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Istradefylline for Parkinson's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Virginia Commonwealth University, Richmond, VAParkinson's Disease+1 MoreIstradefylline - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether istradefylline can improve cognition in people with Parkinson's disease who also have cognitive impairment.

Eligible Conditions
  • Parkinson's Disease
  • Cognitive Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Baseline to 26 weeks

Baseline to 26 weeks
Change in Parkinson disease stage
Change in Parkinson's health status
Change in Schwab and England ADL score
Change in clinical symptoms related to Parkinson disease
Change in cognitive status
Change in executive function - Card Sort test
Change in executive function - Trail Making Test
Change in higher cortical functions
Change in hours of "off" time
Change in hours of "on" time
Change in neurocognitive outcomes
Change in oral fluency
Change in percentage of "off" time
Change in percentage of "on" time
Change in recall
Change in severity of illness

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Pramipexole
2
Dipraglurant
2
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Side Effects for

Istradefylline 20 mg/Day
11%Dyskinesia
6%Fall
5%Insomnia
4%Nausea
4%Nasopharyngitis
3%Paraesthesia
3%Dizziness
3%Urinary tract infection
3%Orthostatic hypotension
2%Contusion
2%Somnolence
2%Arthralgia
2%Excoriation
2%Headache
2%Influenza
1%Hyponatraemia
1%Erythema
1%Anaemia
1%Fatigue
1%Leukopenia
1%Vomiting
1%Constipation
1%Oedema peripheral
1%Blood uric acid increased
1%Hyperkalaemia
1%Neck pain
1%Parkinson's disease
1%Amylase increased
1%Pyrexia
1%Bradykinesia
1%Balance disorder
1%Gastrooesophageal reflux disease
1%Hyperlipidaemia
1%Tremor
1%Blood bilirubin increased
1%On and off phenomenon
1%Bronchitis
1%Anxiety
1%Tooth abscess
1%Upper respiratory tract infection
1%Weight decreased
1%Red blood cell count decreased
1%Lipase increased
1%Haematocrit decreased
1%Blood urea increased
1%Blood triglycerides increased
1%Blood creatine phosphokinase increased
1%Back pain
1%Pain in extremity
1%Sleep disorder
1%Restlessness
1%Hallucination, visual
1%Depression
1%Sinus congestion
1%Oropharyngeal pain
1%Nasal congestion
1%Dyspnoea
1%Cough
1%Hypotension
1%Hot flush
1%Blood pressure fluctuation
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT01968031) in the Istradefylline 20 mg/Day ARM group. Side effects include: Dyskinesia with 11%, Fall with 6%, Insomnia with 5%, Nausea with 4%, Nasopharyngitis with 4%.

Trial Design

1 Treatment Group

Usual care plus istradefylline
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Istradefylline · No Placebo Group · Phase 2

Usual care plus istradefylline
Drug
Experimental Group · 1 Intervention: Istradefylline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Istradefylline
2014
Completed Phase 3
~1120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 26 weeks

Who is running the clinical trial?

Kyowa Kirin, Inc.Industry Sponsor
35 Previous Clinical Trials
5,311 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
631 Previous Clinical Trials
367,527 Total Patients Enrolled
Matthew Barrett, MDPrincipal InvestigatorVirginia Commonwealth University

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You should not have Parkinson's disease at a severe stage (less than stage 4) during the "on" state.
You are currently taking carbidopa/levodopa medication.
You have symptoms of memory loss or trouble thinking that may be related to Parkinson's disease.
References

Frequently Asked Questions

How many individuals have been enlisted for this experiment?

"That is correct. Clinicaltrials.gov suggests that this medical experiment, which was first listed on July 18th 2022, is presently enrolling patients and required 10 participants from 1 particular location." - Anonymous Online Contributor

Unverified Answer

What potential risks does Istradefylline pose to those who take it?

"Istradefylline's safety rating is 2, as there is some evidence to suggest its safety but no information yet on how effective it may be." - Anonymous Online Contributor

Unverified Answer

Are there current opportunities for participants to join this medical experiment?

"Affirmative. The clinicaltrials.gov webpage reveals that this investigation is actively recruiting participants, having first been posted on 18 July 2022 and last updated on 10 August 2022. In total, they are looking to enrol 10 people at a single trial site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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