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Istradefylline and AIH for ALS
Study Summary
This trial will study whether istradefylline can improve or maintain breathing in people with ALS when used before AIH.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I currently have an active respiratory infection.I regularly take medications that affect liver enzymes or breathing.I have heart problems like irregular heartbeat or high blood pressure.My lung function is more than 60% of what is expected for someone my age and size.I have had moderate kidney problems or severe liver issues.I have been on a stable dose of riluzole and/or edaravone for over 30 days.My BMI is over 35.I have had hallucinations or psychosis in the past.I cannot safely swallow thin liquids.I have a condition that causes seizures.I need help breathing when awake or need extra oxygen.I have a history of low oxygen or high carbon dioxide levels in my blood.I have been diagnosed with a neurodegenerative disease.I am between 21 and 80 years old and do not smoke.My lung function is more than 60% of what is expected.I breathe very fast when resting.I use a daily inhaler for my lung condition.I have been diagnosed with ALS.I can swallow, speak, and breathe with minimal difficulty.
- Group 1: Sham-AIH + placebo (sham+CON)
- Group 2: AIH + placebo (AIH+CON)
- Group 3: Sham-AIH + istradefylline (sham+IST)
- Group 4: AIH + istradefylline (AIH+IST)
- 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
Is the research protocol still accepting new participants?
"Affirmative. The clinical trial is seeking 40 participants and, according to information on clinicialtrials.gov, it has been recruiting since June 21st 2022 with its last update occurring July 5th 2022."
What is the uppermost quantity of participants in this trial?
"Affirmative. Information on clinicaltrials.gov verifies that this experiment is still accepting participants, with 40 volunteers needed from a single medical site since its commencement date of June 21st 2022 and most recent update on July 5th 2022."
Is there an opportunity for me to participate in this medical experiment?
"This clinical trial seeks to recruit 40 non-smoking adults who are between 21 - 75 years old and living with amyotrophic lateral sclerosis. Prospective participants must meet the criteria detailed: El Escorial diagnostic classifications of probable/definite ALS, an ALS Functional Rating Scale (ALSFRS-R) score above 30, have been taking a stable dose of riluzole or edaravone for over 30 days, and have a vital capacity (VC) higher than 60% of their predicted value."
Does this medical study permit enrolment of individuals over the age of 70?
"As per the requirements for this medical trial, all participants must be between 21 and 75 years of age."
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