Phase 4 N=220 Randomized Triple-blind Treatment

Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

Central Neuropathic Pain

Bottom Line

View on ClinicalTrials.gov: NCT00313820 ↗

Enrolled (actual)

220

Serious AEs

3.7%

Results posted

Oct 2009

Primary outcome: Primary: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) — 4.8; 5.0 scores on scale — p=0.578

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pregabalin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)	4.8; 5.0	0.578
SECONDARY Pain Score as Measured by DPRS	5.6; 6.0; 5.3; 5.8; 5.1; 5.6	0.161
SECONDARY Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint	48; 35; 60; 73	0.087
SECONDARY Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint	26; 22; 82; 86	0.622
SECONDARY Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])	3.6; 4.2; 3.5; 4.0; 3.2; 3.9	0.027 sig
SECONDARY Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only	48.5; 49.5	0.741
SECONDARY Neuropathic Pain Symptom Inventory (NPSI)	2.6; 2.9; 2.7; 2.6; 1.9; 2.1	0.216
SECONDARY Medical Outcome Study (MOS) Sleep Scale	27.1; 31.9; 40.6; 32.9; 11.3; 15.0	0.086
SECONDARY Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep	51; 42; 49; 55	0.201
SECONDARY Hospital Anxiety and Depression Scale (HADS) - ITT Population	5.5; 6.5; 6.7; 6.5	0.015 sig
SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score	0.5; 0.5	0.566
SECONDARY EQ-5D - VAS	65.7; 62.7	0.220
SECONDARY Patient Global Impression of Change (PGIC)	2.9; 3.1	0.144
SECONDARY Clinical Global Impression of Change (CGIC)	2.8; 3.1	0.049 sig
SECONDARY Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold	0.0; -0.1	—
SECONDARY QANeP - Pain Rating Scales	-0.7; -0.5; -0.8; -0.6; -0.2; -0.2	—

Summary

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

Eligibility Criteria

Inclusion Criteria

Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening

Exclusion Criteria

History of dementia or any other severe cognitive impairment
Diabetic Peripheral Neuropathy (DPN)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00313820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.