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Donepezil

Phase 1

Pain, Neuropathic | Small molecule | Pain |GSK plc|Last Updated: Jun 12, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Donepezil · 1 trial · 1 indication

Phase 1 1
NCT01485185Gabapentin and Donepezil Combination on Experimental Human Pain ModelsPain, Neuropathic
COMPLETED48 Analytics
PHASE1COMPLETED
Gabapentin and Donepezil Combination on Experimental Human Pain Models
Pain, NeuropathicUnlock trial analytics

Study Endpoints

Primary Endpoints

Area of pin-prick hyperalgesia
Change from baseline visit to day 14 of treatment sessions

Change in Area between treatment arms (compared to baseline), measured during the electrical hyperalgesia model using 26 Milli Neuton(mN) von Frey filament

Area of touch-evoked allodynia
Change from baseline visit to day 14 of treatment sessions

Change in Area between treatment arms (compared to baseline), measured during the electrical hyperalgesia model using a cotton bud

Secondary Endpoints

Pain threshold
Change from baseline visit to day 14 of treatment sessions
Ongoing pain intensity rating
Change from baseline visit to day 14 of treatment sessions
Pain Tolerance
Change from baseline visit to day 14 of treatment sessions
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Gabapentin lower dose aloneEXPERIMENTALlow dose
Gabapentin higher dose aloneACTIVE_COMPARATORhigher dose
Gabapentin in combination with donepezilEXPERIMENTALGabapentin lower dose and donepezil
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Gabapentin lower doseDRUGRepeat, oral dose
DonepezilDRUGRepeat, oral dose
Placebo (Dop)OTHERPlacebo to donepezil, Repeat, oral dose
Placebo (Gaba)OTHERPlacebo to gabapentin, Repeat, oral dose
Gabapentin higher doseDRUGRepeat, oral dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male between 18 and 55 years of age inclusive, at the time of signing the informed consent. 2. Body weight ≥ 50 Kilogram (kg) and BMI within the range 18.5-29.9 Killogram per square meter (kg/m2) (inclusive). 3. Healthy as determined by a responsible and experienced physician...

Countries:United Kingdom
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Competitive Landscape -Neuropathic Pain 9 trials (matched to "Pain, Neuropathic")

Frequently asked questions about Donepezil

What is Donepezil used for?

Donepezil is being studied for the treatment of neuropathic pain. It is a small molecule in Phase 1 clinical development. In a completed early-stage trial, it was evaluated in combination with gabapentin on experimental human pain models in healthy volunteers.

Who makes Donepezil?

Donepezil is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug for neuropathic pain.

What phase is Donepezil in?

Donepezil is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not yet approved for any use. It remains investigational and is being studied for its potential in treating neuropathic pain.

What clinical trials is Donepezil in?

Donepezil has one completed clinical trial, NCT01485185, titled "Gabapentin and Donepezil Combination on Experimental Human Pain Models." This Phase 1 study enrolled 48 male participants aged 18 years and older in the United Kingdom and was placebo-controlled and double-blind.

How does Donepezil work?

The specific molecular target of Donepezil is not disclosed in the available clinical trial information. The drug is being investigated for its effects on neuropathic pain, but its mechanism of action has not been detailed in the public trial data.