Effect of selective COX-2 inhibition on neuroinflammation in Parkinson's disease
| ISRCTN | ISRCTN59798735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59798735 |
| Secondary identifying numbers | 16901 |
- 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
| Study design | Open, non-randomised, non-placebo controlled, pilot phase trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Celecoxib |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
University/education
University/education
Hanzeplein 1
Groningen
9700 RB
Netherlands
| k.l.leenders@neuro.umcg.nl | |
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Hospital/treatment centre
University Medical Center Groningen (UMCG) Neurology department deparmental funding (The Netherlands)
No information available
Stichting International Parkinson Fonds (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
