Effect of Thiamphenicol on EAAT2 and Other Biomarkers Fro... | NCT00958503

Studies
Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue

NCT00958503

Sponsor

Psyadon Pharma

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Thiamphenicol
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Aug 12, 2009

First Submission Date that Met QC Criteria

Aug 12, 2009

First Posted Date

Aug 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Name	Class
SGS Life Sciences, a division of SGS Belgium NV	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken from the nasal passages.

Detailed Description

Thiamphenicol has been proposed to increase the levels of the excitatory amino acid transporter 2 (EAAT2) in the nervous tissue. This study evaluated the ability of two weeks of treatment with thiamphenicol to increase EAAT2 in a nasal biopsy as a surrogate of brain nervous tissue.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo	Drug: Placebo
Thiamphenicol	Active Comparator	Active comparator	Drug: Thiamphenicol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thiamphenicol	Drug	750 and 1500 mg/day;tablets	Thiamphenicol	Thiamphenicol, Urfamycine (trade name in Belgium)

Measure	Description	Time Frame
Amount of EAAT2 RNA in nasal biopsy		Two weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal volunteers

Exclusion Criteria:

less than 18 years
older than 55 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard E Chipokin, PhD	Ruxton Pharmaceuticals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SGS Research Unit - Stuivenberg		Antwerp			Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D013839	Thiamphenicol

Ancestor Terms

ID	Term
D002701	Chloramphenicol
D011409	Propylene Glycols
D006018	Glycols
D000438	Alcohols

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Browse Branches

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