advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1 Level: LLT Classification code 10061536
Conditions
Interventions
Product Name: Rotigotine Nasal Spray
Product Code: ND1421
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Rotigotine hydrochloride
CAS Number: 125572-93-2
Concentration unit: mg/ml mil
Sponsors
Schwarz Biosciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent. 2. Subject is willing and able to comply with all trial requirements. 3. Subject is aged =30 years. 4. Subject has idiopathic Parkinson disease, of more than 3 years in duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of Parkinsonism. 5. The investigator must observe the subject in both the “on” and “off” state and determines that the subject is Hoehn and Yahr stage II -IV in both the “on” and “off” state. 6. Subject has a Mini Mental State Examination (MMSE) score of = 25. 7. Subject is expected to be on a stable dose of levodopa, either short-acting or sustained release (in combination with benserazide or carbidopa) for at least 28 days prior to baseline (Visit 2) of at least 300mg/day, administered in at least 3 intakes. 8. Subject experiences end-of-dose “off” episodes despite attempts to optimize levodopa regimen. 9. Subject has a UPDRS Part III in “off” state of at least 25 points. 10. If the subject is receiving a dopamine agonist, entacapone, an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase (MAO) - B inhibitor (eg, selegiline, rasagiline), or a N-methyl- D-aspartate (NMDA) -antagonist (eg, amantadine), he/she is expected to be on a stable dose for at least 28 days prior to baseline (Visit 2). 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: 1. Subject has previously participated in this trial or was assigned to treatment with rotigotine in a previous trial. 2. Subject has participated in another trial of an investigational drug (or a medical device) within the last 30 days or is currently participating in another trial of an investigational drug (or a medical device). 3. Subject has atypical Parkinson syndrome(s), symptomatic Parkinson syndrome(s) due to drugs (eg metoclopramide, flunarizine), metabolic neurogenetic disorders (eg, Wilson disease), encephalitis, cerebrovascular disease or neurodegenerative disease (eg progressive supranuclear palsy). 4. Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant. 5. Subject has dementia, active hallucinations or active or treated psychosis. If subjects has hallucinations, he/she may participate if hallucinations are treated, and no symptoms occurred during the last 28 days. 6. Subject is receiving therapy with any of the following drugs currently or has done so within 3 months prior to the hospital admission visit (Visit 2): MAO-A inhibitors (pargyline, phenelzine and tranylcypromine), tolcapone, budipine, reserpine or alpha-methyldopa. 7. Subject is currently receiving CNS active therapy (eg, sedatives, hypnotics, anti- depressants, anxiolytics, atypical neuroleptics), unless the dose has been stable for at least 28 days prior to Visit 2 and is likely to remain stable until end of Visit 3. 8. Subject has a current diagnosis of epilepsy, a history of seizures as an adult, a history of stroke or had a TIA within 1 year prior to Visit 1. 9. Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin > 2.0mg/dL or ALT and/or AST greater than 2 times the upper limit of the reference range at Visit 1). 10. Subject has clinically relevant renal dysfunction (serum creatinine > 2.0mg/dL [>178µmol/L] at Visit 1). 11. Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in the opinion of the investigator would put the subject at risk of clinically relevant arrhythmia) and/or myocardial infarction within 1 year prior to Visit 1. 12. Subject has a QTc interval of = 500ms at Visit 1 (the Bazett's correction must be used for the correction of the QT interval). 13. Subject has symptoms of rhinitis or local disease or irritation of the nasal mucosa at Visit 2 or Visit 3. 14. Subject has had intra-nasal treatment within 14 days prior to Visit 3. 15. Subject has a history of symptomatic orthostatic hypotension, or systolic blood pressure less than 105mmHg at trial entry. 16. Subject has a history of chronic alcohol or drug abuse within the last 6 months. 17. Subject has a known or suspected hypersensitivity to any component of the investigational product or other nasal spray products. 18. Subject is pregnant or nursing, or is of child bearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including a highly effective method of birth control and at least 1 barrier method) or (iii) not sexually abstinent or (iv) subject is not at least 2 years post-menopausal 19. Subject has any medical condition, psychiatric condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize or would compromise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess the tolerability and safety of rotigotine nasal spray in subjects with advanced-stage idiopathic Parkinson’s disease. ;Secondary Objective: The secondary objective is to assess the efficacy of rotigotine nasal spray.;Primary end point(s): • Adverse events, as reported spontaneously by the subject or observed by the investigator recorded during the trial. • Changes in blood pressure and heart rate (with special emphasis on potential orthostatic reactions), electrocardiograms, clinical laboratory values. • Changes in physical and neurological examination from Visit 2 to the Safety Follow- up Visit. • Proportion of subjects who complete the trial. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed