Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA (ASTORIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03956979
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Bukwang Pharmaceutical
Information provided by (Responsible Party):
Bukwang Pharmaceutical ( Contera Pharma )

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.

Condition or disease Intervention/treatment Phase
Dyskinesias Drug: JM-010 A group Drug: JM-010 B group Drug: Placebos Phase 2

Detailed 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 buspirone and zolmitriptan (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 2weeks, including pharmacokinetic (PK) sub-study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, double-dummy.
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JM-010 A group
As JM-010 4/0.8mg dose fixed combination drug(tablet) +Placebo 2
Drug: JM-010 A group
JM-010 fixed combination drug(4/0.8mg) + Placebo 2
Other Name: JM-010

Experimental: JM-010 B group
As JM-010 8/0.8mg dose fixed combination drug(tablet) + Placebo 1
Drug: JM-010 B group
JM-010 fixed combination drug (8/0.8mg) + Placebo 1
Other Name: JM-010

Placebo Comparator: Placebo
Double-dummy - 2 tablets = Placebo 1 +Placebo 2
Drug: Placebos
Placebo 1 + Placebo 2
Other Name: Placebo




Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 12 Weeks ]
    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.


Secondary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 2 Weeks, 4 Weeks, 8 Weeks ]
    To compare the efficacy of JM-010 to that of placebo therapy by evaluating the total score changes from Baseline to Weeks 2, 4, 8 in the sum of the items comprising UDysRS, dyskinesia rating scale from 0-104. Higher score means more dyskinesia.

  2. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks ]
    To compare the efficacy of JM-010 to that of placebo therapy as measured by the sum of the MDS-UPDRS Part III score changes from Baseline to Weeks 2, 4, 8, 12. The score range is 0-132, where a higher score means more severe motor impairment.

  3. Clinician's Global Impression-Change (CGI-C) score [ Time Frame: 12 Weeks ]
    To compare the efficacy of JM-010 to that of placebo therapy in relation to improvement in clinician-reported PD symptoms as measured by CGI-C score at Week 12. The CGI-C uses the following ratings: 0=not assessed; 1=very much improved; 2=much improved; 3=a little improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.

  4. Hauser diary [ Time Frame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks ]
    To compare the efficacy of JM-010 to that of placebo therapy as measured by ON time without troublesome dyskinesia changes, OFF time changes, ON time with troublesome dyskinesia changes, Total time with dyskinesia changes from Baseline to Week 2, 4, 8, 12 in Hauser diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956979


Contacts
Layout table for location contacts
Contact: Jihyeon Kim 82-2-828-8099 ji.hyeon.kim@bukwang.co.kr
Contact: Minjung Woo 82-2-828-8088 minjung.woo@bukwang.co.kr

Sponsors and Collaborators
Contera Pharma
Bukwang Pharmaceutical
Investigators
Layout table for investigator information
Principal Investigator: Alexander Storch, PhD. Dr. Universitätsklinik Rostock - Hospital

Layout table for additonal information
Responsible Party: Contera Pharma
ClinicalTrials.gov Identifier: NCT03956979     History of Changes
Other Study ID Numbers: JM-010CS03
2017‐003415‐19 ( EudraCT Number )
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms