Phase
Condition
N/ATreatment
Assessment of severity of ICD (impulse control disorders)
Assessment of severity of Parkinson Disease
Blood analysis
Clinical Study ID
Ages 35-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient with PD according to the UKPDSBB criteria for at least 1 year beforerandomization
Patient, man or woman, aged from 35 to 75 years old
Patient with moderately severe ICD assessed by QUIP-RS (each item being rated 0-16)defined as:
a combined ICD total score (defined as the sum of the 4 ICD sub-scores (pathological gambling + buying + hypersexuality + eating)) superior or equalto 10 or,
at least one of the 4 ICD sub-scores in the following range:
"pathological gambling" sub-score from 6 to 12 (included),
"buying" sub-score from 8 to 12 (included),
"hypersexuality" sub-score from 8 to 12 (included),
"eating" sub-score from 7 to 12 (included) (Weintraub et al., 2012). Theuse of "lower" margins will guarantee that the patient experiencesbehavioral disturbances severe enough to justify pimavanserin treatment.On the other hand, the use of "upper" margins will guarantee that thepatients included in the trial will not suffer from ICD severe enough toquestion ethically the use of placebo during the 8 weeks of the treatment.Eligibility of patients with QUIP-RS sub-scores above 12 will be assessedupon investigator's request by an adjudication committee composed byindependent experts external to the study (cf IX.3 AdjudicationCommittee).
ICD onset after PD onset and after initiation of dopaminergic drugs
Patient treated by dopaminergic drugs for at least 3 months before randomization
Patient treated with a stable regimen of levodopa, dopamine agonists, COMT and MAOBinhibitors, amantadine, anticholinergic, antidepressant and benzodiazepine for atleast 1 month before the randomization and be willing to remain on the same dosesthroughout the course of their participation in the trial (Papay et al., 2014)
Patient with health insurance
Patient/ guardian / curator who sign the written informed consent
For women of childbearing potential, use of an effective contraception method* forat least 1 month prior to randomization until 8 weeks after the last dose of studydrug administration. Women who do not have an effective contraception* must : havehad her last natural menstruation ≥24 months prior to the selection visit, or havebeen surgically sterilized prior to the selection visit, or have had a hysterectomyprior to the selection visit.
Exclusion
Exclusion Criteria:
Patient suffering from another parkinsonian syndrome (multiple system atrophy,progressive supranuclear palsy, Lewy body dementia, corticobasal degeneration)
Patient who have a known hypersensitivity to the study treatment, based on knownallergies to drugs of the same class
Stroke, uncontrolled serious medical illness, myocardial infarction, congestiveheart failure, cardiac function disorders, within 6 months before randomization
Patient with history of long QT syndrome
Patient with long QTcB detected with ECG at inclusion visit (> 450 ms)
Patient treated with antipsychotic drugs during the last three months beforerandomization
Patient treated with concomitant medication leading to torsade de pointes (TdP)without discontinuation ≥ 5 half-lives before randomization (please refer tomedications list with known risks of TdP on appendix XVII.5.10 and check websitehttps://crediblemeds.org/index.php/tools/ for the most up-to-date information)
Patient with hydro-electrolytics troubles, particularly hypokaliemia or hypocalcemianot corrected, at inclusion visit or assessed no later than 8 days beforerandomization. To be eligible, the patient's electrolyte values should be within thefollowing limits:
3.5 ≤ K+ ≤ 5 mmol/L 135 ≤ Na+ ≤ 145 mmol/L 2,20 ≤ Ca2+ ≤ 2,60 mmol/L
Patient treated with a strong or moderate CYP3A4 inducer: carbamazepine, rifampicin,phenytoin, modafinil, efavirenz or a strong inhibitor of CYP3A4: azole antifungals,protease inhibitors, macrolids, without discontinuation ≥ 5 half-lives beforerandomization
Patient treated with medicinal plants interacting with CYP3A4 withoutdiscontinuation ≥ 5 half-lives before randomization (Echinacea (E.pupurea,E.angustifolia and E.pallida), Piperina, Artemisia, St. John's Wort and Ginkgo
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).
Patient suffering from severe depression or marked suicidal thoughts (score > 3 onthe suicidal thoughts item of the MADRS) at inclusion visit (Papay et al., 2014)
History of DBS within the past year before randomization, or change in stimulationparameters less than one month prior to randomization
Hematologic or solid malignancy diagnosis within 5 years prior to randomization.
[Note: Subjects with a history of localized skin cancer, basal cell or squamous cellcarcinoma, may be enrolled in the study as long as they are cancer free prior torandomization. Subjects with other localized cancers (without metastatic spread) whohave previously completed their course of treatment more than 5 years prior torandomization, are not currently receiving treatment and have been in remission maybe enrolled only if, in the opinion of the Investigator, there is no expectation forrecurrence or further cancer treatment during the study period. Antihormonal therapy (e.g., tamoxifen) is allowed if the subject's cancer is in remission and the subjectis on stable maintenance therapy to reduce their risk of recurrence.]
Patient suffering from severe renal impairment define as CrCL<30 mL/min,Cockcroft-Gault at inclusion visit or assessed no later than 8 days beforerandomization
Clinically significant hepatic impairment
Concurrent participation in another research involving a drug or medical device
Patient with language barriers precluding adequate understanding or co-operation orwho, in the opinion of the investigator, should not participate in the trial
Treatment with an investigational treatment within 30 days prior to randomization
Woman pregnant, nursing or of childbearing potential age without effectivecontraception methods* or intends to become pregnant.
- an effective contraception method is defined as implants, oraloestro-progestative contraceptives or progestative which inhibit ovulationcontraceptives (e.g, desogestrel), or double barrier method (condom plusspermicide or diaphragm plus spermicide) or levonorgestrel intrauterinedevices, or vasectomized partner (confirmed with two negative spermograms).
Study Design
Connect with a study center
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson CHU d'Amien, Hopital Sud
Amiens, 80054
FranceSite Not Available
Service de Neurologie -CHU Besançon
Besançon,
FranceActive - Recruiting
Service de Neurologie and CIC -CHU Besançon
Besançon,
FranceSite Not Available
SERVICE DE NEUROLOGIE C, Unité mouvement anormaux/Centre expert Parkinson, CHU de Lyon, Hopital neurologique Pierre Wertheimer
Bron, 69677
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson CHU Clermont-Ferrand, Hopital Gabriel Montpied
Clermont-Ferrand, 63003
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, Hopital Henri Mondor
Créteil, 94010
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Grenoble Alpes
Grenoble, 38043
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, CHU de Lille, Hopital Roger Salengro
Lille, 59037
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Limoges
Limoges, 87042
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, Hopital de la Timone
Marseille, 13385
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Nantes, Hopital Laennec
Nantes, 44093
FranceSite Not Available
SERVICE DE NEUROLOGIE Centre Expert Parkinson Hopital de la Pitié-Salpêtrière
Paris, 75651
FranceSite Not Available
Centre d'Inverstigation Clinique, CHU de Poitiers
Poitiers, 86021
FranceSite Not Available
SERVICE DE NEUROLOGIE, CHU de REIMS
Reims, 51100
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rennes, Hopital Pontchaillou
Rennes, 35033
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rouen, Hopital Charles Nicolle
Rouen, 76031
FranceSite Not Available
SERVICE DE NEUROLOGIE Unité de Mouvements Anormaux/Centre expert Parkinson, CHU de Strasbourg, Hopital de Hautepierre
Strasbourg, 67098
FranceSite Not Available
SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Toulouse, Hopital Pierre-Paul Riquet
Toulouse, 31059
FranceSite Not Available
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