NCT00291148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 27, 2012

Status Verified

March 1, 2011

Enrollment Period

6.3 years

First QC Date

February 10, 2006

Last Update Submit

July 26, 2012

Conditions

Neuropathic PainMultiple Sclerosis

Keywords

Neuropathic painMultiple Sclerosispregabalinparoxetine

Outcome Measures

Primary Outcomes (1)

  • Pain levels (as determined by weekly Visual Analogue Scale for pain)

    8 weeks

Secondary Outcomes (3)

  • Short-Form 36 health outcomes survey (SF-36)

    8 weeks

  • Short-form McGill Pain Questionnaire (SF MPQ)

    8 weeks

  • Patient-rated Global Impression of Change (PGIC)

    8 weeks

Study Arms (2)

Paroxetine

ACTIVE COMPARATOR
Drug: paroxetine

pregabalin

ACTIVE COMPARATOR
Drug: pregabalin

Interventions

paroxetineDRUG
Paroxetine
pregabalinDRUG
pregabalin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \< 6.0.
  • 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 \> 50mL/min.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Sclerosis Clinic, Health Sciences Centre

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

NeuralgiaMultiple Sclerosis

Interventions

ParoxetinePregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compoundsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Micheal P Namaka, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

  • Dana A Turcotte, BSc Pharm

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 27, 2012

Record last verified: 2011-03

Locations

CA(1)