Parkinson's DiseasePhase 2NCT00940914
Dopaminergic Loss and Pain in Parkinson's Disease
A Phase 2 study testing ioflupane 123I (DATSCAN®) in people with Parkinson's Disease and Pain, run by University Hospital, Toulouse at 1 site in France.
Trial summary
About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Parkinson's Disease, Pain
- What is being tested?
- ioflupane 123I (DATSCAN®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992).
- Male or Female patients, aged from 30 to 70 years.
- Patients must benefit from the French Social security system.
- Patients must give a written informed consent.
- Female fertile patients must use an efficient method of contraception.
- If patients suffer from chronic pain, pain must be related to Parkinson's disease.
Who cannot join
- Patients with a syndrome other than the idiopathic Parkinson's disease.
- Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed.
- Patients suffering from another disease causing chronic pain.
- Patients suffering from cancer.
- Patients with cognitive dysfunction.
- Patients not able to complete the scales.
- Pregnant, breastfeeding or fertile female patients not using an efficient method of contraception.
- Patients not willing to participle in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain
About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.
Read the detailed description
Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap, cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss.
The clinical trial will be conducted in a single center (Neurology Department, Purpan Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty patients with Parkinson's disease, presenting pain disorders or not, will be selected. This clinical trial will last one year. All the exams, including image acquisition will be done the same day. These will take about 6 hours for each patient.
Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate with pain intensity and also with thermal pain thresholds in patients suffering from Parkinson's disease.
- Conditions
- Parkinson's Disease, Pain
- Being tested
- ioflupane 123I (DATSCAN®)
- Keywords
- Parkinson's disease, pain, dopamine transporters imaging
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ioflupane 123I (DATSCAN®)Drug
Also called - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane, - FP-CIT
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
| Study group | Role | What they receive |
|---|---|---|
| pain disorders | Other | patients with Parkinson's disease presenting pain disorders Receives: Drug: ioflupane 123I (DATSCAN®) |
| without pain disorders | Other | patients with Parkinson's disease without pain disorders Receives: Drug: ioflupane 123I (DATSCAN®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters.
Measured: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Pain perception will be evaluated by the determination of subjective pain thresholds (thermal pain thresholds, thermotest). A thermode will be used to determine the heat and cold pain thresholds.
Measured: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Secondary outcomes (6)
Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale
Measured: Evaluation will be done within three hours before image acquisition (SPECT).
Short French version of McGill pain questionnaire (MPQ).
Measured: Evaluation will be done within three hours before image acquisition (SPECT).
Pain intensity will be assessed using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain).
Measured: Evaluation will be done within three hours before image acquisition (SPECT).
DN4 scale
Measured: Evaluation will be done within three hours before image acquisition (SPECT).
Brief Inventory Pain
Measured: Evaluation will be done within three hours before image acquisition (SPECT).
Hospital Anxiety and Depression (HAD) scale
Measured: Evaluation will be done within three hours before image acquisition (SPECT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Brefel-Courbon, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940914
- Sponsor's protocol ID
- 0730302
- Other IDs
- AOL 2007
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2009
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Dellapina E, Pellaprat J, Adel D, Llido J, Harroch E, Martini JB, Kas A, Salabert AS, Ory-Magne F, Payoux P, Brefel-Courbon C. Dopaminergic denervation using [123I]-FPCIT and pain in Parkinson's disease: a correlation study. J Neural Transm (Vienna). 2019 Mar;126(3):279-287. doi: 10.1007/s00702-019-01974-5. Epub 2019 Jan 31.
PubMed 30706197
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain
- ClinicalTrials.gov ID
- NCT00940914
- Acronym / sponsor ID
- 0730302
- Conditions
- Parkinson's Disease, Pain
- Keywords
- Parkinson's disease, pain, dopamine transporters imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.
Detailed description
Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap, cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss.
The clinical trial will be conducted in a single center (Neurology Department, Purpan Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty patients with Parkinson's disease, presenting pain disorders or not, will be selected. This clinical trial will last one year. All the exams, including image acquisition will be done the same day. These will take about 6 hours for each patient.
Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate with pain intensity and also with thermal pain thresholds in patients suffering from Parkinson's disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain disorders | Other | Drug: ioflupane 123I (DATSCAN®)patients with Parkinson's disease presenting pain disorders |
| without pain disorders | Other | Drug: ioflupane 123I (DATSCAN®)patients with Parkinson's disease without pain disorders |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992).
- Male or Female patients, aged from 30 to 70 years.
- Patients must benefit from the French Social security system.
- Patients must give a written informed consent.
- Female fertile patients must use an efficient method of contraception.
Key exclusion criteria (8 listed)
- Patients with a syndrome other than the idiopathic Parkinson's disease.
- Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed.
- Patients suffering from another disease causing chronic pain.
- Patients suffering from cancer.
- Patients with cognitive dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ioflupane 123I (DATSCAN®)Also: - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane, - FP-CITOne administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein) | Drug | pain disorders, without pain disorders |
Primary outcome
Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters.
Time frame: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
Pain perception will be evaluated by the determination of subjective pain thresholds (thermal pain thresholds, thermotest). A thermode will be used to determine the heat and cold pain thresholds.
Time frame: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.
6 secondary outcomes
Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale
Time frame: Evaluation will be done within three hours before image acquisition (SPECT).
Short French version of McGill pain questionnaire (MPQ).
Time frame: Evaluation will be done within three hours before image acquisition (SPECT).
Pain intensity will be assessed using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain).
Time frame: Evaluation will be done within three hours before image acquisition (SPECT).
DN4 scale
Time frame: Evaluation will be done within three hours before image acquisition (SPECT).
Brief Inventory Pain
Time frame: Evaluation will be done within three hours before image acquisition (SPECT).
Hospital Anxiety and Depression (HAD) scale
Time frame: Evaluation will be done within three hours before image acquisition (SPECT).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Results publication: PubMed 30706197Dellapina E, Pellaprat J, Adel D, Llido J, Harroch E, Martini JB, Kas A, Salabert AS, Ory-Magne F, Payoux P, Brefel-Courbon C. Dopaminergic denervation using [123I]-FPCIT and pain in Parkinson's disease: a correlation study. J Neural Transm (Vienna). 2019 Mar;126(3):279-287. doi: 10.1007/s00702-019-01974-5. Epub 2019 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Brefel-Courbon, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ioflupane 123I (DATSCAN®) in people with Parkinson's Disease and Pain, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters. (time frame: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.