NCT02266966

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
Last Updated

October 13, 2016

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

September 19, 2014

Last Update Submit

October 12, 2016

Conditions

Subject

Outcome Measures

Primary Outcomes (1)

  • Motor system cortical areas activation magnitude during a paced motor task.

    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 Outcomes (1)

  • Incidence of adverse events (AEs) as a measure of safety and tolerability

    up to 2 weeks

Study Arms (2)

F2695

EXPERIMENTAL

Single dose - 2 capsules / Day on Day 1 and Day 8

Drug: F2695

placebo

PLACEBO COMPARATOR

Single dose - 2 capsules / Day on Day 1 and Day 8

Drug: Placebo

Interventions

F2695DRUG
F2695
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique (CIC)

Toulouse, France

Location

Study Officials

  • François Chollet

    Hôpital Purpan CHU TOULOUSE, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 17, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 13, 2016

Record last verified: 2013-12

Locations

FR(1)