Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain
1 other identifier
interventional
30
1 country
1
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 our study is to investigate the effect of Pregabalin as a treatment for neuropathic pain in a homogeneous study population, using proton MRS (1H MRS) focusing on four regions of interest (bilateral thalami, rostral anterior cingulated cortex (rACC) and dominant dorsolateral prefrontal cortex (DLPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
Typical duration for not_applicable
1 active site
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
August 10, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 12, 2010
August 1, 2010
1 year
August 10, 2010
August 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cerebral neurobiological effect of pregabaline as treatment for neuropathic pain
We will measure changes in neurotransmitter levels in the brain (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) before and after treatment with pregabaline. Specific interest in ratio GABA/Gln and GABA/Glu: relationship between inhibitory and excitatory neurotransmittors
1 year
Secondary Outcomes (1)
cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline
1 year
Study Arms (2)
Pregabalin
ACTIVE COMPARATORplacebo + pregabalin
PLACEBO COMPARATORInterventions
During each MR Spectroscopy session, we will measure at regions of interest (rACC, both thalami, dominant DLPC) the levels of the following biochemical substances: * gamma-aminobutyric acid (GABA) * glutamate (Glu) * glutamine (Gln) * N-acetylaspartate (NAA) * Choline-containing compounds (Cho) * Creatine plus phophocreatine (total creatine: Cr) * Myo-inositiol (Ins) * Choline (Cho) * Glucose (Glc) * Lactate (Lac)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitair Ziekenhuis Brussellead
- Moens Maartencollaborator
Study Sites (1)
UZ Brussel
Brussels, Brussels Capital, 1090, Belgium
Related Publications (1)
De Jaeger M, Goudman L, Van Schuerbeek P, De Mey J, Keymeulen B, Brouns R, Moens M. Cerebral Biochemical Effect of Pregabalin in Patients with Painful Diabetic Neuropathy: A Randomized Controlled Trial. Diabetes Ther. 2018 Aug;9(4):1591-1604. doi: 10.1007/s13300-018-0460-y. Epub 2018 Jun 27.
PMID: 29951977DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2010
First Posted
August 12, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2012
Last Updated
August 12, 2010
Record last verified: 2010-08