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
TerminatedPhase 2Results postedLast updated 1 July 2022
What this trial tests
Phase 2 trial testing Pridopidine in Parkinson Disease in 23 participants. Terminated before completion.
Adults 30 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS ScorePrimary· 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, 0-2
Baseline
Group
Value
95% CI
Pridopidine Total
32.0
± 10.44
Placebo
35.9
± 6.44
Visit 5
Group
Value
95% CI
Pridopidine Total
14.7
± 5.13
Placebo
26.1
± 11.02
Change from baseline at Visit 5
Group
Value
95% CI
Pridopidine Total
-17.3
± 6.03
Placebo
-9.7
± 9.43
Adverse events — posted to ClinicalTrials.gov
Time frame: From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multicenter, randomized, three-arm, parallel-group, double-blind, placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients with Parkinson Disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04615923 — HEALEY ALS Platform Trial - Regimen D Pridopidine
· Phase 2, PHASE3
· completed
NCT04556656 — PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
· Phase 3
· completed
NCT02494778 — A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
· Phase 2
· terminated
NCT02006472 — A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Hu
· Phase 2
· completed
NCT06069934 — A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (
· no longer available
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Other Prilenia trials
Trials by the same sponsor.
NCT04556656 — PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
· Phase 3
· completed
NCT03019289 — A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers an
· Phase 1
· completed
NCT02494778 — A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
· Phase 2
· terminated
NCT02006472 — A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Hu
· Phase 2
· completed
NCT01306929 — Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prilenia
Last refreshed: 1 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03922711.