Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging

October 12, 2016 updated by: Pierre Fabre Medicament
The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Centre d'Investigation Clinique (CIC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Male right-handed*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form

Exclusion Criteria:

Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.

History of obstructive voiding symptoms, including urinary retention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: F2695
Single dose - 2 capsules / Day on Day 1 and Day 8
Drug: F2695
Placebo Comparator: placebo
Single dose - 2 capsules / Day on Day 1 and Day 8
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor system cortical areas activation magnitude during a paced motor task.
Time Frame: 1 day (Period 1/Day +1, Period 2/Day +8)
  1. Location coordinates (x,y,z),
  2. Voxel cluster size expressed in terms number of voxels,
  3. Intensity as measured with a Z-score
1 day (Period 1/Day +1, Period 2/Day +8)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs) as a measure of safety and tolerability
Time Frame: up to 2 weeks
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

  • Principal Investigator: François Chollet, Hôpital Purpan CHU TOULOUSE, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • F02695LP105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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