Trial · NCT05642442

A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease

NCT05642442, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2026-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease. Trials, record NCT05642442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05642442

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
NCT number: NCT05642442
Status: Completed
Phases: Phase 2
Enrollment: 169 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Parkinson Disease, Tremor
Interventions: Placebo, Suvecaltamide
First posted: 2022-12-08
Last updated: 2026-01-15
Other registries' IDs: eudract:2022-001063-27
Results first posted: 2026-01-15

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score	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.
Secondary	Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)	Baseline to Week 17	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.
Secondary	Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)	Baseline to Week 17	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.
Secondary	Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)	Baseline to Week 17	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.
Secondary	Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17	Baseline to 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.
Secondary	Percentage of Participants Who Were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17	Baseline to 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.
Secondary	Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)	Baseline to Week 17	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.
Secondary	Change From Baseline to Week 17 on TETRAS Total Score (TETRAS-ADL + TETRAS-PS)	Baseline to Week 17	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.
Secondary	Change From Baseline to Week 17 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Tremor Score	Baseline to Week 17	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score	Baseline to Week 17	Mean TETRAS composite outcome score was assessed in participants with available data in the Full Analysis Set.	score on a scale	MEAN
SECONDARY	Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)	Baseline to Week 17	CGI-S was assessed in participants with available data in the Full Analysis Set.	percentage of participants	NUMBER
SECONDARY	Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)	Baseline to Week 17	TETRAS-ADL was assessed in participants with available data in the Full Analysis Set.	score on scale	MEAN
SECONDARY	Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)	Baseline to Week 17	PGI-S was assessed in participants with available data in the Full Analysis Set.	percentage of patients	NUMBER
SECONDARY	Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17	Baseline to Week 17	PGI-C was assessed in participants with available data in the Full Analysis Set.	percentage of patients	NUMBER
SECONDARY	Percentage of Participants Who Were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17	Baseline to Week 17	CGI-C was assessed in participants with available data in the Full Analysis Set.	percentage of patients	NUMBER
SECONDARY	Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)	Baseline to Week 17	TETRAS-PS was assessed in participants with available data in the Full Analysis Set.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 17 on TETRAS Total Score (TETRAS-ADL + TETRAS-PS)	Baseline to Week 17	TETRAS total score was assessed in participants with available data in the Full Analysis Set.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 17 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Tremor Score	Baseline to Week 17	MDS-UPDRS was assessed in participants with available data in the Full Analysis Set.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score	Sulvecaltamide	-6.4	Standard Deviation 5.39	score on a scale
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score	Placebo	-5.3	Standard Deviation 5.73	score on a scale
Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)	Sulvecaltamide	54.6		percentage of participants
Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)	Placebo	40.1		percentage of participants
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)	Sulvecaltamide	-7.5	Standard Deviation 7.04	score on scale
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)	Placebo	-5.8	Standard Deviation 6.48	score on scale
Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)	Sulvecaltamide	54.0		percentage of patients
Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)	Placebo	43.7		percentage of patients
Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17	Sulvecaltamide	23.9		percentage of patients
Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17	Placebo	8.2		percentage of patients

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sulvecaltamide	83
Overall Study	STARTED	Placebo	86
Overall Study	COMPLETED	Sulvecaltamide	65
Overall Study	COMPLETED	Placebo	72
Overall Study	NOT COMPLETED	Sulvecaltamide	18
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary tract infection	Infections and infestations	Sulvecaltamide	3	83
other	Urinary tract infection	Infections and infestations	Placebo	7	86
other	Dizziness	Nervous system disorders	Sulvecaltamide	12	83
other	Dizziness	Nervous system disorders	Placebo	7	86
other	Somnolence	Nervous system disorders	Sulvecaltamide	11	83
other	Somnolence	Nervous system disorders	Placebo	2	86
other	Headache	Nervous system disorders	Sulvecaltamide	5	83
other	Headache	Nervous system disorders	Placebo	3	86
other	Insomnia	Psychiatric disorders	Sulvecaltamide	5	83
other	Insomnia	Psychiatric disorders	Placebo	0	86

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sulvecaltamide	0	83
Total, all-cause mortality	Placebo	0	86
Total, other adverse events	Sulvecaltamide	36	83
Total, other adverse events	Placebo	19	86
Total, serious adverse events	Sulvecaltamide	4	83
Total, serious adverse events	Placebo	2	86

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sulvecaltamide vs Placebo: deaths from any cause	Trial comparisons
Sulvecaltamide vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05642442

GET https://conductscience.org/api/trials/v1/NCT05642442/events?page=2

API reference For AI assistants