Dyskinesias related to levodopa treatment in Parkinson´s disease
Conditions
Interventions
Product Name: Eltoprazine HCl
Product Code: Eltoprazine HCl
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
PsychoGenics Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Parkinson’s disease, defined according to the UK Brain Bank Criteria. Bradykinesia should be combined with one of resting tremor, rigidity or postural imbalance. - Duration of L-dopa treatment of at least 3 years. - Significant dyskinesias after L-dopa dosages according to clinical experience. - Significant dyskinesias in a screening single dose L-dopa challenge using two dyskinesia rating scales. The screening test is performed with a challenge dose of 150% of the normal regular dose of L-Dopa the patient is about to take at the time of testing. If no dyskinesias appear during the first challenge, the challenge may be repeated on an alternate day (and) significant dyskinesias in a patient self-administered diary with 3 levels with 3 grades (off, on without dyskinesias, on with hyperkinesias) after the challenge dose has been given. Patients can be included if one of the two challenge tests are positive and diary is positive for dyskinesias. - Over 18 years of age. - This inclusion criterion (2) applied to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) only. Must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study. - Signed informed consent. - Must be able to communicate effectively with the investigator and study coordinator. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Exclusion criteria for Parkinson’s disease according to the UK Brain Bank Criteria for Parkinson’s disease. - Fulfillment of any other atypical parkinsonism diagnosis according to published criteria for multiple system atrophy, progressive supranucelar paresis, dementia with Lewy body, corticobasal gangliotic disease and dementia with Parkinson’s disease. - Any suspected secondary parkinsonism: drug induced parkinsonism; toxin-induced parkinsonism; trauma-induced parkinsonism; normal pressure hydrocephalus and vascular parkinsonism. - Ongoing treatment with any anti-dopaminergic medications (neuroleptics) for the past 6 months. - Ongoing treatment with any selective serotonin re-uptake inhibitors (SSRI) for the past 4 weeks. - Ongoing treatment with any combined norepinephrine and serotonin re-uptake inhibitors (SNSRI) for the past 4 weeks. - Significant depression defined as > 18 in the Montgomery Åsberg Depression Rating Scale combined with a clinical evaluation as to any clinical relevant depression. - Pregnancy or breast-feeding. - Reduced kidney function; defined as a creatinine level > 120 umol/L. - Reduced liver function, defined as ASAT >1,0 ukat/L, or ALAT > 1,0 ukat/L, or GT > 1,6 ukat/L, or total bilirubin> 30 umol/L, eller ALP> 6,0 ukat/L. - History of any other medical condition thought to interfere with the study or study medication (i.e., recent myocardial infarction, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure > 180 mmHg), ongoing severe infection). - Receipt of an investigational drug within 30 days or 5 half-lives of the drug, whichever is longer, prior to entering this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effective dose of eltoprazine HCl on the suppression of dyskinesias in L-dopa treated patients while sustaining the normal treatment effect of L-Dopa.;Secondary Objective: To assess the safety & tolerability of eltoprazine HCl in adults with Parkinson’s Disease. ;Primary end point(s): To determine the effective dose of eltoprazine on the suppression of dyskinesias in L-dopa treated patients while sustaining the normal treatment effect of L-Dopa using the following efficacy measures: - Change in the highest observed Unified Parkinson’s Disease Rating Scale (UPDRS) III prior to and after study medication is given, to indicate a deterioration of the normal treatment effect of L-dopa. - Population mean values for the change in dyskinesias ratings between the placebo and screening baseline values and any of the eltoprazine dosages used, calculated as the area-under-the-curve, AuC, for the CDRS ratings over 3 hours after L-dopa and study medication intake. - Population mean values for the change in dyskinesias ratings between the placebo and screening baseline values and any of the eltoprazine dosages used for the peak of dose for Rush DRS ratings over 3 hours after L-dopa and study medication intake. | — |
Countries
Sweden
Outcome results
None listed