- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743976
Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigators are currently examining in the laboratory the mechanisms which lead to sprouting of noradrenergic fibers in the spinal cord in models of chronic pain as well as the mechanisms that lead to a novel noradrenergic - cholinergic circuit in the spinal cord. In addition to examining the circumstances which generate this increased capacity for analgesia and the mechanisms by which they occur, investigators will test in this protocol whether approved and experimental treatments for neuropathic pain exploit this increased capacity.
This study is in patients with neuropathic pain taking gabapentin or pregabalin, and will test the clinical relevance of these preclinical data by comparing placebo to the cholinesterase inhibitor. Investigators focus not only on mechanistic hypotheses in the laboratory studies, but also on practical applications, using clinically approved drugs, including gabapentin and pregabalin to activate noradrenergic activity and donepezil (Aricept®), approved for the treatment of Alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase. Each of these drugs may act by mechanisms in addition to those involved in descending noradrenergic inhibition, but investigators hypothesize that the therapeutic strength of their combination relies heavily on this cascade engendered by noradrenergic sprouting and altered α2-adrenoceptor function. The proposed studies will provide critical tests of this hypothesis and critical information to guide more effective clinical therapy of neuropathic pain.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Winston-Salem, North Carolina, United States, 27295
- Wake Forest Baptist Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Donepezil
donepezil 5 mg every day
|
donepezil 5 mg once daily for 6 weeks
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Placebo (sugar pill) every day
|
placebo or sugar pill will be taken once daily for 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
Time Frame: baseline
|
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
Time Frame: Week 8: last week of study drug treatment
|
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
Time Frame: Week 10: last week of washout
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks
Time Frame: baseline, week 8 after baseline, and week 10 after baseline
|
The questionnaire records total mood disturbance.
The scale ranges from 0-100 with a greater number denoting a worse outcome.
|
baseline, week 8 after baseline, and week 10 after baseline
|
Number of Days With Rescue Treatment
Time Frame: Days: baseline, week 8 after baseline, and week 10 after baseline
|
Questionnaires detailing the amount of rescue pain medications will be completed twice daily.
|
Days: baseline, week 8 after baseline, and week 10 after baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- IRB00022107
- R01NS057594 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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