Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain

• Status: Terminated
• Trial end date: 2013-10-23
• Target enrollment: 0
• Participant gender: All

Summary

Based on laboratory studies, donepezil will improve pain relief more than placebo in patients with chronic neuropathic pain who are currently taking gabapentin or pregabalin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Diagnosis of diabetic neuropathy or failed back syndrome with neuropathic symptoms

• Age 18-80

• Taking a stable dose of gabapentin or pregabalin

Exclusion Criteria:

• Pregnant women or women of child-bearing potential not willing to practice a reliable form of birth control

• Allergy to donepezil or other piperidine derivatives (including fentanyl, alfentanil, sulfentanil, remifentanyl, demerol, tramadol, loperamide, diphenoxylate, betaprodine, alphaprodine, ethopropazine, anileridine, piminodine, 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP),loratadine, fexofenadine

• Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases that, in the opinion of the investigator, would preclude patients from finishing the trial

• Any person with pending litigation

• A history of major psychosis requiring hospitalization within the last three years

• Non-English speaking, illiterate, unable to comprehend consent

• Lack of contact information

• Uncontrolled narrow-angle glaucoma

• Currently being treatment with thioridazine (Mellaril)

• Patients taking opioids will be excluded if they are taking a dosage that exceeds an equivalent of 30 mg of morphine per day

• Patients taking more than one regular (not rescue) medication for pain

• Patients taking donepezil for dementia

• Patients with a baseline pain score less than 2 (0-10 scale) or greater than 8 (0-10) will be excluded