Condition category
Nervous System Diseases
Date applied
28/02/2007
Date assigned
01/05/2007
Last edited
05/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Klaus Leenders

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Hanzeplein 1
Groningen
9700 RB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16901

Study information

Scientific title

Acronym

COXPKPD (COX-2 inhibition monitored by PK11195 in Parkinson's Disease)

Study hypothesis

Celecoxib inhibits cerebral activated microglia in Parkinson's disease

Ethics approval

Medical Ethics Review Committee of the University Medical Center Groningen. Approval pending as of 28 February 2007.

Study design

Open, non-randomised, non-placebo controlled, pilot phase trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Parkinson's disease

Intervention

Interventions amended as of 05/09/2007:
All participants will receive celecoxib oral medication of 100 mg daily for 1 month.

Interventions provided at time of registration:
Celecoxib oral medication of 100 mg daily for 1 month.

Intervention type

Drug

Phase

Not Specified

Drug names

Celecoxib

Primary outcome measures

One baseline and one follow-up Positron Emission Tomography (PET) scan (PK11195) and one Magnetic Resonance Imaging (MRI) scan will be performed to assess the reduction of specific cerebral radiotracer uptake (volume of distribution according to Logan graphical method) after celecoxib.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Early Parkinson's disease patients
2. Hoehn and Yahr Parkinson's Disease Rating Scale (HY) 1 - 2

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Gastrointestinal diseases

Recruitment start date

01/04/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

Hanzeplein 1
Groningen
9700 RB
Netherlands
k.l.leenders@neuro.umcg.nl

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Center Groningen (UMCG) Neurology department deparmental funding (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stichting International Parkinson Fonds (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes