TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY

Björn Holmberg0 sites8 target enrollmentDecember 4, 2009

ConditionsParkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries.

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries.
Sponsor: Björn Holmberg
Enrollment: 8
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 4, 2009

End Date

August 25, 2011

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Björn Holmberg

Eligibility Criteria

Inclusion Criteria

•1\. Subjects who fulfill the British Brain Bank diagnostic criteria for definite PD; 2\. Long standing disease duration (more than 5 years); 3\. Moderately disabling dyskinesias during at least 25% of the waking day, despite best medical treatment (UPDRS IV items no. 32 and 33 each \=2\). 4\. Patient can rate on/off time and dyskinesias with at least a 66% concordance between patient and investigator/coordinator in a day in which patient experienced on with and without dyskinesias and off time. In order to be able to complete the home diaries, patients will be instructed in rating themselves in regard to on/off time and dyskinesias. This will be done at screening, before inclusion in the study, in a day in which the patient experiences on with and without dyskinesias and off time. Patients will spend in the clinic at least 4 hours or as long as needed, as judged by the investigator, during which time they will fill in the home diary form every hour, with the investigator performing the same evaluation concomitantly. Only patients eventually attaining at least a 66% concordance between their own and the assessment of the investigator/coordinator will be included in the study. 5\. Subjects have signed the informed consent form.
•6\. Stable antiparkinsonian and antidepressant medication during the last 4 weeks prior to inclusion in the study.
•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

•1\. Significant co\-morbidity including alcohol or drug abuse. Medical problems such as unstable or/and untreated ischemic cardiac disease, diabetes, hypertension, vitamin deficiencies, thyroid diseases.
•2\. Pregnant women.
•3\. Women of childbearing age not on contraceptives.
•4\. Sick sinus syndrome; resting heart rate below 50 beats per minute; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of randomization; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of\> 450 msec for males or\> 470 msec for females); atrio\-ventricular conduction block; other clinically significant heart conditions which would negatively impact on the patient completing the study.
•5\. Clinically significant liver disease and/or an elevation in either total bilirubin, alkaline phosphatase, LDH, SGOT above the laboratory reference. Clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine above the laboratory reference.
•6\. Presence of active neoplastic disease.
•7\. Patients who have had electroconvulsive therapy within 90 days.
•8\. Patients with any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug.
•9\. Patients who are using drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone) within the previous
•4 weeks (or 5 half lives of inducing agent, whichever is longer) of enrollment in this study.