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Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain

Primary Purpose

Diabetic Neuropathies, Pain

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

MR Spectroscopy

About this trial

This is an interventional basic science trial for Diabetic Neuropathies focused on measuring neuropathic pain, Diabetic Polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

UZ Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin

placebo + pregabalin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline

A possible dose dependent effect of treatment with Pregabalin on cerebral neurochemical changes (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)) and clinical effects (pain and quality of life scales) will be evaluated

Full Information

NCT ID

NCT01180608

First Posted

August 10, 2010

Last Updated

August 11, 2010

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Moens Maarten

1. Study Identification

Unique Protocol Identification Number

NCT01180608

Brief Title

Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain

Official Title

Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain in Patients With Diabetic Polyneuropathy Using Proton MR Spectroscopy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Moens Maarten

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

spectrum measurements at: thalamus left thalamus right rostral anterior cingulated cortex dominant dorsolateral prefrontal cortex measurements: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathies, Pain

Keywords

neuropathic pain, Diabetic Polyneuropathy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pregabalin

Arm Type

Active Comparator

Arm Title

placebo + pregabalin

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

MR Spectroscopy

Intervention Description

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)

Primary Outcome Measure Information:

Title

cerebral neurobiological effect of pregabaline as treatment for neuropathic pain

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

cerebral neurobiological changes in relationship with dose dependent therapeutic effect of treatment with pregabaline

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maarten Moens, MD

Phone

0032478884047

mtmoens@gmail.com

Facility Information:

Facility Name

UZ Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maarten Moens, MD

First Name & Middle Initial & Last Name & Degree

Maarten Moens, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

29951977

Citation

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.

Results Reference

derived

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Functional Imaging of the Therapeutic Effect of Pregabalin in Treatment for Neuropathic Pain

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