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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00313820
Registration number
NCT00313820
Ethics application status
Date submitted
10/04/2006
Date registered
12/04/2006
Date last updated
9/02/2021
Titles & IDs
Public title
Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
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Scientific 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)
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Secondary ID [1]
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A0081063
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Central Neuropathic Pain
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pregabalin
Treatment: Drugs - Placebo
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.
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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Week 12
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Secondary outcome [1]
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Pain Score as Measured by DPRS
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Assessment method [1]
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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.
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Timepoint [1]
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Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
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Secondary outcome [2]
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Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Week 12
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Secondary outcome [3]
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Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 12
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Secondary outcome [4]
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Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
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Assessment method [4]
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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.
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Timepoint [4]
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Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
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Secondary outcome [5]
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Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only
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Assessment method [5]
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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.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Neuropathic Pain Symptom Inventory (NPSI)
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Assessment method [6]
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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.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Medical Outcome Study (MOS) Sleep Scale
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Assessment method [7]
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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.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep
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Assessment method [8]
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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.
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Hospital Anxiety and Depression Scale (HADS) - ITT Population
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Assessment method [9]
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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.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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Assessment method [10]
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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.
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Timepoint [10]
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Week 12
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Secondary outcome [11]
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EQ-5D - VAS
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Assessment method [11]
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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.
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Timepoint [11]
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Week 12
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Secondary outcome [12]
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Patient Global Impression of Change (PGIC)
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Assessment method [12]
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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).
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Clinical Global Impression of Change (CGIC)
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Assessment method [13]
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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).
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Timepoint [13]
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Week 12
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Secondary outcome [14]
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Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold
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Assessment method [14]
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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).
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Timepoint [14]
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Baseline, Week 12
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Secondary outcome [15]
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QANeP - Pain Rating Scales
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Assessment method [15]
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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).
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Timepoint [15]
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Baseline, Week 12
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Eligibility
Key inclusion criteria
- Positive history of clinical stroke at least 4 months prior to randomization CPSP--3
months prior to screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of dementia or any other severe cognitive impairment
- Diabetic Peripheral Neuropathy (DPN)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2008
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Sample size
Target
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Accrual to date
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Final
220
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Darlinghurst
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Recruitment hospital [2]
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Pfizer Investigational Site - East Gosford
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Recruitment hospital [3]
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Pfizer Investigational Site - St Leonards
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Recruitment hospital [4]
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Pfizer Investigational Site - Warrawong
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Recruitment hospital [5]
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Pfizer Investigational Site - Herston
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Recruitment hospital [6]
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Pfizer Investigational Site - Footscray
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Recruitment hospital [7]
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Pfizer Investigational Site - Perth
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2250 - East Gosford
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2502 - Warrawong
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Recruitment postcode(s) [5]
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- Herston
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Recruitment postcode(s) [6]
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3011 - Footscray
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Recruitment postcode(s) [7]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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China
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State/province [2]
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Guang Zhou
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Country [3]
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China
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State/province [3]
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Shang Hai
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Hong Kong
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State/province [4]
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New Territories
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India
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State/province [5]
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Bangalore
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Country [6]
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India
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Chennai
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Country [7]
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India
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Lucknow
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India
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State/province [8]
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New Delhi
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Indonesia
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State/province [9]
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Jakarta
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Country [10]
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Indonesia
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State/province [10]
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Surabaya
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul
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Country [12]
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Malaysia
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State/province [12]
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Kuala Lumpur
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Country [13]
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Malaysia
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State/province [13]
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Penang
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Malaysia
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State/province [14]
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Selangor
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Pakistan
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Sindh
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Pakistan
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Karachi
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Philippines
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Manila
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Taiwan
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State/province [18]
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Taoyuan Hsien
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Country [19]
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Taiwan
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State/province [19]
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Taichung
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Country [20]
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Taiwan
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State/province [20]
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Taipei
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Country [21]
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Thailand
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State/province [21]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with
central post stroke pain (CPSP)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00313820
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00313820
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