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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT03956979
• Date of registration: 17/05/2019
• Prospective Registration: Yes
• Primary sponsor: Contera Pharma
• Public title: A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia ASTORIA
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010
• Date of first enrolment: July 22, 2019
• Target sample size: 81
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03956979
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France, Germany, Italy, Korea, Republic of, Spain

Contacts

• Name: Contera Clinical Development
• Affiliation: Contera Pharma

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dyskinesias

Intervention(s)

Drug: JM-010 group B

Drug: Placebos

Drug: JM-010 group A

Primary Outcome(s)

Unified Dyskinesia Rating Scale (UDysRS) [Time Frame: 12 Weeks]

Secondary Outcome(s)

Hauser diary [Time Frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks]

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks]

Clinician's Global Impression-Change (CGI-C) score [Time Frame: 12 Weeks]

Unified Dyskinesia Rating Scale (UDysRS) [Time Frame: 2 Weeks, 4 Weeks, 8 Weeks]

Secondary ID(s)

2017-003415-19

JM-010CS03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bukwang Pharmaceutical