NCT03956979CompletedPhase 2
A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 89 (actual)
- First submitted
- 17 May 2019
- Start date
- 22 Jul 2019
- Primary completion date
- 7 Mar 2024
- Lead sponsor
- Contera Pharma
- Diseases
- Parkinson disease
- NCT number
- NCT03956979
- EudraCT number
- 2017-003415-19
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 89
- From 22 Jul 2019 to the primary completion date, 7 Mar 2024
- 5 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has undergone surgery for the treatment of PD
- 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).
Other illness
- 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 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.
Other
- Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Contera Investigational site_DE Coordinator of this site? Confirm its status | Rostock | Germany | Unknown status |
| Contera Investigational site_ES Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Contera Investigational site_FR Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Contera Investigational site_IT Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Contera Investigational site_KOR Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.