A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s disease
- Conditions
- Parkinson’s disease levodopa induced dyskinesia (PD-LID)MedDRA version: 18.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-000373-13-DE
- Lead Sponsor
- Amarantus BioScience Holdings, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
A patient will be invited to participate if he/she meets the following inclusion criteria:
1. willing and able to provide written informed consent
2. age 30 to 85 years, inclusive
3. outpatient with idiopathic PD according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
4. on a PD treatment regimen with a stable dose of anti-Parkinsonian medication for at least four weeks before the Screening Visit (levodopa, DDIs, COMT inhibitors, dopamine agonists and MAO-B inhibitors)
5. treated with a daily levodopa dose (immediate or extended release formulation) more than 300 mg per day divided into at least three doses
6. treated with levodopa for at least three years prior to study entry
7. has been experiencing levodopa induced peak-dose dyskinesia for at least three months prior to study entry
8. experiences disabling dyskinesia (Screening Visit MDS-UPDRS Part IV question 4.2 score =2)
9. has dyskinesia for, on average, >25% of the waking day based on patient reported dyskinesia (tablet diaries) during the second week of the screening period
10. has the ability to communicate adequately with the study staff and to comply with the requirements of he entire study, with the help of a caregiver if applicable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
A patient will be excluded from study participation if he/she meets any of the following
criteria:
1. inability to use the Kinesia 360 system (tablet or motion sensors) correctly,
diaries not completed in a timely manner or two or more hours’ worth of missing waking day entries” or times PD-LID medication taken missing
2. surgical treatment for PD (e.g. DBS), within the last six months or planned during the study
3. unstable co-existing psychiatric disease including psychosis, depression or
cognitive impairment that, according to the Investigator, could interfere with the conduct of the study
4. has an MMSE score of <24
5. has a known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the Investigator, may affect the patient’s safety
6. has moderate or severe renal or severe hepatic impairment and/or has clinically significant abnormal laboratory parameters at screening, in particular, liver or renal function tests greater than 1.5 times the upper limit of normal (ULN) or any other clinically significant biochemical or hematological abnormality as determined by the Investigator
7. treatment with selective serotonin re-uptake inhibitors (SSRI) or any combined serotonin-norepinephrine re-uptake inhibitors (SNRI) such as tryptizol, citalopram, escitalopram, sertraline, mianserin, mirtazapin, paroxetin, venlafaxine and St John’s Wort, within four weeks prior to the Screening Visit.
8. other medication with the potential for drug-interactions (MAO-A inhibitors,
apomorphine, aripiprazol, carbamazepine, clozapine, phenytoin, tramadol,
quetiapine, varfaine, valproic acid). Patients taking amantadine may be included if the amantadine is being used according to its indication for the treatment of PD and not specifically for dyskinesia and the dose remains stable throughout the trial. Patients taking amantadine will comprise no more than 25% of the study population
9. No clinically significant 12-lead ECG abnormalities and with a QTc value of
<450 ms for men and <460 ms for women.
10. has a current history of a clinically significant and uncontrolled medical condition that may affect the safety of the patient or preclude adequate participation in the study, including but not limited to orthostatic hypotension causing syncope, uncontrolled ischemic heart disease, uncontrolled brady- or tachy-arrhythmias, chronic obstructive pulmonary disease, diabetes and epilepsy
11. is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, doublebarrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening
12. has received any other investigational medicinal product within 30 days of Screening
13. is a member of, or relative of, the study site staff and/or employees or consultants of Amarantus BioScience
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method