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

Last updated: June 14, 2024
Sponsor: Contera Pharma
Overall Status: Completed

Phase

2

Condition

Dyskinesias

Treatment

JM-010 group A

Placebos

JM-010 group B

Clinical Study ID

NCT03956979
JM-010CS03
2017-003415-19
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is able to read, understand, and provide written, dated informed consent prior toScreening Visit.

  • Is male or female, between 18 and 80 years of age at Screening Visit.

  • Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS)Brain Bank Clinical Diagnostic Criteria and requires treatment with and showsresponsiveness to levodopa.

  • Has experienced dyskinesia over a period of at least 3 months prior to ScreeningVisit

  • Has stable peak-effect dyskinesia

  • Has more than one hour of "ON" time with troublesome dyskinesia during daily wakinghours on a 24-hour PD subject diary

  • Is on a stable levodopa dosing regimen requiring at least 3 dose administrations butno more than 6 dose administrations per day

Exclusion

Exclusion Criteria:

  • Has undergone surgery for the treatment of PD

  • Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse orDependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),

  • Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses

  • Has a significant risk for suicidal behaviour in the opinion of the investigatorduring the course of their participation in the study

  • Has current seizure disorders (other than febrile seizures in childhood) requiringtreatment with anticonvulsants.

  • Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease orany acute brain trauma requiring treatment with anti-convulsant therapy within 5years prior Visit 2, Week 0 (Baseline Visit).

  • Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akatheticdyskinesia without peak-dose dyskinesia.

Other criteria related to other medical conditions to be referred to the protocol.

Study Design

Total Participants: 89
Treatment Group(s): 3
Primary Treatment: JM-010 group A
Phase: 2
Study Start date:
July 22, 2019
Estimated Completion Date:
March 21, 2024

Study Description

This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study.

Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study.

Subjects will continue with their usual levodopa treatment regimen for the duration of study participation.

The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.

Connect with a study center

  • Contera Investigational site_FR

    Toulouse,
    France

    Site Not Available

  • Contera Investigational site_DE

    Rostock,
    Germany

    Site Not Available

  • Contera Investigational site_IT

    Roma,
    Italy

    Site Not Available

  • Contera Investigational site_KOR

    Seoul,
    Korea, Republic of

    Site Not Available

  • Contera Investigational site_ES

    Madrid,
    Spain

    Site Not Available

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