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|NCT02906020 : A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation|
|Ages||Min: 18 Years Max: 70 Years|
Inclusion criteria :
- Male and female adults with a diagnosis of PD and who are heterozygous carriers of a
GBA mutation associated with PD.
- Patients carrying known sequence variants associated with GBA-PD (such as E326K) must
have rapid eye movement (REM) sleep behavior disorder (RBD) confirmed by historically
documented polysomnography or by questionnaire.
- Age ?18 years to 70 years inclusive at the time of informed consent signing.
- Have symptoms of PD ?2 years.
- Hoehn and Yahr (H and Y) stage of 2 or lower at baseline.
- Stable medication regimen of PD drugs for at least 30 days (at least 60 days for
rasagiline) prior to randomization.
- The patient is willing to abstain from grapefruit containing products for 72 hours
prior to administration of the first dose of GZ/SAR402671 and for duration of the
entire treatment period (Periods 2 and 3).
- Signed written consent.
- Parkinsonism due to drug(s) or toxin(s).
- Patients carrying mutations in genes other than GBA that have been associated with an
increased risk for PD, specifically LRKK2 (G2019S).
- Patients with Gaucher disease (GD), defined by the presence of 2 mutated GBA alleles.
- Montreal Cognitive Assessment score <20 at Screening Visit.
- Patients with prior surgical history of deep brain stimulation (DBS).
- Patients with baseline brain MRI without contrast showing a structural abnormality
that is a possible cause of their PD signs or symptoms.
- Hepatic insufficiency with liver function tests (LFT) >2 times upper limit of normal
at Screening Visit.
- The patient has prior known positive result on any of the following tests: hepatitis
B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibodies, anti-human
immunodeficiency virus 1 and 2 antibodies (anti-HIV 1 and anti-HIV 2 Ab). Patients
with a positive hepatitis B surface antibody (HBsAb) test with a history of prior
hepatitis B immunization are eligible if other criteria are met (ie, negative tests
for : HBsAg, hepatitis B core antibody [HBcAb],and hepatitis C [HCVAb].
- Renal insufficiency as defined by creatine >1.5 times normal at Screening Visit.
- The patient has received strong or moderate inducers or inhibitors of CYP3A4 within
30 days or 5 half-lives from screening, whichever is longer, prior to randomization.
- The patient has, according to World Health Organization (WHO) Grading, a cortical
cataract > one-quarter the lens circumference (grade cortical catact-2 [COR-2]) or a
posterior subcapsular cataract >2 mm (grade posterior subscapsular cataract [PSC-2]).
Patient with nuclear cataracts will not be excluded.
- The patient is currently receiving potentially cataractogenic medications, including
chronic regimen (more frequently than every 2 weeks) of any dose or route of
corticosteroids or any medication that can cause cataract, according to the
- If female, pregnancy (defined as positive beta-human chorionic gonadotrophin
[Beta-HCG] blood test) or lactating or breast-feeding.
- Any medical disorders that, in the opinion of the Investigator, could interfere with
study-related procedures. This includes condition(s) that preclude the safety
performance of routine lumbar punctures, such as prohibitive spinal diseases,
bleeding diasthesis, or clinically significant coagulopathy or thrombocytopenia.
- Current participation in another investigational interventional study.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02906020
| Link to official Clinicaltrials.gov listing