NCT02138864

Brief Summary

The study purpose is to determine the clinical values of 18F-FP-(+)-DTBZ in the diagnosis of Parkinsonism in patients with carbon monoxide intoxication, regional distribution and its correlation with clinical parameters. This study is expected to be completed in a period of 3 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

May 7, 2014

Last Update Submit

May 28, 2016

Conditions

Carbon Monoxide-induced Parkinsonism

Keywords

carbon monoxide intoxicationParkinsonism18F-DTBZ AV-133

Outcome Measures

Primary Outcomes (1)

  • Assess the regional decline in 18F-DTBZ uptake of Parkinsonism after carbon monoxide intoxication

    This study will assess the brain uptake and distribution of 18F-DTBZ in 25 carbon monoxide intoxication patients with Parkinsonism. For each patient, the PET will be arranged twice, with an interval of 1.5 years.

    up to 3 years

Study Arms (1)

18F-FP-(+)-DTBZ only

EXPERIMENTAL

PET tracer: 18F-FP-(+)-DTBZ

Radiation: 18F-FP-(+)-DTBZ

Interventions

18F-FP-(+)-DTBZRADIATION

no available

18F-FP-(+)-DTBZ only

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 20 years to 65 years.
  • Patients group should fulfilled diagnostic criteria of carbon monoxide intoxication
  • Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm consent)

You may not qualify if:

  • History of developmental disorders, agitated mood or a confused state that prevented either a neuropsychiatric interview or neuroimaging.
  • Unable to stay still in the PET scanner for 30 minutes.
  • History or presence of QTc prolongation. (\>500msec)
  • Pregnancy and breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

MeSH Terms

Conditions

Carbon Monoxide PoisoningParkinsonian Disorders

Interventions

florbenazine F 18

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Study Officials

  • Chiung-Chih Chang, M.D.; Ph.D

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 15, 2014

Study Start

August 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

TW(1)