NCT01053845

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_1 healthy-volunteers

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

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

January 19, 2010

Last Update Submit

July 4, 2014

Conditions

Healthy VolunteersPatients Suffering of Peripheral Neuropathic Pain

Keywords

Neuropathic pain

Outcome Measures

Primary Outcomes (1)

  • Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain.

Interventions

Neuropathic painOTHER

to study the working of down inhibitor bundle at patients suffering of neuropathic pain

Eligibility Criteria

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

You may qualify if:

  • neuropathic patients group
  • Patient suffering of peripheral neuropathic pain
  • years old women or men at least

You may not qualify if:

  • Healthy volunteers
  • years old women or men at least

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gisèle Pickering, Dr

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(1)