Clinical trial NCT03956979: A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyskinesias
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Bukwang Pharmaceutical
First posted: 2019-05-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
measure: Clinician's Global Impression-Change (CGI-C) score
timeFrame: 12 Weeks
measure: Hauser diary
timeFrame: 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks
measure: Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: 2 Weeks, 4 Weeks, 8 Weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Contera Investigational site_FR
city: Rostock
country: Germany
facility: Contera Investigational site_DE
city: Roma
country: Italy
facility: Contera Investigational site_IT
city: Seoul
country: Korea, Republic of
facility: Contera Investigational site_KOR
city: Madrid
country: Spain
facility: Contera Investigational site_ES
Study officials:
affiliation: Contera Pharma
name: Contera Clinical Development
role: STUDY_DIRECTOR
References:
citation: 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.