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Istradefylline for Parkinson's Disease Tremor
Phase 4
Waitlist Available
Led By Fernando Pagan
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study subjects are willing to present for all study visits and take medication
Clinical diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial studies the effects of a novel Parkinson's drug in 25 patients to improve motor symptoms. Patients will be monitored before and after treatment.
Who is the study for?
This trial is for Parkinson's disease patients who experience tremors and are on a stable dose of their current medications, including carbidopa-levodopa. They must understand the study, be able to consent, have a MOCA score of at least 22, and commit to all study visits. Excluded are those with severe heart issues, dementia, Parkinson's plus syndromes, significant dyskinesia or psychosis concerns.Check my eligibility
What is being tested?
The trial tests Istradefylline pills as an additional treatment for managing motor symptoms in Parkinson's disease over six months. It will involve 25 patients whose symptoms aren't fully controlled by existing medication doses. Their motor functions will be evaluated before and after adding Istradefylline.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common ones associated with Istradefylline may include nausea, dizziness or lightheadedness when standing up quickly (orthostatic hypotension), sleep disturbances like insomnia or excessive daytime sleepiness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to attend all study visits and take medication as required.
Select...
I have been diagnosed with Parkinson's disease.
Select...
I have been on a stable dose of my current medications, including carbidopa-levodopa, for at least 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To observe the effect of Istradefylline on tremor in PD patients.
Secondary outcome measures
To assess changes in motor impairment using the Right Eye eye- tracking technology.
To assess the utility of a tremor capturing application such as Mindsquare app.
To evaluate the changes in MDS-UPDRS II motor symptoms in PD patients with tremor.
+4 moreSide effects data
From 2016 Phase 3 trial • 613 Patients • NCT0196803116%
Dyskinesia
9%
Fall
6%
Nausea
4%
Constipation
4%
Dizziness
4%
Fatigue
3%
Urinary tract infection
3%
Vomiting
3%
Insomnia
3%
On and off phenomenon
2%
Diarrhoea
2%
Paraesthesia
2%
Contusion
2%
Gait disturbance
2%
Influenza
2%
Hypertension
2%
Somnolence
2%
Arthralgia
2%
Hallucination
2%
Anxiety
2%
Abnormal dreams
2%
Headache
1%
Cough
1%
Disturbance in attention
1%
Depression
1%
Vision blurred
1%
Asthenia
1%
Blood creatinine increased
1%
Myalgia
1%
Back pain
1%
Akinesia
1%
Hot flush
1%
Anaemia
1%
Orthostatic hypotension
1%
Vertigo
1%
Sinusitis
1%
Head injury
1%
Blood pressure increased
1%
Blood uric acid increased
1%
Neck pain
1%
Presyncope
1%
Rib fracture
1%
Excoriation
1%
Tinnitus
1%
Weight decreased
1%
Amylase increased
1%
Abdominal distension
1%
Dental caries
1%
Abdominal pain upper
1%
Oedema peripheral
1%
Rhinitis
1%
Nasopharyngitis
1%
Upper respiratory tract infection
1%
Bronchitis
1%
Cystitis
1%
Road traffic accident
1%
Eosinophil count increased
1%
Blood creatine phosphokinase increased
1%
Pain in extremity
1%
Musculoskeletal pain
1%
Muscle spasms
1%
Restless legs syndrome
1%
Parkinson's disease
1%
Micturition urgency
1%
Rash
1%
Freezing phenomenon
1%
Dystonia
1%
Leukopenia
1%
Tremor
1%
Rapid eye movements sleep abnormal
1%
Lipase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Istradefylline 40 mg/Day
Placebo
Istradefylline 20 mg/Day
Trial Design
1Treatment groups
Experimental Treatment
Group I: Istradefylline 20 and 40 mgExperimental Treatment1 Intervention
The study intervention will be to add 20 mg Istradefylline for 2 weeks, following which the dose will be increased to 40 mg daily for the remainder of the 24 weeks.
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,475 Total Patients Enrolled
Kyowa Kirin, Inc.Industry Sponsor
47 Previous Clinical Trials
5,694 Total Patients Enrolled
Fernando PaganPrincipal InvestigatorGeorgetown University Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication that strongly affects liver enzyme activity.I am willing to attend all study visits and take medication as required.You scored 22 or higher on the MOCA test.I experience frequent or severe involuntary movements.I have been diagnosed with dementia, affecting my daily life.We will use a test to measure how much you shake before starting the study.I do not have psychosis or symptoms that would make IST unsafe for me.I have been diagnosed with Parkinson's disease.I have been on a stable dose of my current medications, including carbidopa-levodopa, for at least 30 days.I currently have an active cancer.I am currently taking medication that strongly affects liver enzymes.I have a condition similar to Parkinson's but it's not idiopathic Parkinson's disease.I have severe heart disease or heart failure.I have severe dizziness or fainting when standing up.
Research Study Groups:
This trial has the following groups:- Group 1: Istradefylline 20 and 40 mg
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects, if any, may arise from taking Istradefylline 20 or 40 mg?
"With ample clinical data affirming its safety, Istradefylline 20 and 40 mg scored a 3 on the 1-3 scale. The drug is currently approved after undergoing Phase 4 trials."
Answered by AI
How many individuals have chosen to partake in this investigation?
"That is correct. According to the information hosted on clinicaltrials.gov, this research endeavour that was initially posted on January 20th 2021 is presently looking for 25 individuals across a single medical site. The study details were last modified on May 22nd 2021."
Answered by AI
Is this research endeavor actively seeking new participants?
"Affirmative. The clinicaltrial.gov page indicates that this medical trial, which was first listed on January 20th 2023, is currently enrolling participants. In total, 25 people are needed from 1 site to complete the study protocol."
Answered by AI
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