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

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ClinicalTrials.gov Identifier: NCT00313820
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : October 9, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
Pfizer

April 10, 2006
April 12, 2006
September 8, 2009
October 9, 2009
October 15, 2009
August 2006
September 2008   (Final data collection date for primary outcome measure)
Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) [ Time Frame: Up to Week 12 ]
Weekly Mean Pain Score
Complete list of historical versions of study NCT00313820 on ClinicalTrials.gov Archive Site
  • Pain Score as Measured by DPRS [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ]
  • Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ]
  • Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ]
  • Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS]) [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ]
  • Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only [ Time Frame: Week 12 ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 12 ]
  • Medical Outcome Study (MOS) Sleep Scale [ Time Frame: Week 12 ]
  • Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep [ Time Frame: Week 12 ]
  • Hospital Anxiety and Depression Scale (HADS) - ITT Population [ Time Frame: Week 12 ]
  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Week 12 ]
  • EQ-5D - VAS [ Time Frame: Week 12 ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ]
  • Clinical Global Impression of Change (CGIC) [ Time Frame: Week 12 ]
  • Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold [ Time Frame: Baseline, Week 12 ]
  • QANeP - Pain Rating Scales [ Time Frame: Baseline, Week 12 ]
  • 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 ScaleHospital 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.
Not Provided
Not Provided
 
Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group 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)
Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Central Neuropathic Pain
  • Drug: Pregabalin
    Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
  • Drug: Placebo
    Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
  • Active Comparator: Pregabalin
    The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
226
September 2008
September 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   China,   Hong Kong,   India,   Indonesia,   Korea, Republic of,   Malaysia,   Pakistan,   Philippines,   Taiwan,   Thailand
 
 
NCT00313820
A0081063
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP