- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant, NN1213 / Novo Nordisk
Enrollment closed, Enrollment change, Trial completion date: Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (clinicaltrials.gov) - Nov 26, 2023 P3, N=134, Active, not recruiting, Using a flexible dose initiation and titration strategy, backed by a comprehensive support network such as the CEP, supports successful treatment initiation. Recruiting --> Active, not recruiting | N=192 --> 134 | Trial completion date: Jun 2025 --> Jan 2025
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Use of Real-World Data to Evaluate the Importance of Antiemetic Pretreatment for Apomorphine hydrochloride [APO, Apokyn (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_4147; All cause discontinuation within 90 days of initiation also remained largely constant across the 3-year evaluation period (26%, 23% and 23%, respectively) and did not differ by Tigan use [23% in both Tigan users and nonusers in 2021]. Conclusions Overall, our analysis demonstrates that PwP can successfully initiate apomorphine SC injection without antiemetic prophylaxis.
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Neurologists (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_3466; Conclusions Overall, our analysis demonstrates that PwP can successfully initiate apomorphine SC injection without antiemetic prophylaxis. The sample had n=96 physicians who had previously prescribed APOKYN
- |||||||||| apomorphine inhalational (AZ-009) / Ferrer International
Clinical, PK/PD data, Journal: A Randomized Trial Assessing the Safety, Pharmacokinetics, and Efficacy During Morning Off of AZ-009. (Pubmed Central) - Apr 20, 2022 On-demand treatment was also considered appropriate in patients whose OFF episodes do not interfere with daily activities but impact their lives in other ways (e.g., job performance, fear of leaving home). AZ-009 appears to be a rapid-acting and reasonably well-tolerated formulation for treating off periods.
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Journal: A deep eutectic-based, self-emulsifying subcutaneous depot system for apomorphine therapy in Parkinson's disease. (Pubmed Central) - Mar 17, 2022 In vivo pharmacokinetics studies in rats and pigs further confirmed the extended release and improvement over the clinical comparator Apokyn. In vivo pharmacokinetics, supported by a pharmacokinetic simulation, demonstrate that the deep eutectic formulation reported here allows the maintenance of the therapeutic drug concentration in plasma in humans with a dosing regimen of approximately three injections per week compared to the current clinical practice of three injections per day.
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (clinicaltrials.gov) - Oct 20, 2021 P3, N=192, Recruiting, In vivo pharmacokinetics, supported by a pharmacokinetic simulation, demonstrate that the deep eutectic formulation reported here allows the maintenance of the therapeutic drug concentration in plasma in humans with a dosing regimen of approximately three injections per week compared to the current clinical practice of three injections per day. Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant, NN1213 / Novo Nordisk
Enrollment closed, Trial completion date, Trial primary completion date: APOMORPHEE: Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease (clinicaltrials.gov) - Feb 10, 2021 P4, N=45, Active, not recruiting, Physicians may be overestimating the extent of “needle phobia.” Discussion of invasive therapies requiring injection is appropriate with most patients who have troublesome OFF time. Recruiting --> Active, not recruiting | Trial completion date: Oct 2018 --> May 2021 | Trial primary completion date: Oct 2018 --> Jan 2021
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (clinicaltrials.gov) - Oct 3, 2019 P3, N=192, Recruiting, Sponsorship: Sunovion Pharmaceuticals Inc. Trial completion date: Sep 2022 --> Sep 2024 | Trial primary completion date: Mar 2021 --> Mar 2023
- |||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL, Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Trial completion, Enrollment change: A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes (clinicaltrials.gov) - Apr 5, 2019 P2, N=8, Completed, Trial completion date: Sep 2022 --> Sep 2024 | Trial primary completion date: Mar 2021 --> Mar 2023 Recruiting --> Completed | N=12 --> 8
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (clinicaltrials.gov) - Nov 19, 2018 P3, N=192, Recruiting, Recruiting --> Completed | N=12 --> 8 Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Mar 2020 --> Mar 2021
- |||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL, Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Trial completion date, Trial primary completion date: A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes (clinicaltrials.gov) - Sep 5, 2018 P2, N=12, Recruiting, N=24 --> 0 Trial completion date: Aug 2018 --> Mar 2019 | Trial primary completion date: Aug 2018 --> Mar 2019
- |||||||||| Kynmobi (apomorphine sublingual film) / Sumitomo Pharma, Aquestive, BIAL, Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Trial completion date, Trial primary completion date: A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes (clinicaltrials.gov) - Apr 3, 2018 P2, N=12, Recruiting, Trial completion date: Aug 2018 --> Mar 2019 | Trial primary completion date: Aug 2018 --> Mar 2019 Trial completion date: Mar 2018 --> Jun 2018 | Trial primary completion date: Mar 2018 --> Jun 2018
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Enrollment open, Trial initiation date, Trial primary completion date: Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (clinicaltrials.gov) - Mar 13, 2017 P3, N=192, Recruiting, Trial primary completion date: Oct 2017 --> Mar 2018 Not yet recruiting --> Recruiting | Initiation date: Oct 2016 --> Mar 2017 | Trial primary completion date: Oct 2019 --> Mar 2020
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Enrollment closed, Enrollment change: PERFORM: Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN (clinicaltrials.gov) - Nov 22, 2016 P4, N=13, Active, not recruiting, Active, not recruiting --> Terminated; Subject enrollment is unsatisfactory Recruiting --> Active, not recruiting | N=100 --> 13
- |||||||||| Xadago (safinamide) / Meiji Seika, Eisai, Valeo Pharma, Zambon, Supernus Pharma
Trial completion: MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist (clinicaltrials.gov) - Jun 18, 2012 P3, N=679, Completed, Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Enrollment change: Safety/Efficacy of Tigan (clinicaltrials.gov) - Apr 29, 2012 P4, N=117, Completed, Active, not recruiting --> Completed N=180 --> 117
- |||||||||| Apokyn (apomorphine bolus injection) / Stada, Supernus Pharma, Aguettant
Trial completion: Safety/Efficacy of Tigan (clinicaltrials.gov) - Apr 29, 2012 P4, N=117, Completed, N=180 --> 117 Recruiting --> Completed
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