Efficacy Of Pregabalin In Subjects With Post-Stroke Pain

Efficacy of pregabalin in subjects with post-stroke pain.

Official Title

A 13-Week, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP).

Conditions

Central Nervous System Disorders
Cerebrovascular Accident
Pain

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Weekly Mean Pain Score

Secondary Outcome Measures:

• Weekly mean pain score from Daily Pain Diary
• Proportion of subjects with at least a 30% and 50% reduction in mean pain score at endpoint as compared with baseline.
• Quantitative Assessment of Neuropathic Pain (QANeP)
• Neuropathic Pain Symptom Inventory (NPSI-symptoms of NeP; Bouhasira et al. in Pain, 2004).
• Weekly mean sleep interference score from Daily Sleep Diary.
• Medical Outcome Study (MOS) Sleep Scale
• Hospital Anxiety and Depression Scale (HADS)
• Short Form-McGill Pain Questionnaire, [SF-MPQ (VAS)] – Part B only.
• EuroQOL (EQ-5D) Health State Profile and Visual Analogue Scale (VAS).
• Clinical Global Impression of Change (CGIC)
• Patient Global Impression of Change (PGIC)
• Safety and tolerability as measured by the assessment of adverse events, vital signs, physical and neurological examinations, clinical laboratory tests and electrocardiogram.

Study Start

August 2006

Eligibility & Criteria

Ages Eligible for Study: 18 Years and above
Genders Eligible for Study: Both 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).

Total Enrolment

226

Contact Details

New South Wales
Pfizer Investigational Site, Warrawong, New South Wales, Australia; recruiting
Pfizer Investigational Site, St Leonards, New South Wales, Australia; recruiting
Pfizer Investigational Site, East Gosford, New South Wales, Australia; recruiting
Pfizer Investigational Site, Darlinghurst, New South Wales, Australia; recruiting
Queensland
Pfizer Investigational Site, Herston, Queensland, Australia; recruiting
Victoria
Pfizer Investigational Site, Footscray, Victoria, Australia; recruiting
Western Australia
Pfizer Investigational Site, Perth, Australia; recruiting