Pathophysiology of pain in Parkinson's disease: exploration of the serotonin system in positron emission tomography

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

10 Jun 2024 → ongoing

Decision date (initial)

2023-05-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Agence Nationale pour la Recherche

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The primary endpoint is the distribution volume ratio of [18F]-MPPF (DVR) using the cerebellum as the reference region, measured in both groups of painful and non-painful PD patients

Secondary objectives 3

1. assess the relationship between [18F]-MPPF uptake and :  central pain intensity, other central pain characteristics and pain-induced functional discomfort only in painful parkinsonian patients  pain perception thresholds in the 2 groups of patients;
2. compare the functional networks related to pain on resting-state functional MRI between the 2 groups of patients
3. evaluate, for the 2 groups of patients, the link between :  cerebral structural characteristics (cerebral macro/microstructural markers collected in MRI) and pain parameters (central pain intensity, and other pain characteristics, pain-induced functional discomfort and pain perception thresholds);  [18F]-MPPF uptake and pain-related functional networks in resting-state MRI.

Conditions and MedDRA coding

Parkinson's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients with Parkinson's disease defined according to UKPDSBB criteria
2. Men and women aged between 35 and 85 years
3. Patients with stable anti-parkinsonian treatment for at least 2 weeks prior to V2
4. Patients with a MOCA score ≥ 24
5. Patients with a HADS-D score ≤ 11
6. Person affiliated or benefiting from a social security scheme.
7. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria 9

1. Patients treated with second line therapy (deep brain stimulation, pump - duodopa and apokinon)
2. Patients with a history of significant psychiatric pathology according to the investigator
3. Patients treated with drugs interacting with 5HT1A receptors in the previous 2 weeks ( serotonergic antidepressants)
4. Patients with contraindication to MRI
5. Patients refusing to be informed of an abnormality discovered during brain imaging
6. Patients with dyskinesias judged by the investigator to be disabling for imaging
7. Patients under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
8. Pregnant woman, breastfeeding woman
9.  Triptans taken in the 48 hours preceding PET

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the distribution volume ratio of [18F]-MPPF (DVR) using the cerebellum as the reference region, measured in both groups of painful and non-painful PD patients

Secondary endpoints 3

1. assess the relationship between [18F]-MPPF uptake and :  central pain intensity, other central pain characteristics and pain-induced functional discomfort only in painful parkinsonian patients  pain perception thresholds in the 2 groups of patients
2. compare the functional networks related to pain on resting-state functional MRI between the 2 groups of patients;
3. evaluate, for the 2 groups of patients, the link between :  cerebral structural characteristics (cerebral macro/microstructural markers collected in MRI) and pain parameters (central pain intensity, and other pain characteristics, pain-induced functional discomfort and pain perception thresholds);  [18F]-MPPF uptake and pain-related functional networks in resting-state MRI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

Cedex 9, 2 Rue Viguerie 2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

clinical research assistant (sponsor)

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

clinical research assistant (sponsor)

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications