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

NCT03956979 | Completed Phase 2

• 2 other identifiers: JM-010CS032017-003415-19
• Study Type: interventional
• Target: 89
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Dyskinesias

Outcome Measures

Primary Outcomes (1)

• Unified Dyskinesia Rating Scale (UDysRS)

  To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 12 in the sum of the items comprising UDysRS. The scoring range is 0-104, and a higher score indicates more severe dyskinesia.

  12 Weeks

Secondary Outcomes (4)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks

• Clinician's Global Impression-Change (CGI-C) score

  12 Weeks

• Hauser diary

  2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks

• Unified Dyskinesia Rating Scale (UDysRS)

  2 Weeks, 4 Weeks, 8 Weeks

Study Arms (3)

JM-010 group A

EXPERIMENTAL

Group A (JM-010 dose fixed combination drug(tablet)) +Placebo 2

Drug: JM-010 group A

JM-010 group B

EXPERIMENTAL

Group B (JM-010 8/0.8mg dose fixed combination drug(tablet)) + Placebo 1

Drug: JM-010 group B

Placebo

PLACEBO COMPARATOR

Double-dummy - 2 tablets = Placebo 1 +Placebo 2

Drug: Placebos

Interventions

JM-010 group A DRUG

JM-010 fixed combination drug (Group A) + Placebo 2

Also known as: JM-010

JM-010 group A

JM-010 group B DRUG

JM-010 fixed combination drug (Group B) + Placebo 1

Also known as: JM-010

JM-010 group B

Placebos DRUG

Placebo 1 + Placebo 2

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contera Pharma: lead
• Bukwang Pharmaceutical: collaborator

Study Sites (5)

Contera Investigational site_FR

Toulouse, France

Location

Contera Investigational site_DE

Rostock, Germany

Location

Contera Investigational site_IT

Roma, Italy

Location

Contera Investigational site_KOR

Seoul, South Korea

Location

Contera Investigational site_ES

Madrid, Spain

Location

Related Publications (1)

• McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.

  PMID: 31356217 DERIVED

MeSH Terms

Conditions

Dyskinesias

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Contera Clinical Development

  Contera Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, double-dummy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: July 22, 2019
• Primary Completion: March 7, 2024
• Study Completion: March 21, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); FR (1); DE (1); IT (1); ES (1)