Study of pimavanserin efficacy for the treatment of impulse controldisorders in Parkinson's disease

Phase 1

• Conditions: Impulse control disorders (ICD) in Parkinson's disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001229-15-FR
• Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Patient with PD according to the UKPDSBB criteria for at least 1 year
before randomization
2. Patient, man or woman, aged from 35 to 75 years old
3. Patient with moderately severe ICD defined as:
• a combined ICD total score (defined as the sum of the 4 ICD subscores
(pathological gambling + buying + hypersexuality + eating)) ?
10 or,
• at least one of the 4 ICD sub-scores in the following range:
a. pathological gambling sub-score from 6 to 12 (included),
b. buying sub-score from 8 to 12 (included),
c. hypersexuality sub-score from 8 to 12 (included),
d. eating sub-score from 7 to 12 (included) (Weintraub et al., 2012).
The use of lower margins will guarantee that the patient experiences
behavioral disturbances severe enough to justify pimavanserin
treatment. On the other hand, the use of upper margins will guarantee
that the patients included in the trial will not suffer from ICD severe
enough to question ethically the use of placebo during the 8 weeks of
the treatment
4. ICD onset after PD onset and after initiation of dopaminergic drugs
5. Patient treated by dopaminergic drugs for at least 3 months before
randomization
6. Patient treated with a stable regimen of levodopa, dopamine
agonists, COMT and MAOB inhibitors, amantadine, anticholinergic,
antidepressant and benzodiazepine for at least 1 month before the
randomization and be willing to remain on the same doses throughout
the course of their participation in the trial (Papay et al., 2014)
7. Patient with health insurance
8. Patient/ guardian / curator who sign the written informed consent
9. For women of childbearing potential, use of an effective
contraception method* for at least 1 month prior to randomization until
8 weeks after the last dose of study drug administration. Women who do
not have an effective contraception* must : have had her last natural
menstruation =24 months prior to the selection visit, or have been
surgically sterilized prior to the selection visit, or have had a
hysterectomy prior to the selection visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Patient suffering from another parkinsonian syndrome (multiple
system atrophy, progressive supranuclear palsy, Lewy body dementia,
corticobasal degeneration)
2. Patient who have a known hypersensitivity to the study treatment,
based on known allergies to drugs of the same class
3. Stroke, uncontrolled serious medical illness, myocardial infarction,
congestive heart failure, cardiac function disorders, within 6 months
before randomization
4. Patient with history of long QT syndrome
5. Patient with long QTcB detected with ECG at inclusion visit (> 450
ms)
6. Patient treated with antipsychotic drugs during the last three months
before randomization
7. Patient treated with concomitant medication leading to torsade de
pointes (TdP) (please refer to medications list with known risks of TdP
on appendix XVII.5.10 and check website
https://crediblemeds.org/index.php/tools/ for the most up-to-date
information)
8. Patient with hydro-electrolytics troubles, particularly hypokaliemia
or hypocalcemia not corrected, at inclusion visit
9. Patient treated with a strong inhibitor of CYP3A4: azole antifungals,
protease inhibitors, macrolids without discontinuation = 5 half-lives
before randomization
10. Patient treated with medicinal plants interacting with CYP3A4
(Echinacea (E.pupurea, E.angustifolia and E.pallida), Piperina, Artemisia,
St. John's Wort et Ginkgo
11. Patient with Montreal Cognitive Assessment (MoCA) (Nasreddine et
al., 2005) score < 20 (to exclude patients likely with dementia) at
inclusion visit (Papay et al., 2014).
12. Patient suffering from severe depression or marked suicidal
thoughts (score > 3 on the suicidal thoughts item of the MADRS) at
inclusion visit (Papay et al., 2014)
13. History of DBS within the past year before randomization
14. Patient suffering from a cancer
15. Patient suffering from severe renal impairment define as CrCL <30
mL/min, Cockcroft-Gault at inclusion visit
16. Clinically significant hepatic impairment
17. Current participation in another research involving human beings of category 1 or 2
18. Patient with language barriers precluding adequate understanding
or co-operation or who, in the opinion of the investigator, should not
participate in the trial
19. Treatment with an investigational treatment within 30 days prior to
randomization
20. Woman pregnant, nursing or of childbearing potential age without
effective contraception methods or intends to become pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified