Gabapentin and Donepezil Combination on Experimental Human Pain Models (NCT01485185) | Clinical Trial Compass
CompletedPhase 1
Gabapentin and Donepezil Combination on Experimental Human Pain Models
United Kingdom48 participantsStarted 2011-10-11
Plain-language summary
This study will compare the effects of gabapentin alone, and gabapentin + donepezil given together in two types of experimental electrical pain tests in up to 48 healthy male subjects (after 24 recruited in the first cohort an interim analysis will be performed).
The study is a randomized, double blind, placebo controlled, 3 was cross-over design study with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose and higher dose) or gabapentin (lower dose) with donepezil.
Who can participate
Age range18 Years – 55 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male between 18 and 55 years of age inclusive, at the time of signing the informed consent.
✓. Body weight ≥ 50 Kilogram (kg) and BMI within the range 18.5-29.9 Killogram per square meter (kg/m2) (inclusive).
✓. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, psychiatric history, psychiatric evaluation, laboratory tests and cardiac monitoring.
✓. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5x Upper Limit of Normal (ULN)
✓. QT duration corrected for heart rate by Bazett's formula (QTcB) or QT duration corrected for heart rate by Fridericia's formula (QTcF) \< 450 milli second (msec).
Exclusion criteria
✕. The subject has either a previous disease or current medical condition, which as judged by the Investigator, may compromise safety or affect the interpretation of efficacy data.
✕. History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).
✕. Abnormalities in 12-lead Electrocardiogram (ECG)
✕. Systolic blood pressure (BP) below 90 or above 160mm Hg, or diastolic blood pressure below 50 or above 100 millimeters of mercury (mmHg).
✕
What they're measuring
1
Area of pin-prick hyperalgesia
Timeframe: Change from baseline visit to day 14 of treatment sessions
2
Area of touch-evoked allodynia
Timeframe: Change from baseline visit to day 14 of treatment sessions
. History of sensitivity to any of the study medications
✕. History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 millil litre \[ml\]) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
✕. A positive pre-study drug/alcohol screen at the screening visit.
✕. Excessive caffeine drinkers (\~5 or more cups a day) .