NCT04857359

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

Terminated Phase 2, PHASE3 Last updated 6 August 2025

What this trial tests

Phase 2, PHASE3 trial testing Dipraglurant in Parkinson Disease in 25 participants. Terminated before completion.

Timeline

6 August 2021

Primary endpoint
17 June 2022

15 August 2022

Quick facts

Lead sponsor	Addex Pharma S.A.
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	25
Start date	6 August 2021
Primary completion	17 June 2022
Estimated completion	15 August 2022
Sites	41 locations across United States

Drugs / interventions tested

• Dipraglurant — full drug profile →
• Placebo

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Dyskinesia, Drug-Induced — all drugs for Dyskinesia, Drug-Induced →
• Dyskinesias — all drugs for Dyskinesias →

Sponsor

Addex Pharma S.A. — full company profile →

Who can join

Adults 30 to 85, any sex, with Parkinson Disease or Dyskinesia, Drug-Induced. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
   Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
2. Targeting the Type 5 Metabotropic Glutamate Receptor: A Potential Therapeutic Strategy for Neurodegenerative Diseases?
   Budgett RF, Bakker G, Sergeev E, Bennett KA, et al · · 2022 · cited 24× · PMID 35645791 · DOI 10.3389/fphar.2022.893422
3. Unraveling the intercellular communication disruption and key pathways in Alzheimer's disease: an integrative study of single-nucleus transcriptomes and genetic association.
   Liu A, Fernandes BS, Citu C, Zhao Z. · · 2024 · cited 22× · PMID 38167548 · DOI 10.1186/s13195-023-01372-w
4. Newly Approved and Investigational Drugs for Motor Symptom Control in Parkinson's Disease.
   Di Luca DG, Reyes NGD, Fox SH. · · 2022 · cited 21× · PMID 35841520 · DOI 10.1007/s40265-022-01747-7
5. Parkinson's disease therapy: what lies ahead?
   Wolff A, Schumacher NU, Pürner D, Machetanz G, et al · · 2023 · cited 19× · PMID 37147404 · DOI 10.1007/s00702-023-02641-6
6. Lipid-based nanoparticles for drug delivery in Parkinson's disease.
   Cai H, Liu D, Xue WW, Ma L, et al · · 2024 · cited 7× · PMID 39654878 · DOI 10.1515/tnsci-2022-0359
7. Targeting Striatal Glutamate and Phosphodiesterases to Control L-DOPA-Induced Dyskinesia.
   Kochoian BA, Bure C, Papa SM. · · 2023 · cited 4× · PMID 38067182 · DOI 10.3390/cells12232754
8. Pharmacology, Signaling and Therapeutic Potential of Metabotropic Glutamate Receptor 5 Negative Allosteric Modulators.
   Kos JA, Langiu M, Hellyer SD, Gregory KJ. · · 2024 · cited 3× · PMID 39698283 · DOI 10.1021/acsptsci.4c00213