Trial Outcomes & Findings for A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease (NCT NCT05642442)

NCT ID: NCT05642442

Last Updated: 2026-01-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 169 participants
• Primary outcome timeframe: Baseline to Week 17
• Results posted on: 2026-01-15

Participant Flow

A total of 169 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment at 43 sites in the United States, Germany, Poland, and Spain.

Participant milestones

Measure	Sulvecaltamide Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Overall Study STARTED	83	86
Overall Study COMPLETED	65	72
Overall Study NOT COMPLETED	18	14

Reasons for withdrawal

Measure	Sulvecaltamide Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Overall Study Adverse Event	0	1
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	13	9
Overall Study Other	5	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sulvecaltamide n=83 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=86 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.	Total n=169 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 7.79 • n=14 Participants	67.9 years STANDARD_DEVIATION 7.93 • n=10 Participants	67.7 years STANDARD_DEVIATION 7.84 • n=24 Participants
Sex: Female, Male Female	22 Participants n=14 Participants	32 Participants n=10 Participants	54 Participants n=24 Participants
Sex: Female, Male Male	61 Participants n=14 Participants	54 Participants n=10 Participants	115 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	3 Participants n=14 Participants	1 Participants n=10 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	3 Participants n=14 Participants	3 Participants n=10 Participants	6 Participants n=24 Participants
Race (NIH/OMB) White	76 Participants n=14 Participants	82 Participants n=10 Participants	158 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline to Week 17

Population: Mean TETRAS composite outcome score was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score	-6.4 score on a scale Standard Deviation 5.39	-5.3 score on a scale Standard Deviation 5.73

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: CGI-S was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)	54.6 percentage of participants	40.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: TETRAS-ADL was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)	-7.5 score on scale Standard Deviation 7.04	-5.8 score on scale Standard Deviation 6.48

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: PGI-S was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)	54.0 percentage of patients	43.7 percentage of patients

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: PGI-C was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17	23.9 percentage of patients	8.2 percentage of patients

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: CGI-C was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Percentage of Participants Who Were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17	15.7 percentage of patients	8.1 percentage of patients

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: TETRAS-PS was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Performance Subscale (TETRAS-PS)	-4.2 score on a scale Standard Deviation 5.41	-5.9 score on a scale Standard Deviation 6.37

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: TETRAS total score was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=72 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=75 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Change From Baseline to Week 17 on TETRAS Total Score (TETRAS-ADL + TETRAS-PS)	-11.7 score on a scale Standard Deviation 10.15	-11.7 score on a scale Standard Deviation 10.48

SECONDARY outcome

Timeframe: Baseline to Week 17

Population: MDS-UPDRS was assessed in participants with available data in the Full Analysis Set.

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.

Outcome measures

Measure	Sulvecaltamide n=65 Participants Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=73 Participants Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Change From Baseline to Week 17 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Tremor Score	-3.5 score on a scale Standard Deviation 3.80	-3.1 score on a scale Standard Deviation 5.08

Adverse Events

Sulvecaltamide

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sulvecaltamide n=83 participants at risk Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=86 participants at risk Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Injury, poisoning and procedural complications Fall	1.2% 1/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	0.00% 0/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Nervous system disorders Cerebrovascular accident	1.2% 1/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	0.00% 0/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	1.2% 1/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Cardiac disorders Cardiac failure	0.00% 0/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	1.2% 1/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Gastrointestinal disorders Dysphagia	1.2% 1/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	0.00% 0/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	1.2% 1/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Psychiatric disorders Anxiety	1.2% 1/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	0.00% 0/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Injury, poisoning and procedural complications Lumbar vertebral fracture	1.2% 1/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	0.00% 0/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.

Other adverse events

Measure	Sulvecaltamide n=83 participants at risk Participants who received an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.	Placebo n=86 participants at risk Participants who received a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
Infections and infestations Urinary tract infection	3.6% 3/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	8.1% 7/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Nervous system disorders Dizziness	14.5% 12/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	8.1% 7/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Nervous system disorders Somnolence	13.3% 11/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	2.3% 2/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Nervous system disorders Headache	6.0% 5/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	3.5% 3/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.
Psychiatric disorders Insomnia	6.0% 5/83 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.	0.00% 0/86 • Adverse events were collected from baseline up to 14 days after the last dose of study intervention. up to 19 weeks.

Additional Information

Director Clinical Trial Disclosure & Transparency

Jazz Pharmaceuticals, Inc.

Phone: +1 215-832-3750

Email: ClinicalTrialDisclosure@JazzPharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place