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

  • STATUS
    Recruiting
  • End date
    Mar 25, 2022
  • participants needed
    81
  • sponsor
    Contera Pharma
Updated on 25 November 2021
combinations
levodopa
dyskinesia
parkinson's disease

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.

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.

Details
Condition Dyskinesia, Parkinson's disease, Dyskinesias, dyskinesis, parkinson's, parkinson disease
Treatment placebos, JM-010 A group, JM-010 B group, JM-010 group A, JM-010 group B
Clinical Study IdentifierNCT03956979
SponsorContera Pharma
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is able to read, understand, and provide written, dated informed consent prior to Screening 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 shows responsiveness to levodopa
Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
Has stable peak-effect dyskinesia
Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary
Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day

Exclusion Criteria

Has undergone surgery for the treatment of PD
Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, 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 investigator during the course of their participation in the study
Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants
Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit)
Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia
Other criteria related to other medical conditions to be referred to the
protocol
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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