Parkinson’s Disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: CX-8998
Pharmaceutical Form: Capsule
INN or Proposed INN: Suvecaltamide
CAS Number: 2249709-38-2
Current Sponsor code: JZP385
Other descriptive name: JZP385
Concentration unit: mg millig
Sponsors
Cavion, Inc., a subsidiary of Jazz Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female participants ages 40 to 85 years inclusive, at time of signing the ICF. Body mass index from 17 to 45 kg/m2 (inclusive) at Screening. Diagnosis of clinically probable or clinically established idiopathic PD meeting the MDS 2015 criteria within the past 5 years. Participants must be individually optimized on PD medications for the treatment of other cardinal signs of PD (bradykinesia, rigidity) per the judgement of the investigator. Optimized treatment is defined as the maximum therapeutic effect obtained with PD medications when no further improvement is expected regardless of any additional adjustments to these medications or when the PD medications or adjustments to these medications are anticipated to result in intolerable side effects. This will be based on the investigator’s clinical judgement Participants must be on a stable dosing regimen of their permitted PD and/or other tremor medications for the treatment of motor symptoms for at least 6 weeks prior to Screening and do not anticipate the need to make any changes for the duration of the study. A lack of use of medications used to treat motor symptoms also must be stable for 6 weeks prior to Screening and remain stable for the duration of the study For participants who experience motor fluctuations, tremor must also be present during “ON” periods and participants should be able to have tremor symptoms evaluated during “ON” periods, as determined by the investigator, in relation to the participant’s PD medications. If necessary, participants may take their PD medications in the clinic during visits where tremor symptoms are evaluated Participants have moderate to severe impairment associated with tremor at both the Screening and Baseline Visits Contraception: Male participants: Male participants are eligible to participate if they agree with study contraception during the study intervention period and for at least 30 days after the last dose of study intervention Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and following 1 of the contraception conditions Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Willing and able to comply with the study design schedule and other requirements 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Female participants who are pregnant, nursing, or lactating or plan to become pregnant during the study or within 90 days of study completion Known history or current evidence of other medical or neurological conditions that may cause or explain the participant’s tremor in the opinion of the investigator Hoehn & Yahr stage 5 Participants who only experience tremor during their “OFF” periods Severity of motor fluctuations or medication-induced dyskinesia that would interfere with the assessment of tremor and/or “ON”/“OFF” periods that are unpredictable per the opinion of the investigator Clinically significant symptomatic orthostatic hypotension Has evidence at Screening of cognitive impairment that would prevent completion of study procedures or the ability to provide informed consent Received any study intervention in a previous suvecaltamide clinical study History or presence of a clinically significant acute or unstable medical condition, chronic infection, malignancy other than basal cell carcinoma or resected noninvasive cutaneous squamous cell carcinoma, or surgical history that could affect the safety of the participant or interfere with study efficacy, safety, or PK assessments; or the ability of the participant to complete the study History or presence of gastrointestinal disease which is likely to significantly interfere with the absorption, metabolism, or elimination of suvecaltamide. History or presence of hepatic or renal disease, or any other condition that may interfere with absorption, distribution, metabolism, or excretion of drugs Presence of significant cardiovascular disease at Screening History or presence of bipolar and related mood disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders Current suicidal risk as determined from history, by presence of active suicidal ideation, or any history of suicide attempt; current or past major depressive episode. Participants with stable treated depression are allowed; the participant’s antidepressant treatment must be stable for at least 6 months prior to Screening and expected to remain stable for the duration of the study History or presence of substance use disorder, known drug dependence, or seeking treatment for alcohol or substance abuse related disorder. Nicotine use disorder would not be exclusionary if it does not impact tremor Treatment-naïve patients are excluded from participating in the study PRN use of medication/substance(s) that might interfere with the evaluation of tremor on study visit days, such as, but not limited to, stimulant decongestants, beta-agonist bronchodilators, benzodiazepine, sedative/hypnotics, and alcohol. Participants who consume caffeine or use tobacco should take their regular amount of caffeine or tobacco on the clinic days Prior or planned surgical intervention to treat PD PRN use of PD medications or other anti-tremor medications or continuous infusion of PD medication Inability to refrain from using a mechanical device for the management of tremor during the study Botulinum toxin injection in the 6 months before Screening or planned use at any time during the study Currently taking dopamine antagonists or depleting medications Use of prescription or nonprescription drugs or other products known to be inducers of CYP3A4, which cannot be discontinued at least 4 weeks before Baseline, or planned use at any time during the study Use of prescription or nonprescription drugs or other products known t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional and performance-based impairment due to tremor. ;Secondary Objective: To evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional impairment due to tremor.;Primary end point(s): Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional and performance-based impairment due to tremor;Timepoint(s) of evaluation of this end point: Change from Baseline to Week 17 on the TETRAS composite outcome score | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional impairment due to tremor safety: Incidence and severity of AEs as well as evaluation of safety laboratory assessments, vital signs, ECG results, C-SSRS and QUIP-RS. ;Timepoint(s) of evaluation of this end point: Time point is throughout the study. AE evaluation specifically begins after first dose. | — |
Countries
Germany, Poland, Spain, United States
Contacts
Public ContactMedical Monitor for JZP385-202
Jazz Pharmaceuticals, Inc.
Outcome results
None listed