Back to resultsStudy of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain (PhyDoNe)
Primary Purpose
Healthy Volunteers, Patients Suffering of Peripheral Neuropathic Pain
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Neuropathic pain
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy Volunteers focused on measuring Neuropathic pain
Eligibility Criteria
Inclusion Criteria:
neuropathic patients group
- Patient suffering of peripheral neuropathic pain
- 18 years old women or men at least
Exclusion Criteria:
• Healthy volunteers
- 18 years old women or men at least
Sites / Locations
- Chu Clermont-Ferrand
Outcomes
Primary Outcome Measures
Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT01053845
First Posted
January 19, 2010
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Grünenthal GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01053845
Brief Title
Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain
Acronym
PhyDoNe
Official Title
Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Grünenthal GmbH
4. Oversight
5. Study Description
Brief Summary
Several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy.
The purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain.
Detailed Description
Prospective study with comparison groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Patients Suffering of Peripheral Neuropathic Pain
Keywords
Neuropathic pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Neuropathic pain
Intervention Description
to study the working of down inhibitor bundle at patients suffering of neuropathic pain
Primary Outcome Measure Information:
Title
Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
neuropathic patients group
Patient suffering of peripheral neuropathic pain
18 years old women or men at least
Exclusion Criteria:
• Healthy volunteers
18 years old women or men at least
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle Pickering, Dr
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain
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