Status:
UNKNOWN
Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
Moens Maarten
Conditions:
Diabetic Neuropathies
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Functional Imaging of the therapeutic effect of Pregabalin in treatment for neuropathic pain in patients with Diabetic Polyneuropathy using proton Magnetic Resonance Spectroscopy (MRS): The aim of ou...
Detailed Description
spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex measurements: gamma-aminobutyric acid (GABA) glutamate (Glu) glutamin...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients with painful DPN
- Patient willing to provide informed consent
- Type 1 or type 2 diabetes with HbA1c ≤ 11%
- Stable antidiabetic medication for 30 days prior to randomization
- Duration of painful DPN ≥ 3 months
- Visual analogue scale (VAS) score ≥ 4
Exclusion
- Creatinine clearance ≤ 60mL/min
- Presence of other clinically significant or disabling chronic pain condition
- Active malignancy
- Evidence of an active disruptive psychiatric disorder or other known condition that might influence the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- Life expectancy less than 1 year
- Existing or planned pregnancy
- Extreme fear for entering MRI
- General contraindication for MRI (pacemaker, etc…)
- Patients participating in other clinical trials
- Age \<18 years
- Prior use of potential retinotoxins
- Prohibited medications without proper wash-out period (\>7days, depending on the type of medication):
- medications and supplements commonly used for relief of neuropathic pain
- antiepileptics
- antidepressants (except for stable regiments of SSRIs for treatment of anxiety or depression)
- NSAID
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01180608
Start Date
September 1 2010
End Date
September 1 2012
Last Update
August 12 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Brussel
Brussels, Brussels Capital, Belgium, 1090