co-administration of 5-HT3R antagonist ondansetron with a P-glycoprotein inhibitor tariquidar, in patients with neuropathic pain.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

1. Age 18-65;

2. Documented diagnosis of neuropathic pain due to damage or disease affecting the peripheral nervous system;

3. At least Probable neuropathic pain grading1;

4. Pain duration >3 months;

5. Average pain intensity ≥4 on 0-10 numerical rating scale (NRS).

Exclusion Criteria:

1. Current pregnancy or lactation;

2. Moderate-severe kidney or liver dysfunction;

3. Active cardiac arrhythmias (non-sinus rhythm), Long QT syndrome, or QTc interval >450msec;

4. Congestive heart failure

5. Abnormal troponin values at screening visit;

6. Current treatment with MAO inhibitors, mirtazapine, SSRI antidepressants, or SNRI medications duloxetine or venlafaxine;

7. Current treatment with tapentadol, tramadol, or fentanyl;

8. Current treatment with P-glycoprotein substrate drugs with narrow therapeutic window, e.g. digoxin;

9. Current treatment with tricyclic antidepressant medications (e.g. amitriptyline, desipramine, imipramine) at a dose >25mg/day;

10. Ongoing use of any of the following medications with known effects on Pgp function:

carbamazepine, phenytoin, phenobarbital, cyclosporine, clarithromycin, erythromycin, ritonavir, verapamil, rifampicin, St. John's wort;

11. Current treatment with QT-prolonging drugs, and drugs known to have a significant interaction with ondansetron or other P-glycoprotein substrates (see section 2.3.3.);

12. Current treatment with anticoagulant drugs;