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NCT03956979: ASTORIA

A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia

Completed Phase 2 Last updated 17 June 2024
What this trial tests

Phase 2 trial testing JM-010 group A in Dyskinesias in 89 participants. Completed in 21 March 2024.

Timeline
22 July 2019
Primary endpoint
7 March 2024
21 March 2024

Quick facts

Lead sponsorContera Pharma
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment89
Start date22 July 2019
Primary completion7 March 2024
Estimated completion21 March 2024
Sites5 locations across France, Italy, Germany, South Korea, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Contera Pharma — full company profile →

Who can join

Adults 18 to 85, any sex, with Dyskinesias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.

Publications & conference data

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

  1. Pathophysiological Mechanisms and Experimental Pharmacotherapy for L-Dopa-Induced Dyskinesia.
    Fabbrini A, Guerra A. · · 2021 · cited 34× · PMID 33953618 · DOI 10.2147/jep.s265282
  2. 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
  3. An Update on Nondopaminergic Treatments for Motor and Non-motor Symptoms of Parkinson's Disease.
    Jing XZ, Yuan XZ, Luo X, Zhang SY, et al · · 2023 · cited 21× · PMID 35193486 · DOI 10.2174/1570159x20666220222150811
  4. 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
  5. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA.
    McFarthing K, Prakash N, Simuni T. · · 2019 · cited 12× · PMID 31356217 · DOI 10.3233/jpd-199002
  6. The effect of 5-HT<sub>1A</sub> receptor agonists on the entopeduncular nucleus is modified in 6-hydroxydopamine-lesioned rats.
    Vegas-Suárez S, Aristieta A, Requejo C, Bengoetxea H, et al · · 2021 · cited 4× · PMID 33686657 · DOI 10.1111/bph.15437
  7. Motor cortico-nigral and cortico-entopeduncular information transmission and its modulation by buspirone in control and after dopaminergic denervation.
    Vegas-Suárez S, Morera-Herreras T, Requejo C, Lafuente JV, et al · · 2022 · cited 3× · PMID 36133803 · DOI 10.3389/fphar.2022.953652

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