Trial · NCT03922711

A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

NCT03922711, Phase 2, Terminated, Prilenia; results first posted 2022-07-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease. Trials, record NCT03922711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03922711

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Trial

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

Title: A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease
NCT number: NCT03922711
Status: Terminated
Phases: Phase 2
Enrollment: 23 participants, actual
Lead sponsor: Prilenia
Conditions: Parkinson Disease
Interventions: Pridopidine, Placebo
First posted: 2019-04-22
Last updated: 2022-07-01
Results first posted: 2022-07-01
Limitations and caveats: The study was terminated early due to the COVID-19 pandemic.

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit.	Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical \[Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)\] and Objective \[Part 3 (Impairment) and Part 4 (Disability)\] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit.	The primary endpoint was analyzed for the population of patients randomized and on study drug at Visit 5 (Week 8/10). Of the 3 pridopidine patients included, 1 and 2 patients, respectively, received pridopidine 100 and 150 mg. Analysis of these data, separately for each pridopidine dose, is not meaningful or conclusive.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Pridopidine Total	Baseline	32.0	Standard Deviation 10.44	score on a scale
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Placebo	Baseline	35.9	Standard Deviation 6.44	score on a scale
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Pridopidine Total	Visit 5	14.7	Standard Deviation 5.13	score on a scale
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Placebo	Visit 5	26.1	Standard Deviation 11.02	score on a scale
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Pridopidine Total	Change from baseline at Visit 5	-17.3	Standard Deviation 6.03	score on a scale
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	Placebo	Change from baseline at Visit 5	-9.7	Standard Deviation 9.43	score on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pridopidine 100 mg BID	7
Overall Study	STARTED	Pridopidine 150 mg BID	8
Overall Study	STARTED	Placebo	8
Overall Study	Treatment Group Based on Maximal Possible Highest Dose Received (Used for Analysis)	Pridopidine 100 mg BID	12
Overall Study	Treatment Group Based on Maximal Possible Highest Dose Received (Used for Analysis)	Pridopidine 150 mg BID	3
Overall Study	Treatment Group Based on Maximal Possible Highest Dose Received (Used for Analysis)	Placebo	8
Overall Study	COMPLETED	Pridopidine 100 mg BID	3
Overall Study	COMPLETED	Pridopidine 150 mg BID	3
Overall Study	COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Pridopidine 100 mg BID	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events201

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	Events
other	Tinnitus	Ear and labyrinth disorders	Pridopidine 100 mg BID	2	12	2
other	Tinnitus	Ear and labyrinth disorders	Pridopidine 150 mg BID	0	3	0
other	Tinnitus	Ear and labyrinth disorders	Placebo	0	8	0
other	Vertigo	Ear and labyrinth disorders	Pridopidine 100 mg BID	1	12	1
other	Vertigo	Ear and labyrinth disorders	Pridopidine 150 mg BID	0	3	0
other	Vertigo	Ear and labyrinth disorders	Placebo	0	8	0
other	Dry eye	Eye disorders	Pridopidine 100 mg BID	1	12	1
other	Dry eye	Eye disorders	Pridopidine 150 mg BID	1	3	1
other	Dry eye	Eye disorders	Placebo	0	8	0
other	Dry mouth	Gastrointestinal disorders	Pridopidine 100 mg BID	3	12	3

1 to 10 of 201Source ClinicalTrials.gov

See all 201 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pridopidine 100 mg BID	0	12
Total, all-cause mortality	Pridopidine 150 mg BID	0	3
Total, all-cause mortality	Placebo	0	8
Total, other adverse events	Pridopidine 100 mg BID	10	12
Total, other adverse events	Pridopidine 150 mg BID	3	3
Total, other adverse events	Placebo	7	8
Total, serious adverse events	Pridopidine 100 mg BID	0	12
Total, serious adverse events	Pridopidine 150 mg BID	0	3
Total, serious adverse events	Placebo	1	8

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31356217	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 comparisons0

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

None in this release.

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/NCT03922711

GET https://conductscience.org/api/trials/v1/NCT03922711/events?page=2

API reference For AI assistants