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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Secondary ID [1] 0 0
A0081063
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Neuropathic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
Timepoint [1] 0 0
Up to Week 12
Secondary outcome [1] 0 0
Pain Score as Measured by DPRS
Timepoint [1] 0 0
Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
Secondary outcome [2] 0 0
Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
Timepoint [4] 0 0
Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
Secondary outcome [5] 0 0
Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Neuropathic Pain Symptom Inventory (NPSI)
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Medical Outcome Study (MOS) Sleep Scale
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Hospital Anxiety and Depression Scale (HADS) - ITT Population
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
EQ-5D - VAS
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Patient Global Impression of Change (PGIC)
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Clinical Global Impression of Change (CGIC)
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold
Timepoint [14] 0 0
Baseline, Week 12
Secondary outcome [15] 0 0
QANeP - Pain Rating Scales
Timepoint [15] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
* Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of dementia or any other severe cognitive impairment
* Diabetic Peripheral Neuropathy (DPN)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - East Gosford
Recruitment hospital [3] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Warrawong
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Footscray
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - East Gosford
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2502 - Warrawong
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guang Zhou
Country [3] 0 0
China
State/province [3] 0 0
Shang Hai
Country [4] 0 0
Hong Kong
State/province [4] 0 0
New Territories
Country [5] 0 0
India
State/province [5] 0 0
Bangalore
Country [6] 0 0
India
State/province [6] 0 0
Chennai
Country [7] 0 0
India
State/province [7] 0 0
Lucknow
Country [8] 0 0
India
State/province [8] 0 0
New Delhi
Country [9] 0 0
Indonesia
State/province [9] 0 0
Jakarta
Country [10] 0 0
Indonesia
State/province [10] 0 0
Surabaya
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Malaysia
State/province [12] 0 0
Kuala Lumpur
Country [13] 0 0
Malaysia
State/province [13] 0 0
Penang
Country [14] 0 0
Malaysia
State/province [14] 0 0
Selangor
Country [15] 0 0
Pakistan
State/province [15] 0 0
Sindh
Country [16] 0 0
Pakistan
State/province [16] 0 0
Karachi
Country [17] 0 0
Philippines
State/province [17] 0 0
Manila
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taoyuan Hsien
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taichung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
Thailand
State/province [21] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)
Trial website
https://clinicaltrials.gov/study/NCT00313820
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00313820