Parkinson's DiseasePhase 3DOULOXNCT01504178
Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease
A Phase 3 study testing duloxetine, injection of apomorphine and L-Dopa in people with Parkinson's Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- duloxetine, injection of apomorphine and L-Dopa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2015
- Phase
- Phase 3
- 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 clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
- Parkinson's disease patients with a score ≤ 3 on the Hoehn and Yahr scale
- Patients treated with dopaminergic antiparkinsonian drugs (L-Dopa, dopamine agonists, ICOMT…)
- Patients affiliated to a social protection program
- Women with efficacy contraception
Who cannot join
- Patients suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies…)
- Parkinson's disease patients with a score > 3 on the Hoehn and Yahr scale
- Depressed patients (MADRS score < 16)
- Patients suffering from a cancer
- Patients under tutelage, curatella or law protection
- Patients with a complete contraindication against apomorphine injections or duloxetine administration (selective serotonin reuptake inhibitor and monoamine oxydase inhibitors)
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- Patients without any control of their arterial hypertension
- Patients with a neuroleptic treatment
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be involved in pain alteration in PD.
To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with PD.
36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. This increase would be the same than those observed with L-Dopa.
- Conditions
- Parkinson's Disease
- Being tested
- duloxetine, placebo of duloxetine, injection of apomorphine, injection of placebo of apomorphine, L-Dopa
- Keywords
- Noradrenergic system and pain in Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
administration during 28 days
placebo of duloxetineDrug
administration during 28 days
injection of apomorphineDrug
injection performed at D28
injection of placebo of apomorphineDrug
performed at D28
L-DopaDrug
Also called injection of L-dopa
performed at D28
injection of placebo of L-DopaDrug
performed at D28
| Study group | Role | What they receive |
|---|---|---|
| duloxetine | Experimental | The first group (12 patients) will receive, after 28 days of duloxetine treatment, one duloxetine dose, an injection of apomorphine and a placebo of L-Dopa. Receives: Drug: duloxetine; Drug: injection of apomorphine; Drug: injection of placebo of L-Dopa |
| positive control (L-Dopa) | Placebo comparator | The second group (12 patients) will receive, after 28 days of placebo treatment, one placebo dose of duloxetine, an injection of apomorphine and injection of placebo of L-Dopa. Receives: Drug: placebo of duloxetine; Drug: injection of apomorphine; Drug: injection of placebo of L-Dopa |
| negative control | Placebo comparator | The third group will receive, after 28 days of placebo treatment, one placebo of duloxetine, an injection of placebo of apomorphine and a dose of L-Dopa. Receives: Drug: placebo of duloxetine; Drug: injection of placebo of apomorphine; Drug: L-Dopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain threshold determined using thermal stimulations (thermotest) with the method of levels
Before duloxetine intake and after one month of chronic duloxetine intake
Measured: One month
Secondary outcomes (2)
Objective pain threshold determined recording the nociceptive reflex of flexion
Before duloxetine intake and after one month of chronic duloxetine intake
Measured: One month
Clinical evaluation of the severity of the motor handicap of patients using the Unified Parkinson's Disease Rating Scale (UPDRS III)
Before duloxetine intake and after one month of chronic duloxetine intake
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- French Parkinson Association
- Responsible party
- Sponsor
- Investigators
- Christine Brefel-Courbon, MD, Principal investigator, Purpan hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504178
- Sponsor's protocol ID
- 09 303 03
- Acronym
- DOULOX
- Status last verified
- Feb 2017
- First submitted
- 30 Dec 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01504178
- Acronym / sponsor ID
- DOULOX / 09 303 03
- Conditions
- Parkinson's Disease
- Keywords
- Noradrenergic system and pain in Parkinson's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- French Parkinson Association
- Study start
- May 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jan 2012 (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.
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be involved in pain alteration in PD.
To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with PD.
36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. This increase would be the same than those observed with L-Dopa.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| duloxetine | Experimental | Drug: duloxetine, Drug: injection of apomorphine, Drug: injection of placebo of L-DopaThe first group (12 patients) will receive, after 28 days of duloxetine treatment, one duloxetine dose, an injection of apomorphine and a placebo of L-Dopa. |
| positive control (L-Dopa) | Placebo comparator | Drug: placebo of duloxetine, Drug: injection of apomorphine, Drug: injection of placebo of L-DopaThe second group (12 patients) will receive, after 28 days of placebo treatment, one placebo dose of duloxetine, an injection of apomorphine and injection of placebo of L-Dopa. |
| negative control | Placebo comparator | Drug: placebo of duloxetine, Drug: injection of placebo of apomorphine, Drug: L-DopaThe third group will receive, after 28 days of placebo treatment, one placebo of duloxetine, an injection of placebo of apomorphine and a dose of L-Dopa. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
- Parkinson's disease patients with a score ≤ 3 on the Hoehn and Yahr scale
- Patients treated with dopaminergic antiparkinsonian drugs (L-Dopa, dopamine agonists, ICOMT…)
- Patients affiliated to a social protection program
- Women with efficacy contraception
Key exclusion criteria (9 listed)
- Patients suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies…)
- Parkinson's disease patients with a score > 3 on the Hoehn and Yahr scale
- Depressed patients (MADRS score < 16)
- Patients suffering from a cancer
- Patients under tutelage, curatella or law protection
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 |
|---|---|---|
| duloxetineadministration during 28 days | Drug | duloxetine |
| placebo of duloxetineadministration during 28 days | Drug | negative control, positive control (L-Dopa) |
| injection of apomorphineinjection performed at D28 | Drug | duloxetine, positive control (L-Dopa) |
| injection of placebo of apomorphineperformed at D28 | Drug | negative control |
| L-DopaAlso: injection of L-dopaperformed at D28 | Drug | negative control |
| injection of placebo of L-Dopaperformed at D28 | Drug | duloxetine, positive control (L-Dopa) |
Primary outcome
Subjective pain threshold determined using thermal stimulations (thermotest) with the method of levels
Time frame: One month
Before duloxetine intake and after one month of chronic duloxetine intake
2 secondary outcomes
Objective pain threshold determined recording the nociceptive reflex of flexion
Time frame: One month
Clinical evaluation of the severity of the motor handicap of patients using the Unified Parkinson's Disease Rating Scale (UPDRS III)
Time frame: One month
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 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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
Purpan 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 3 study testing duloxetine, injection of apomorphine and L-Dopa in people with Parkinson's Disease, 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 5 inclusion and 9 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 23 Feb 2017. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Subjective pain threshold determined using thermal stimulations (thermotest) with the method of levels (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.