A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
Launched by JAZZ PHARMACEUTICALS · Nov 30, 2022
Trial Information
Current as of January 16, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new medication called suvecaltamide to see if it can help reduce tremors in adults with Parkinson's disease who still experience significant shaking despite their current treatments. The study will last for 17 weeks and will involve comparing the effects of the medication to a placebo (a harmless pill with no active ingredients) to determine if it is safe and effective for managing these tremors.
To participate, individuals must be diagnosed with Parkinson's disease and have moderate to severe tremors that interfere with their daily activities. They should also be stable on their Parkinson's medications for at least six weeks before joining the study. Participants will receive either the study medication or a placebo without knowing which one they are taking. Throughout the trial, they will be monitored to evaluate changes in their tremor severity and overall function. This study is currently recruiting participants and aims to provide valuable insights into treating tremors associated with Parkinson’s disease.
Gender
ALL
Eligibility criteria
- KEY Inclusion Criteria:
- • Diagnosis of clinically probable or clinically established Parkinson's disease (PD) meeting the Movement Disorder Society (MDS) 2015 criteria.
- • Participants must be individually optimized on PD medications for the treatment of other cardinal signs of PD (bradykinesia, rigidity) per the judgment of the investigator.
- • Participants must be on a stable dosing regimen of their permitted PD and/or other tremor (eg, propranolol) 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.
- * Participants have moderate to severe impairment associated with tremor at both the screening and baseline visits, as determined by all the following:
- • 1. A score of \> 21 on The Essential Tremor Assessment Rating Scale, Activities of Daily Living (TETRAS-ADL) subscale; and
- • 2. Clinician Global Impression of Severity (CGI-S) rating of tremor severity of \> 2 (at least moderate for participant's ability to function).
- KEY Exclusion Criteria:
- • Medical Conditions
- • 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. Note: Participants with a history of essential tremor are eligible.
- • Hoehn \& Yahr stage 5 (confinement to bed or wheelchair unless aided).
- • 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 in the opinion of the investigator.
- • Has evidence at screening of cognitive impairment as defined by a Montreal Cognitive Assessment (MoCA) score \< 22 or has a cognitive impairment that, in the investigator's opinion, would prevent completion of study procedures or the ability to provide informed consent.
- • History or presence of gastrointestinal disease (including prior bariatric bypass surgery), hepatic (including ALT or AST ≥ 2 × ULN or total bilirubin ≥ 1.5 ULN), or severe renal impairment or end-stage renal disease, or any other condition that, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of suvecaltamide.
- • Presence of significant cardiovascular disease at Screening
- • History or presence of bipolar and related mood disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- • Prior/Concomitant Therapy
- • Treatment-naïve patients (ie, those who have never tried PD medication) are excluded from participating in the study.
- • Use of PRN medication/substance(s) that might produce or interfere with the evaluation of tremor on study visit days prior to discharge
- • Prior or planned surgical intervention to treat PD, including but not limited to magnetic resonance-guided focused ultrasound thalamotomy, deep brain stimulation, ablative thalamotomy, and gamma knife thalamotomy.
- • Use of PRN medications to treat tremor or continuous infusion of PD medications. Note: Use of dopaminergic rescue medications (eg, PRN use of carbidopa/levodopa, including levodopa inhalation powder) for non-tremor PD symptoms (eg, rigidity or bradykinesia) is permitted.
- • Botulinum toxin injection in the 6 months before screening or planned use at any time during the study. Note: Use of botulinum toxin for other reasons (eg, cosmetic, excessive salivation, dystonia) is permitted as long as the location of use is anatomically distinct from the region with tremor.
- • Use of prescription or nonprescription drugs or other products (eg, St. John's Wort) known to be inducers of cytochrome 3A4 (CYP3A4) (cause \> 30% reduction of sensitive substrates area under the plasma concentration-time curve \[AUC\]), 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 (eg, grapefruit) known to be strong or moderate inhibitors of CYP3A4, which cannot be discontinued 2 weeks or 5 half-lives, whichever is longer, before baseline, or planned use at any time during the study.
- • Use of proton pump inhibitors, which cannot be discontinued at least 2 weeks before baseline, or planned use at any time during the study. (Occasional use of antacids or histamine receptor type 2 \[H2\] receptor antagonists will be permitted, but antacids should be taken at least 4 hours apart from study intervention; H2 receptor antagonists should be taken at least 4 hours after and/or 12 hours before study intervention).
- • Diagnostic Assessments
- • Known use of recreational drugs, inclusive of the following: phencyclidine, cocaine, opioids, barbiturates, amphetamines, or 3,4-methylenedioxymethamphetamine \[ecstasy\].
- • Opioid use at stable doses, either regularly or PRN, for pain management, as prescribed, is permitted. Use of cannabinoids (including cannabidiol) is permitted if there is no impact on tremor symptoms per the judgment of the investigator.
- • Other protocol-defined inclusion and exclusion criteria may apply.
Trial Officials
Jazz Study Director
Study Director
Jazz Pharmaceuticals
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to identifying, developing, and commercializing innovative therapies that address unmet medical needs in various therapeutic areas, including sleep disorders, neurology, and hematology. With a strong commitment to advancing patient care, Jazz Pharmaceuticals leverages cutting-edge research and development to deliver transformative medicines that improve the quality of life for patients. The company emphasizes collaboration and integrity in its clinical trials, striving to ensure robust scientific rigor and ethical standards throughout its research endeavors. Through its innovative approaches and patient-centric focus, Jazz Pharmaceuticals aims to make a meaningful impact in the lives of those it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kansas City, Kansas, United States
Houston, Texas, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Cincinnati, Ohio, United States
Amherst, New York, United States
Madrid, , Spain
Madrid, , Spain
Ulm, , Germany
Sevilla, , Spain
Boca Raton, Florida, United States
Barcelona, , Spain
Round Rock, Texas, United States
New York, New York, United States
Jacksonville, Florida, United States
Honolulu, Hawaii, United States
Katowice, , Poland
Scottsdale, Arizona, United States
Aurora, Colorado, United States
Kraków, , Poland
Los Angeles, California, United States
Rogers, Arkansas, United States
Barakaldo, , Spain
Tampa, Florida, United States
Memphis, Tennessee, United States
Kirkland, Washington, United States
Chicago, Illinois, United States
Atlanta, Georgia, United States
Patchogue, New York, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Alexandria, Virginia, United States
Albuquerque, New Mexico, United States
Poznań, , Poland
Los Angeles, California, United States
Georgetown, Texas, United States
Fairfax, Virginia, United States
Kirkland, Washington, United States
Altamonte Springs, Florida, United States
Lublin, , Poland
Warszawa, , Poland
Honolulu, Hawaii, United States
Lexington, Kentucky, United States
Cincinnati, Ohio, United States
Hanover, Lower Saxony, Germany
Duesseldorf, Nordrhein Westfalen, Germany
Lublin, , Poland
Plewiska, , Poland
Bad Homburg, , Germany
Chemnitz, , Germany
Haag In Oberbayern, , Germany
Hessen, , Germany
Lublin, , Poland
San Sebastián, , Spain
Wiesbaden, , Germany
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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