Trial · NCT03101241

A Phase 2 RCT Study of CX-8998 for Essential Tremor

NCT03101241, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2021-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 RCT Study of CX-8998 for Essential Tremor. Trials, record NCT03101241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03101241

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Trial

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

Title: A Phase 2 RCT Study of CX-8998 for Essential Tremor
NCT number: NCT03101241
Status: Completed
Phases: Phase 2
Enrollment: 95 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Essential Tremor
Interventions: CX-8998, Placebo
First posted: 2017-04-05
Last updated: 2021-11-23
Results first posted: 2021-10-22

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score	Baseline and Day 28 post-dose.	The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) was used to assess the efficacy of CX-8998 in reducing essential tremor as scored by the independent video raters. TETRAS-PS quantifies tremor in the head, face, voice, limbs, and trunk. The overall subscale score ranges from a minimum of 0 to a maximum of 64. A lower score is indicative of improvement and a better outcome.
Primary	Change From Baseline to Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS)	Baseline up to Day 28 post-dose.	The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) was used to assess the efficacy of CX-8998 in reducing essential tremor as scored by the independent video raters. TETRAS-PS quantifies tremor in the head, face, voice, limbs, and trunk. The overall subscale score ranges from a minimum of 0 to a maximum of 64. A decrease or negative change in the score is indicative of improvement in outcome.
Secondary	Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	Baseline and Day 28 post-dose.	TETRAS-ADL subscale assesses items such as eating and drinking, dressing and personal hygiene, carrying items, and finer motor skills. Each item is rated on a scale for 0 to 4 on which 0 = normal activity and 4 = severe abnormality. The sum of the individual scores provides an overall score, which ranges from a minimum of 0 to a maximum of 48. A lower score is indicative of improvement or a better outcome.
Secondary	Change From Baseline to Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	Baseline up to Day 28 post-dose.	TETRAS-ADL subscale assesses items such as eating and drinking, dressing and personal hygiene, carrying items, and finer motor skills. Each item is rated on a scale for 0 to 4 on which 0 = normal activity and 4 = severe abnormality. The sum of the individual scores provides an overall score, which ranges from a minimum of 0 to a maximum of 48. A decrease or negative change in score is indicative of improvement or a better outcome.
Secondary	Baseline and Day 28 in the Kinesia ONE Score	Baseline and Day 28 post-dose.	Kinesia ONE was developed to provide a quantitative measurement of motor symptoms in individuals with Parkinson's disease. Scores are presented as the sum of the scores of the left and right hands. A total of 4 tasks were performed on the left side and then on the right side to assess resting, postural, kinetic, and lateral wing beating tremor. Values for each test range from 0 (no tremor) to 4 (severe tremor). The total overall score is the sum of all individual items and ranges from a minimum of 0 to a maximum of 32. A lower score is indicative of improvement or a better outcome.
Secondary	Change From Baseline to Day 28 in the Kinesia ONE Score	Baseline up to Day 28 post-dose.	Kinesia ONE was developed to provide a quantitative measurement of motor symptoms in individuals with Parkinson's disease. Scores are presented as the sum of the scores of the left and right hands. A total of 4 tasks were performed on the left side and then on the right side to assess resting, postural, kinetic, and lateral wing beating tremor. Values for each test range from 0 (no tremor) to 4 (severe tremor). The total overall score is the sum of all individual items and ranges from a minimum of 0 to a maximum of 32. A decrease or negative change in score is indicative of improvement or a better outcome.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score	Baseline and Day 28 post-dose.	TETRAS-PS was assessed using the Full Analysis Set. The number analyzed by Day 28 decreased due to participants that did not complete the study to that time point.	score on a scale	MEAN
PRIMARY	Change From Baseline to Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS)	Baseline up to Day 28 post-dose.	TETRAS-PS was assessed using the Full Analysis Set. The number analyzed by Day 28 decreased due to participants that did not complete the study to that time point.	score on a scale	MEAN
SECONDARY	Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	Baseline and Day 28 post-dose.	TETRAS-ADL score was assessed using the Full Analysis Set. The number analyzed by Day 28 decreased due to participants that did not complete the study to that time point.	score on a scale	MEAN
SECONDARY	Change From Baseline to Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	Baseline up to Day 28 post-dose.	TETRAS-ADL score was assessed using the Full Analysis Set. The number analyzed by Day 28 decreased due to participants that did not complete the study to that time point.	score on a scale	MEAN
SECONDARY	Baseline and Day 28 in the Kinesia ONE Score	Baseline and Day 28 post-dose.	Kinesia ONE score was assessed using the Full Analysis Set. The number analyzed by Day 28 decreased due to participants that did not complete the study to that time point.	score on a scale	MEAN
SECONDARY	Change From Baseline to Day 28 in the Kinesia ONE Score	Baseline up to Day 28 post-dose.	Change from baseline to Day 28 in the Kinesia ONE Score was assessed using the Full Analysis Set. The number analyzed by Day 28 decreased due to participants that did not complete the study to that time point.	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	Category	Value	Spread	Units
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score	CX-8998	Baseline	22.7	Standard Deviation 6.44	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score	Placebo	Baseline	22.8	Standard Deviation 5.84	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score	CX-8998	Day 28	21.1	Standard Deviation 6.71	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) Total Score	Placebo	Day 28	20.7	Standard Deviation 7.96	score on a scale
Change From Baseline to Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS)	CX-8998		-1.6	Standard Deviation 4.36	score on a scale
Change From Baseline to Day 28 on The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS)	Placebo		-2.0	Standard Deviation 4.98	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	CX-8998	Baseline	25.7	Standard Deviation 6.00	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	Placebo	Baseline	26.0	Standard Deviation 7.13	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	CX-8998	Day 28	21.5	Standard Deviation 6.44	score on a scale
Baseline and Day 28 on The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS-ADL) Subscale Score	Placebo	Day 28	24.8	Standard Deviation 9.19	score on a scale

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	CX-8998	48
Overall Study	STARTED	Placebo	47
Overall Study	COMPLETED	CX-8998	37
Overall Study	COMPLETED	Placebo	42
Overall Study	NOT COMPLETED	CX-8998	11
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events40

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	Dizziness	Nervous system disorders	CX-8998	10	48
other	Dizziness	Nervous system disorders	Placebo	3	47
other	Headache	Nervous system disorders	CX-8998	4	48
other	Headache	Nervous system disorders	Placebo	2	47
other	Disturbance in attention	Nervous system disorders	CX-8998	2	48
other	Disturbance in attention	Nervous system disorders	Placebo	1	47
other	Dysgeusia	Nervous system disorders	CX-8998	2	48
other	Dysgeusia	Nervous system disorders	Placebo	0	47
other	Paraesthesia	Nervous system disorders	CX-8998	2	48
other	Paraesthesia	Nervous system disorders	Placebo	1	47

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CX-8998	0	48
Total, all-cause mortality	Placebo	0	47
Total, other adverse events	CX-8998	28	48
Total, other adverse events	Placebo	19	47
Total, serious adverse events	CX-8998	1	48
Total, serious adverse events	Placebo	0	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31244760	DERIVED

Source PubMed

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
CX-8998 vs Placebo: deaths from any cause	Trial comparisons
CX-8998 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/NCT03101241

GET https://conductscience.org/api/trials/v1/NCT03101241/events?page=2

API reference For AI assistants