None listed
Conditions
Brief summary
This pilot safety clinical trial proposes an amended shortened version of the apomorphine pen initiation for patients with no prior history of PD medication induced nausea. This streamlined approach has the potential to significantly improve the initiation process for PD patients, making it quicker without compromising safety. The initial dose will be in line with current recommendations of 2mg (0.2mL) without the presence of an antinausea medication. The dose will be slowly titrated as required until the optimum dosage has been reached. This study will provide valuable insights and pave the way for protocol adjustments that benefit both patients and healthcare providers.
Interventions
This study removes potentially unnecessary steps identified in the current initiation recommendations approved by the Therapeutics Good Administration for the commencement of Apomorphine injections therapy in people with Parkinson's disease (PD). People with PD who experience no nausea with current PD medications and experience significant OFF periods will be injected subcutaneously by our advanced care nurse, with a test dose of 2mg of Apomorphine and assessed for any adverse side effects. Slow
This study removes potentially unnecessary steps identified in the current initiation recommendations approved by the Therapeutics Good Administration for the commencement of Apomorphine injections therapy in people with Parkinson's disease (PD). People with PD who experience no nausea with current PD medications and experience significant OFF periods will be injected subcutaneously by our advanced care nurse, with a test dose of 2mg of Apomorphine and assessed for any adverse side effects. Slow, individualized up-titration monitored by our advanced care nurse to optimize tolerability and minimize adverse effects will be done weekly via telehealth. Each participant will document their apomorphine response in a recording table along with any adverse events, which will be reviewed at each telehealth appointment to determine if an increase in dose is required until peak response is reached within one month of commencement. The maximum dose during the up-titration process will be 5mg. The number of injections administered is recorded in the response recording table and is dependent on the number of OFF periods experienced by each individual. The injections are used to treat refractory OFF periods when oral medications are not working traditionally. A minimum of one hour between apomorphine doses is required and no more than 5 doses within a 24-hour period. Peak response is defined as turning the person to "ON" state within 12 minutes with the effect lasting at least 45 minutes. Once the therapeutic dosage has been found that dose remains unchanged indefinitely while experiencing OFF periods. This study will review patients 12 months after the commencement of apomorphine to determine the on-going effect of the treatment.
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults with idiopathic PD. 2. Patients on an optimally maximized oral anti-PD medication for at least 30 days. 3. Experience at least one OFF medication period daily that is not amenable to oral therapy changes. 4. No other neurological condition that may affect their ability to follow instructions. 5. Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use highly effective and reliable contraception throughout the study and for at least 12 weeks after the last dose of apomorphine has been taken.
Exclusion criteria
1. History of nausea with PD medication and/or a predisposition to nausea and vomiting. 2. Atypical parkinsonism. 3. Known hypersensitivity or allergy to apomorphine, morphine, or other sodium metabisulphites (sulphur). 4. Known neuropsychiatric condition or hallucinations. 5. Diagnosed dementia. 6. Patients with unstable and clinically significant orthostatic hypotension. 7. High risk cardiac history including prolonged QTc and arrhythmias, cardiac decompensation and cerebrovascular disease. 8. Currently lactating or pregnant or planning to become pregnant during the study.
Outcome results
None listed