Parkinson DiseasePhase 2NCT05642442
A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
A Phase 2 study testing Suvecaltamide in people with Parkinson Disease and Tremor, run by Jazz Pharmaceuticals at 37 sites in 4 countries.
Trial summary
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Tremor
- What is being tested?
- Suvecaltamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 37 sitesin 4 countries
- Study dates
- 1 Dec 2022to 11 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- A score of > 21 on the TETRAS-ADL subscale; and
- CGI-S rating of tremor severity of > 2 (at least moderate for participants ability to function).
Who cannot join
- 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, including, but not limited to: psychogenic tremor; myoclonus or ataxia; cerebellar disease; traumatic brain injury; alcohol abuse or withdrawal; mercury poisoning; hyperthyroidism; pheochromocytoma; multiple sclerosis; clinically significant polyneuropathy in the opinion of the investigator; or family history or diagnosis of Fragile X syndrome. 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.
Show all 24Show fewer
- 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 for the treatment of tremor 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 locations and contacts
37 sites in 4 countries.
37 sites in 4 countries
United States21 sites
Albany Medical College
Albany, New York, 12208
The Nene and Jamie Koch Comprehensive Movement Disorders Center
Albuquerque, New Mexico, 87106
Neurology of Central Florida Research Center LLC
Altamonte Springs, Florida, 32714
Dent Neurologic Institute
Amherst, New York, 14226
NeuroTrials Research Inc.
Atlanta, Georgia, 30328
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, 80045
Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, 33486
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, 60611
University of Cincinnati Gardner Neuroscience Institute (UCGNI)
Cincinnati, Ohio, 45219
Hawaii Pacific Health
Honolulu, Hawaii, 96817
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
University of Kansas Medical Center
Kansas City, Kansas, 66160
EverGreenHealth Neuroscience Institute
Kirkland, Washington, 98034
University of Kentucky, College of Medicine, Department of Neurology
Lexington, Kentucky, 40536
Keck School of Medicine of University of Southern California (USC)
Los Angeles, California, 90033
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Irving Medical Center
New York, New York, 10032
South Shore Neurologic Associates PC
Patchogue, New York, 11772
Central Texas Neurology Consultants
Round Rock, Texas, 78681
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613
Poland6 sites
Neurologia Slaska Centrum Medyczne
Katowice, 40-689
Centrum Medyczne Plejady
Krakow, 30-363
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M.i M. Nastaj Spólka Partnerska
Lublin, 20-064
Maxxmed Centrum Zdrowia i Urody w Lublinie
Lublin, 20-080
Gabinety Lekarskie Rivermed Sp. z o.o.
Poznan, 61-441
ETG Neuroscience Sp. z o.o.
Warsaw, 02-777
Germany5 sites
Zentrum f. klinische Forschung Dr. I. Schöll
Bad Homburg, 61350
Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, 091111
Curiositas-ad-sanum Beratungs-und Studien GmbH
Haag in Oberbayern, 83527
Deutsche Klinik fur Diagnostik Helios Klinik Wiesbaden
Hessen, 65191
Velocity Clinical Research Germany GmbH, Location Wiesbaden
Wiesbaden, 65189
Spain5 sites
Hospital Universitario Cruces
Barakaldo, 48903
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Ramón y Cajal
Madrid, 28034
Hospital Universitario Virgen Macarena
Seville, 41009
About this study
Official title: A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants With Parkinson's Disease
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). The target population represents participants who have tremor that is not adequately controlled by PD medications and that interferes with their activities of daily living (ADL) and/or with their performance of tasks.
Read the detailed description
Participants will be randomized 1:1 to receive suvecaltamide or placebo and stratified by the Essential Tremor Rating Scale (TETRAS) composite outcome score (≤ 17 or > 17) as assessed at baseline. The maximum total duration of the study for each participant will be 23 weeks, with a maximum treatment duration of 17 weeks. For each participant, the study consists of a Screening Period (up to 4 weeks), a 5-week Dose Titration and Optimization Period, a 12-week Maintenance Period, and a 2-week Safety Follow-up Period.
- Conditions
- Parkinson Disease, Tremor
- Being tested
- Placebo, Suvecaltamide
- Keywords
- Suvecaltamide, Moderate tremor, Severe tremor, Parkinson's disease, JZP385, Residual tremor, T-type calcium channels, Movement disorders, Tremor, Parkinson's disease tremor
- Medical subject headings
- Parkinson Disease, Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo capsule(s) administered every day (QD) orally. Titration may proceed at a rate of 1 matching placebo capsule per day every 7 days as required for optimal efficacy and tolerability up to a maximum number of 3 matching placebo capsules per day.
SuvecaltamideDrug
Also called JZP385, CX-8998, MK-8998
Suvecaltamide capsule administered every day (QD) orally. Titration may proceed at a rate of 10 mg suvecaltamide per day every 7 days as required for optimal efficacy and tolerability up to a maximum dose of 30 mg suvecaltamide per day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period. Receives: Drug: Placebo |
| Sulvecaltamide | Experimental | Participants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period. Receives: Drug: Suvecaltamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score
The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6a, 6b, and 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6a, 6b, and 7 of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe tremor. The change from baseline is being reported where the greater the change from baseline indicates improvement in outcome.
Measured: Baseline to Week 17
Secondary outcomes (8)
Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)
The CGI-S is a 5-point Likert-type rating scale assessed by qualified personnel to assess the severity of the impact of tremor in PD on the participants' ability to function. The responses to this investigator-completed scale range from 1 (no limitations) to 5 (severe), with higher scores indicating a worse outcome.
Measured: Baseline to Week 17
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)
The TETRAS-ADL subscale is a patient-rated scale of the impact of tremor on day-to-day functioning administered by a trained interviewer. This subscale directly measures how a patient functions by assessing activities impacted by tremor, such as eating and drinking, dressing and personal hygiene, carrying items, and fine motor skills. The TETRAS-ADL is the sum of 12 items and are rated on a 0 (normal) to 4 (severe) scale. The maximum total score is 48. Higher scores represent more severe tremor. The change from baseline is reported where the greater the change from baseline indicates improvement in outcome.
Measured: Baseline to Week 17
Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)
The PGI-S is a 5-point Likert-type rating scale, with response options ranging from 1 (no limitations) to 5 (severe), with higher scores indicating a worse outcome. The participant will rate his/her impression of the severity of the impact of their tremor in PD on their current ability to function.
Measured: Baseline to Week 17
Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17
The PGI-C is a 5-point Likert-type rating scale that participants use to rate the change in severity of their ability to function due to tremor since baseline. The responses to this scale range from 1 (Much improved) to 5 (Much worse), with higher scores indicating a worse outcome.
Measured: Baseline to Week 17
Percentage of Participants Who Were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17
The CGI-C is a 5-point Likert-type rating scale that a qualified medical personnel will use to rate the change in severity of the participants' ability to function due to their tremor since baseline. The responses to this scale range from 1 (Much improved) to 5 (Much worse), with higher scores indicating a worse outcome.
Measured: Baseline to Week 17
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)
The TETRAS-PS is a clinical rating scale performed by a blinded rater that quantifies tremor in the head, face, voice, limbs, and trunk. Each item will be rated on a scale of 0 (normal) to 4 (severe). The sum of the individual scores provides the overall score, ranging from 0 to 64, with higher scores representing more severe tremor. The change from baseline is being reported with the greater change indicating improvement in outcome.
Measured: Baseline to Week 17
Change From Baseline to Week 17 on TETRAS Total Score (TETRAS-ADL + TETRAS-PS)
The TETRAS total score is the sum of the scores of the full TETRAS-ADL and TETRAS-PS subscales. Each item is rated on a 0 (normal) to 4 (severe) scale, and total scores range from 0 to 112, with higher scores representing more severe tremor. The TETRAS-PS is performed by a blinded rater. The change from baseline is being reported with the greater change indicating an improvement in clinical outcome.
Measured: Baseline to Week 17
Change From Baseline to Week 17 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Tremor Score
The MDS-UPDRS tremor score is the sum of selected items from MDS-UPDRS questionnaire Part II (Item 2.10) and 10 items from Part III (Items 3.15a,b, 3.16a,b, 3.17a-e, and 3.18). Item 2.10 assesses the patient report of the presence of tremor and impact on daily activities. Items 3.15, 3.16, and 3.17 are clinician assessments of the amplitude of distinct types of tremor (resting, postural, and kinetic respectively)in the right and left upper extremities separately. Item 3.17 also includes separate clinician assessments for both lower extremities and for the lip/jaw. Item 3.18 provides a clinician assessment of the constancy of rest tremor without regard to anatomical location. The rating for each item ranges from 0 (normal) to 4 (severe) with a maximum possible total MDS-UPDRS tremor score of 44. Higher scores indicate more severe clinical outcome. The change from baseline is being reported with the greater change indicating an improvement in clinical outcome.
Measured: Baseline to Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022
- Primary completion23 Oct 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jazz Study Director, Study director, Jazz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642442
- Sponsor's protocol ID
- JZP385-202
- Other IDs
- 2022-001063-27, 2024-515177-94-00
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2022
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05642442
- Acronym / sponsor ID
- JZP385-202
- Conditions
- Parkinson Disease, Tremor
- Keywords
- Suvecaltamide, Moderate tremor, Severe tremor, Parkinson's disease, JZP385, Residual tremor, T-type calcium channels, Movement disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Posted 15 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). The target population represents participants who have tremor that is not adequately controlled by PD medications and that interferes with their activities of daily living (ADL) and/or with their performance of tasks.
Detailed description
Participants will be randomized 1:1 to receive suvecaltamide or placebo and stratified by the Essential Tremor Rating Scale (TETRAS) composite outcome score (≤ 17 or > 17) as assessed at baseline. The maximum total duration of the study for each participant will be 23 weeks, with a maximum treatment duration of 17 weeks. For each participant, the study consists of a Screening Period (up to 4 weeks), a 5-week Dose Titration and Optimization Period, a 12-week Maintenance Period, and a 2-week Safety Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period. |
| Sulvecaltamide | Experimental | Drug: SuvecaltamideParticipants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (24 listed)
- 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, including, but not limited to: psychogenic tremor; myoclonus or ataxia; cerebellar disease; traumatic brain injury; alcohol abuse or withdrawal; mercury poisoning; hyperthyroidism; pheochromocytoma; multiple sclerosis; clinically significant polyneuropathy in the opinion of the investigator; or family history or diagnosis of Fragile X syndrome. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching placebo capsule(s) administered every day (QD) orally. Titration may proceed at a rate of 1 matching placebo capsule per day every 7 days as required for optimal efficacy and tolerability up to a maximum number of 3 matching placebo capsules per day. | Drug | Placebo |
| SuvecaltamideAlso: JZP385, CX-8998, MK-8998Suvecaltamide capsule administered every day (QD) orally. Titration may proceed at a rate of 10 mg suvecaltamide per day every 7 days as required for optimal efficacy and tolerability up to a maximum dose of 30 mg suvecaltamide per day. | Drug | Sulvecaltamide |
Primary outcome
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score
Time frame: Baseline to Week 17
The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6a, 6b, and 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6a, 6b, and 7 of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe tremor. The change from baseline is being reported where the greater the change from baseline indicates improvement in outcome.
8 secondary outcomes
Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline to Week 17
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)
Time frame: Baseline to Week 17
Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)
Time frame: Baseline to Week 17
Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17
Time frame: Baseline to Week 17
Percentage of Participants Who Were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17
Time frame: Baseline to Week 17
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)
Time frame: Baseline to Week 17
Change From Baseline to Week 17 on TETRAS Total Score (TETRAS-ADL + TETRAS-PS)
Time frame: Baseline to Week 17
Change From Baseline to Week 17 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Tremor Score
Time frame: Baseline to Week 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jazz Study Director study director
Jazz Pharmaceuticals
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvecaltamide in people with Parkinson Disease and Tremor, run by Jazz Pharmaceuticals at 37 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Poland, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score (time frame: Baseline to Week 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.