Clinical trials: Off Episodes of Parkinson Disease
Parkinson Disease (PD), Parkinson's Disease
Real-world Patient Experiences With Inbrija®
Parkinson's disease can cause OFF episodes, when medication effects wear off and symptoms return, affecting movement, daily activities, comfort, and wellbeing.
- Conditions
- Parkinson Disease (PD), Parkinson's Disease, Off Episodes of Parkinson Disease
- Trial name
- INHALE-PD (NCT07797790)
- Testing
- Levodopa inhalation powder
- Where
- 2 sites in Austria
- Volunteers
- 120 people
- Sponsor
- Merz Therapeutics GmbH
Parkinson Disease
Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes
This study will be conducted with In-clinic visits and treatment at home for each patient with established Parkinson's disease (PD) experiencing daily OFF episodes.
- Trial name
- NCT05979415
- Testing
- Apomorphine Cartridge
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Alexza Pharmaceuticals, Inc.
Parkinson Disease
Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months
The objective of this study was to measure the continued efficacy of apomorphine after previous exposure of at least three months duration.
- Trial name
- NCT00200512
- Testing
- apomorphine HCl injection
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Mylan Bertek Pharmaceuticals
Idiopathic Parkinson's Disease
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an…
- Trial name
- SPAN-PD™ (NCT02240030)
- Testing
- CVT-301 Low Dose, CVT-301 High Dose
- Where
- 74 sites in United States, Canada and 3 more
- Volunteers
- 351 people
- Sponsor
- Acorda Therapeutics
Idiopathic Parkinson's Disease
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor…
- Trial name
- NCT02352363
- Testing
- CVT-301, Observational cohort
- Where
- 76 sites in United States, Austria and 12 more
- Volunteers
- 408 people
- Sponsor
- Acorda Therapeutics
Parkinson Disease, Off Episodes
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and…
- Trial name
- NCT02469090
- Testing
- APL-130277
- Where
- 33 sites in United States, Canada
- Volunteers
- 141 people
- Sponsor
- Sumitomo Pharma America, Inc.
Parkinson Disease
Long Term Safety and Efficacy of SC Apomorphine in Treatment of "Off" Episodes in Late-Stage Parkinson's Disease
The current protocol is designed to satisfy the need for a compassionate use treatment protocol as well as for a long-term open label follow-up study.
- Trial name
- NCT00142545
- Testing
- apomorphine HCl injection
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- Mylan Bertek Pharmaceuticals
Motor OFF Episodes Associated With Parkinson's Disease
A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes) compared to an approved drug used to treat people with Parkinson's Disease…
- Trial name
- NCT03391882
- Testing
- APL-130277, subcutaneous apomorphine
- Where
- 31 sites in Austria, France and 4 more
- Volunteers
- 113 people
- Sponsor
- Sumitomo Pharma America, Inc.
Usability
Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients
Currently there is one Levodopa inhaler on the market, the INBRIJA® inhaler. When looking at the user instructions for the INBRIJA®, multiple steps are necessary including preparing and cleaning the inhaler.
- Trial name
- DPI-6 (NCT05499572)
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Martini Hospital Groningen
Parkinson Disease
Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease
Study to measure the continued effectiveness of apomorphine after previous exposure of at least three months duration.
- Trial name
- NCT00200525
- Testing
- apomorphine HCl injection
- Volunteers
- 60 people
- Sponsor
- Mylan Bertek Pharmaceuticals
Idiopathic Parkinson's Disease
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.
- Trial name
- NCT01617135
- Testing
- CVT-301, Sinemet (carbidopa/levodopa)
- Where
- 7 sites in Israel, Serbia and 1 more
- Volunteers
- 25 people
- Sponsor
- Acorda Therapeutics
Idiopathic Parkinson's Disease
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an…
- Trial name
- NCT01777555
- Testing
- CVT-301
- Where
- 22 sites in United States, Italy and 2 more
- Volunteers
- 89 people
- Sponsor
- Acorda Therapeutics
Parkinson Disease
The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes
The study is being conducted to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of XJN010 Nasal Spray in Patients with Parkinson's Disease Experiencing Off Episodes
- Trial name
- NCT07156773
- Testing
- XJN010 Nasal Spray
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Guangzhou Novaken Pharm Co., Ltd.
Parkinson's Disease
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii.
- Trial name
- NCT00489255
- Testing
- Tigan®
- Where
- 27 sites in United States
- Volunteers
- 117 people
- Sponsor
- Ipsen
Parkinson's Disease, Off Episodes of Parkinson Disease
A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes
A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
- Trial name
- NCT03187301
- Testing
- APL-130277, Moxifloxacin
- Where
- 15 sites in United States, Italy
- Volunteers
- 48 people
- Sponsor
- Sumitomo Pharma America, Inc.
Parkinson, Parkinson Disease
A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops® Relative to INBRIJA®
Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular…
- Conditions
- Parkinson, Parkinson Disease, Parkinson's Disease and Parkinsonism
- Trial name
- NCT06037590
- Testing
- Levodopa Cyclops®, INBRIJA®
- Where
- Bulgaria
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- PureIMS B.V.
Parkinson Disease
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
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…
- Trial name
- NCT03292016
- Testing
- APL-130277, APO-go, Apokyn
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Sumitomo Pharma America, Inc.
Idiopathic Parkinson's Disease
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes).
- Trial name
- NCT02242487
- Testing
- CVT-301
- Where
- 74 sites in United States, Canada and 3 more
- Volunteers
- 325 people
- Sponsor
- Acorda Therapeutics
Parkinson Disease
Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
- Trial name
- NCT02542696
- Testing
- APL-130277
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 496 people
- Sponsor
- Sumitomo Pharma America, Inc.