Adenosine 2A Receptor Antagonism and AIH in ALS

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 21, 2022

Primary Completion Date

February 1, 2026

Study Completion Date

May 31, 2026

Conditions
ALS
Interventions
DRUG

Consume 20mg of istradefylline

Consume a single 20 mg istradefylline tablet

OTHER

Low Oxygen therapy

Breathing short periods of low oxygen, consisting of 15 episodes of 1 minute of breathing 10% oxygen, with 2 minutes of breathing 21% oxygen. 45 minutes total.

DRUG

Placebo counterpart to the istradefylline drug

Consume a single microcrystalline cellulose

OTHER

SHAM counterpart to low oxygen therapy.

Breathing short periods of sham low oxygen, consisting of 15 episodes of 1 minute of breathing 21% oxygen, separated by 2 minutes of breathing 21% oxygen. 45 minutes total.

Trial Locations (2)

32209

RECRUITING

UF Health Jacksonville, Jacksonville

32610

RECRUITING

Clinical and Translational Research Building, Gainesville

All Listed Sponsors
collaborator

ALS Association

OTHER

lead

University of Florida

OTHER