A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing

A Randomized Double-Blind, Placebo-Controlled, Crossover Study To Assess The Reproducibility And The Effect Of Gabapentin On Quantitative Sensory Testing In Neuropathic Pain Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00674687

Enrollment

Registered

2008-05-08

Start date

2004-07-31

Completion date

2006-06-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia, Neuralgia, Postherpetic

Brief summary

The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.

Interventions

DRUG2-weeks placebo then gabapentin

Placebo for 2 weeks followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 1 week

DRUG1-week placebo then gabapentin

Placebo for 1 week followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Neuropathic pain of peripheral origin as a consequence of either post-herpetic neuralgia or post-traumatic neuropathic pain * Well-defined skin area of mechanical allodynia to punctate (von Frey filament) stimuli * Pain intensity score of ≥ 4/10 for von Frey filament-evoked allodynia at the skin area

Exclusion criteria

* Patients who have undergone neurolytic or neurosurgical therapy, including skin excisions, for neuropathic pain * Patients who have trigeminal neuralgia, central pain, chronic radiculopathy, or peripheral neuropathy of non-mechanical or unknown origin * Patients with any other co-existing pain which cannot be differentiated from the neuropathic pain of peripheral origin

Design outcomes

Primary

Measure	Time frame
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)	Weeks 2 and 4

Secondary

Measure	Time frame
Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)	Weeks 2 and 4
Pressure pain tolerance threshold	Weeks 2 and 4
Pain NRS scores for pressure pain	Weeks 2 and 4
Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)	Weeks 2 and 4
Tactile threshold	Week 4
Pressure pain detection threshold	Weeks 2 and 4
Area of punctate and dynamic (soft and coarse brush) allodynia	Weeks 2 and 4
Pain NRS score for punctate allodynia	Weeks 2 and 4
Pain NRS scores for temporal summation to punctate stimuli	Weeks 2 and 4
Subject assessed quality of evoked pain for temporal summation to punctate stimuli	Weeks 2 and 4
Subject assessed quality of evoked pain for punctate allodynia	Weeks 2 and 4
Test-day global pain scale	Week 4
Pain diary card	Week 4
Pain NRS score for dynamic brush allodynia (soft brush)	Weeks 2 and 4
Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)	Weeks 2 and 4
Presence of metabonomic biomarkers	Weeks 1 and 4
Physical examination	1 week after 4-week treatment period
Adverse events	Throughout study duration
Clinical laboratory tests	1 week after 4-week treatment period
Subject assessed quality of pressure pain	Weeks 2 and 4
Neuropathic pain scale	Week 4

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026