A Study of Suvecaltamide in Adults with Moderate to Severe Residual Tremor in Parkinson’s Disease

Phase 1

Conditions: Parkinson’s Disease
MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2022-001063-27-PL

Lead Sponsor: Cavion, Inc., a subsidiary of Jazz Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 160

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional and performance-based impairment due to tremor.<br><br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy:<br>Evaluate the efficacy of suvecaltamide administered once daily for 17 weeks to improve functional impairment due to tremor<br>safety:<br>Incidence and severity of AEs as well as evaluation of safety laboratory assessments, vital signs, ECG results, C- SSRS, QUIP-RS.;Timepoint(s) of evaluation of this end point: Time point is throughout the study. AE evaluation specifically begins after first dose.<br><br>

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