Voxelotor Neurocognitive Function Study

PHASE3TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

June 24, 2022

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Sickle Cell Disease
Interventions
DRUG

Voxelotor Only Product in Oral Dose Form

During the Randomized Treatment Period, participants will be randomized in a 1:1 ratio to receive 1500 mg of voxelotor (or the weight-adjusted equivalent dose for participants \< 12 years old), once daily (administered orally as tablets/PFOS) or matching placebo for 12 weeks in addition to ongoing standard of care (SOC) treatment.

DRUG

Placebo

During the Randomized Treatment Period, participants will be randomized in a 1:1 ratio to receive 1500 mg of voxelotor (or the weight-adjusted equivalent dose for participants \< 12 years old), once daily (administered orally as tablets/PFOS) or matching placebo for 12 weeks in addition to ongoing standard of care (SOC) treatment.

Trial Locations (1)

21201

University of Maryland Medical Center, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT05228834 - Voxelotor Neurocognitive Function Study | Biotech Hunter | Biotech Hunter