Effect of selective COX-2 inhibition on neuroinflammation in Parkinson's disease
| ISRCTN | ISRCTN59798735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59798735 |
| Protocol serial number | 16901 |
| Sponsor | University Medical Center Groningen (UMCG) (The Netherlands) |
| Funders | University Medical Center Groningen (UMCG) Neurology department deparmental funding (The Netherlands), Stichting International Parkinson Fonds (The Netherlands) |
- Submission date
- 28/02/2007
- Registration date
- 01/05/2007
- Last edited
- 05/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Klaus Leenders
Scientific
Scientific
University Medical Center Groningen (UMCG)
Hanzeplein 1
Groningen
9700 RB
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open, non-randomised, non-placebo controlled, pilot phase trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | COXPKPD (COX-2 inhibition monitored by PK11195 in Parkinson's Disease) |
| Study objectives | Celecoxib inhibits cerebral activated microglia in Parkinson's disease |
| Ethics approval(s) | Medical Ethics Review Committee of the University Medical Center Groningen. Approval pending as of 28 February 2007. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Celecoxib |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Early Parkinson's disease patients 2. Hoehn and Yahr Parkinson's Disease Rating Scale (HY) 1 - 2 |
| Key exclusion criteria | Gastrointestinal diseases |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
