Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291148
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2006-02-10
Brief Title:
Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
A Comparative Single Center Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis MS Receiving Treatment With Either Pregabalin or Paroxetine
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a comparative drug trial involving patients with clinically definite Multiple Sclerosis and documented neuropathic pain Patients will be randomized to receive treatment with either paroxetine or pregabalin After dose titration participants will complete various pain scale assessments at several points during the study in order to determine the effectiveness of their assigned pain medication
Detailed Description:
General Objective
To determine the effectiveness of drug treatment in the management of MS-induced neuropathic pain
Specific Objectives
Comparatively assess the effectiveness and safety profile of pregabalin Lyrica and paroxetine Paxil in managing MS-induced neuropathic pain
Comparatively assess the effectiveness of pregabalin Lyrica and paroxetine Paxil in improving the quality-of-life associated with MS-induced neuropathic pain
Study Design
A comparative single center randomized open-label study involving patients with multiple sclerosis MS - induced neuropathic pain receiving treatment with either pregabalin Lyrica or paroxetine Paxil
The study will run for approximately one year requiring individual participants involvement for 8 weeks
Participant Selection
Individuals with clinically definite MS presenting with symptoms of neuropathic pain as determined by clinician that express interest in the study will be screened for eligibility
Inclusion Criteria
Patients presenting with symptoms of neuropathic pain as determined by clinician with a minimum VAS pain score of 40mm as determined by a baseline score 0mm no pain 100mm worst pain
Male and female patients between the ages of 18 and 65 years old
Clinically definite multiple sclerosis as defined by clinical history review neurological examination and positive MRI
EDSS scores of 60
No known hypersensitivity to the study medications
Negative serum pregnancy test for all female patients of childbearing age not currently breastfeeding
Not currently treated with pregabalin gabapentin paroxetine or another SSRI
No previous treatment failures with pregabalin or paroxetine
Baseline creatinine clearance Clcr of 50mLmin
No significant hepatic insufficiency
If on other pain medications must be on stable dose for at least 6 months and other medications must not elicit significant drug-drug interactions with study medications
Study Procedures
After obtaining informed consent Visit 1 participants undergo various assessments including painquality-of-life analyses SF-MPQ SF-36 VAS physicalneurological exam and a standard blood test Based on above inclusion criteria participants will be randomized to either Group A paroxetine or Group B pregabalin Participants will be provided with prescriptions for assigned study medications as well as dosing instructions A pain diary consisting of a single VAS scale will be provided to the participants which are to be completed daily upon waking and should be used to rate the individuals average pain over the last 24 hours Dosages of study medications will be titrated slowly over 3 weeks to lower likelihood of adverse events After the three week titration phase participants will return to the clinic Visit 2 for a follow-up Painquality-of-life assessments as at Visit 1 will be completed again at this visit In addition average pain scores will be determined from daily pain diaries Adverse events will be discussed and individual tolerability will be assessed At this point it will be determined if the patient will be maintained at the target dosage or if the dosage will be lowered to accommodate patient tolerability Participants will be maintained at determined maintenance dose for 5 weeks after which they will return to the clinic Visit 3 for a final follow-up assessment Participants will complete final painquality-of-life assessments as well as the Patient-rated Global Impression of Change Adverse events and average pain scores will be reviewed At the conclusion of the 8-week treatment phase participants will have the option of remaining on their current study medication or be tapered off
To determine the effectiveness of drug treatment in the management of MS-induced neuropathic pain
Specific Objectives
Comparatively assess the effectiveness and safety profile of pregabalin Lyrica and paroxetine Paxil in managing MS-induced neuropathic pain
Comparatively assess the effectiveness of pregabalin Lyrica and paroxetine Paxil in improving the quality-of-life associated with MS-induced neuropathic pain
Study Design
A comparative single center randomized open-label study involving patients with multiple sclerosis MS - induced neuropathic pain receiving treatment with either pregabalin Lyrica or paroxetine Paxil
The study will run for approximately one year requiring individual participants involvement for 8 weeks
Participant Selection
Individuals with clinically definite MS presenting with symptoms of neuropathic pain as determined by clinician that express interest in the study will be screened for eligibility
Inclusion Criteria
Patients presenting with symptoms of neuropathic pain as determined by clinician with a minimum VAS pain score of 40mm as determined by a baseline score 0mm no pain 100mm worst pain
Male and female patients between the ages of 18 and 65 years old
Clinically definite multiple sclerosis as defined by clinical history review neurological examination and positive MRI
EDSS scores of 60
No known hypersensitivity to the study medications
Negative serum pregnancy test for all female patients of childbearing age not currently breastfeeding
Not currently treated with pregabalin gabapentin paroxetine or another SSRI
No previous treatment failures with pregabalin or paroxetine
Baseline creatinine clearance Clcr of 50mLmin
No significant hepatic insufficiency
If on other pain medications must be on stable dose for at least 6 months and other medications must not elicit significant drug-drug interactions with study medications
Study Procedures
After obtaining informed consent Visit 1 participants undergo various assessments including painquality-of-life analyses SF-MPQ SF-36 VAS physicalneurological exam and a standard blood test Based on above inclusion criteria participants will be randomized to either Group A paroxetine or Group B pregabalin Participants will be provided with prescriptions for assigned study medications as well as dosing instructions A pain diary consisting of a single VAS scale will be provided to the participants which are to be completed daily upon waking and should be used to rate the individuals average pain over the last 24 hours Dosages of study medications will be titrated slowly over 3 weeks to lower likelihood of adverse events After the three week titration phase participants will return to the clinic Visit 2 for a follow-up Painquality-of-life assessments as at Visit 1 will be completed again at this visit In addition average pain scores will be determined from daily pain diaries Adverse events will be discussed and individual tolerability will be assessed At this point it will be determined if the patient will be maintained at the target dosage or if the dosage will be lowered to accommodate patient tolerability Participants will be maintained at determined maintenance dose for 5 weeks after which they will return to the clinic Visit 3 for a final follow-up assessment Participants will complete final painquality-of-life assessments as well as the Patient-rated Global Impression of Change Adverse events and average pain scores will be reviewed At the conclusion of the 8-week treatment phase participants will have the option of remaining on their current study medication or be tapered off
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None