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NCT05116813 · ClinicalTrials.gov registry record · Phase 2

Open-label Safety Study of Dipraglurant (ADX48621) in 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
17
Enrollment target

NCT05116813: Clinical Trial Phase 2 study, sponsored by Addex Pharma S.A..

NCT05116813 is a Phase 2 study that was terminated before completion, run by Addex Pharma S.A.. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05116813, a Phase 2 study, was terminated before completion, sponsored by Addex Pharma S.A..

TERMINATED
Registry status
Phase 2
Development phase
17 participants
Enrollment target

Study Summary

This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.

Primary Outcome

Testing the safety and tolerability of dipraglurant in patients with Parkinson's Disease Levodopa-induced dyskinesia based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study.

Interventions

  • DRUG Dipraglurant

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-10-25
Est. Completion 2022-08-15
Phase Phase 2
Addex Pharma S.A.

5 total trials

Why NCT05116813 stopped before completion

NCT05116813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which Dipraglurant is the first listed.

NCT05116813 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05116813 about?

NCT05116813 is a clinical study titled "Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy". This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.

What is the current status of trial NCT05116813?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2021-10-25. Estimated completion is 2022-08-15.

What interventions are being tested in trial NCT05116813?

The interventions under investigation include: Dipraglurant (DRUG).

Who is sponsoring clinical trial NCT05116813?

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 NCT05116813's enrollment target sits among peer trials

17 1903rd of 2000 higher than 93 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 NCT05116813, the US trial registry maintained by the National Library of Medicine. NCT05116813 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.