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Trial record 33 of 332 for:    DONEPEZIL

Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01743976
Recruitment Status : Active, not recruiting
First Posted : December 6, 2012
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date December 28, 2018
Actual Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Pain Intensity [ Time Frame: 10 weeks ]
McGill short form pain questionnaire (SF MPQ)will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication. The visual analog scale (VAS) pain rating will serve as the study's primary outcome measure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01743976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2012)
  • Change from baseline disability measures at 10 weeks [ Time Frame: 10 weeks ]
    The McGill short form pain questionnaire (SF MPQ) and the Profile of Mood States-Short Form (POMS-SF) will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication. Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.
  • Change from baseline psychometric measures at 10 weeks [ Time Frame: 10 weeks ]
    The Profile of Mood States-Short Form (POMS-SF) will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication. Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.
  • Change from baseline global assessments at 10 weeks [ Time Frame: 10 weeks ]
    The McGill short form pain questionnaire (SF MPQ) and the Profile of Mood States-Short Form (POMS-SF) will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication. Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.
  • Change from baseline rescue medication use at 10 weeks [ Time Frame: 10 weeks ]
    Questionnaires detailing the amount of rescue pain medications will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication. Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
Official Title  ICMJE Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE
  • Drug: Donepezil
    donepezil 5 mg once daily for 6 weeks
    Other Name: Aricept
  • Drug: Placebo
    placebo or sugar pill will be taken once daily for 6 weeks
    Other Name: sugar pill
Study Arms  ICMJE
  • Experimental: Donepezil
    donepezil 5 mg every day
    Intervention: Drug: Donepezil
  • Placebo Comparator: Placebo
    Placebo (sugar pill) every day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
33
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743976
Other Study ID Numbers  ICMJE IRB00022107
R01NS057594 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: James C Eisenach, M.D. Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP