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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 : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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

Condition or disease Intervention/treatment Phase
Central Neuropathic Pain Drug: Pregabalin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) [ Time Frame: Up to Week 12 ]
    Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.


Secondary Outcome Measures :
  1. Pain Score as Measured by DPRS [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ]
    Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.

  2. Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ]
    30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.

  3. Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ]
    50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.

  4. 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 ]
    DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.

  5. Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only [ Time Frame: Week 12 ]
    SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.

  6. Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 12 ]
    NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.

  7. Medical Outcome Study (MOS) Sleep Scale [ Time Frame: Week 12 ]
    MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

  8. Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep [ Time Frame: Week 12 ]
    MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.

  9. Hospital Anxiety and Depression Scale (HADS) - ITT Population [ Time Frame: Week 12 ]
    HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

  10. Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Week 12 ]
    EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  11. EQ-5D - VAS [ Time Frame: Week 12 ]
    EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

  12. Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ]
    PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

  13. Clinical Global Impression of Change (CGIC) [ Time Frame: Week 12 ]
    CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

  14. Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold [ Time Frame: Baseline, Week 12 ]
    QANeP: assessment of sensory threshold: subject responds "yes" when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline).

  15. QANeP - Pain Rating Scales [ Time Frame: Baseline, Week 12 ]
    Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313820


Locations
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Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Pfizer Investigational Site
East Gosford, New South Wales, Australia, 2250
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
Pfizer Investigational Site
Warrawong, New South Wales, Australia, 2502
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia
Australia, Victoria
Pfizer Investigational Site
Footscray, Victoria, Australia, 3011
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia, 6000
China
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100730
Pfizer Investigational Site
Guang Zhou, China, 510180
Pfizer Investigational Site
Shang Hai, China, 200003
Pfizer Investigational Site
Shang Hai, China, 200040
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong
India
Pfizer Investigational Site
Bangalore, India, 560 034
Pfizer Investigational Site
Bangalore, India, 560 054
Pfizer Investigational Site
Chennai, India, 600 010
Pfizer Investigational Site
Lucknow, India, 226 014
Pfizer Investigational Site
New Delhi, India, 110 002
Indonesia
Pfizer Investigational Site
Jakarta, Indonesia, 10430
Pfizer Investigational Site
Surabaya, Indonesia, 60286
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Malaysia
Pfizer Investigational Site
Kuala Lumpur, Malaysia, 59100
Pfizer Investigational Site
Penang, Malaysia, 11600
Pfizer Investigational Site
Selangor, Malaysia, 68100
Pakistan
Pfizer Investigational Site
Karachi, Sindh, Pakistan
Pfizer Investigational Site
Karachi, Pakistan
Philippines
Pfizer Investigational Site
Manila, Philippines, 1000
Pfizer Investigational Site
Manila, Philippines, 1003
Taiwan
Pfizer Investigational Site
Gueishan Shiang, Taoyuan Hsien, Taiwan
Pfizer Investigational Site
Taichung, Taiwan, 407
Pfizer Investigational Site
Taipei, Taiwan, 112
Thailand
Pfizer Investigational Site
Ratchatewee, Bangkok, Thailand, 10400
Pfizer Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00313820    
Other Study ID Numbers: A0081063
First Posted: April 12, 2006    Key Record Dates
Results First Posted: October 9, 2009
Last Update Posted: February 9, 2021
Last Verified: October 2009
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Post-stroke pain, pregabalin
Additional relevant MeSH terms:
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Neuralgia
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs