Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain

NCT01743976 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: IRB00022107R01NS057594
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuropathic Pain

Keywords

neuropathic pain; diabetic neuropathy; neuropathic pain after back surgery

Outcome Measures

Primary Outcomes (3)

• McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity

  A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.

  baseline

• McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity

  A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.

  Week 8: last week of study drug treatment

• McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity

  A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.

  Week 10: last week of washout

Secondary Outcomes (2)

• Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks

  baseline, week 8 after baseline, and week 10 after baseline

• Number of Days With Rescue Treatment

  Days: baseline, week 8 after baseline, and week 10 after baseline

Study Arms (2)

Donepezil

EXPERIMENTAL

donepezil 5 mg every day

Drug: Donepezil

Placebo

PLACEBO COMPARATOR

Placebo (sugar pill) every day

Drug: Placebo

Interventions

Donepezil DRUG

donepezil 5 mg once daily for 6 weeks

Also known as: Aricept

Donepezil

Placebo DRUG

placebo or sugar pill will be taken once daily for 6 weeks

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetic neuropathy or failed back syndrome with neuropathic symptoms
• Age 18-80
• Taking a stable dose of gabapentin or pregabalin

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27295, United States

Location

MeSH Terms

Conditions

Neuralgia; Diabetic Neuropathies

Interventions

Donepezil; Sugars

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

Early termination leading to small numbers of subjects.

Results Point of Contact

• Title: James C. Eisenach
• Organization: Wake Forest School of Medicine

jimeisenach@gmail.com

336-716-4182

Study Officials

• James C Eisenach, M.D.

  Wake Forest University Health Sciences

  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: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: October 23, 2013
• Study Completion: October 23, 2013
• Last Updated: March 2, 2021
• Results First Posted: November 18, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)