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NCT04857359 · ClinicalTrials.gov registry record · Phase 2

Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

A Phase 2 study, sponsored by Addex Pharma S.A..

Terminated
Registry status
Phase 2
Development phase
25
Enrollment target

NCT04857359: Clinical Trial Phase 2 study, sponsored by Addex Pharma S.A..

NCT04857359 is a Phase 2 study that was terminated before completion, run by Addex Pharma S.A.. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04857359, a Phase 2 study, was terminated before completion, sponsored by Addex Pharma S.A..

TERMINATED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

Primary Outcome

The UDysRS is a dyskinesia rating scale scored from 0-104 that evaluates involuntary movements associated with PD. A higher score indicates more severe dyskinesia.

Interventions

  • DRUG Placebo
  • DRUG Dipraglurant

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2021-08-06
Est. Completion 2022-08-15
Phase Phase 2
Addex Pharma S.A.

5 total trials

Why NCT04857359 stopped before completion

NCT04857359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04857359 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04857359 about?

NCT04857359 is a clinical study titled "Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy". This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rati...

What is the current status of trial NCT04857359?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2021-08-06. Estimated completion is 2022-08-15.

What interventions are being tested in trial NCT04857359?

The interventions under investigation include: Placebo (DRUG), Dipraglurant (DRUG).

Who is sponsoring clinical trial NCT04857359?

This trial is sponsored by Addex Pharma S.A., which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04857359's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04857359, the US trial registry maintained by the National Library of Medicine. NCT04857359 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.