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Single dose reduced

Phase 1

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Biogen Inc.|Last Updated: Jun 22, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

Single dose reduced · 1 trial · 1 indication

Phase 1 1
NCT01424163Dexpramipexole Japanese PK StudyAmyotrophic Lateral Sclerosis
COMPLETED57 Analytics
PHASE1COMPLETED
Dexpramipexole Japanese PK Study
Amyotrophic Lateral Sclerosis
NCT0142416357
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Study Endpoints

Primary Endpoints

Cmax of dexpramipexole
pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.
AUC of dexpramipexole
pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.

Secondary Endpoints

Changes in clinical laboratory tests
pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
ECG changes
pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
Vital Sign changes
pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment 1 (Part A)EXPERIMENTALDexpramipexole single dose (reduced dose)
Treatment 2 (Part A)EXPERIMENTALDexpramipexole single dose (Standard dose)
Treatment 3 (Part A)EXPERIMENTALDexpramipexole multiple dosing
Treatment for Part BEXPERIMENTALDexpramipexole multiple dosing

Interventions

NameTypeDescription
Single dose reducedDRUGTreatment 1 (Part A)
Single dose standardDRUGTreatment 2 (Part A)
Multiple DoseDRUGTreatment 3 (Part A)
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who are able and willing to give written informed consent. * Adult Japanese and Caucasian males/females aged 18 to 60 years inclusive and between 18 and 30 kg/m2 body mass index (BMI), inclusive. * Male and female subjects will be enrolled on the study. Male subjects ...

Countries:United Kingdom
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Frequently asked questions about Single dose reduced

What is dexpramipexole used for?

Dexpramipexole is an investigational small molecule being studied for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being developed by Biogen Inc. (NASDAQ: BIIB).

Who is developing dexpramipexole?

Biogen Inc. (NASDAQ: BIIB) is developing dexpramipexole. The drug is an investigational small molecule in Phase 1 clinical development for amyotrophic lateral sclerosis (ALS). Biogen is conducting clinical trials to evaluate the safety and pharmacokinetics of dexpramipexole in healthy volunteers.

What phase is dexpramipexole in?

Dexpramipexole is in Phase 1 clinical development. It is an investigational drug for amyotrophic lateral sclerosis (ALS) and has not been approved by the FDA or other regulatory agencies. One Phase 1 study has been completed, and the drug remains under clinical investigation.

What clinical trials is dexpramipexole in?

Dexpramipexole has been studied in a completed Phase 1 clinical trial, NCT01424163, titled "Dexpramipexole Japanese PK Study." This trial enrolled 57 participants, including healthy volunteers, in the United Kingdom to evaluate the drug's pharmacokinetics. The study was controlled but not randomized or double-blinded.

Is dexpramipexole the same as other ALS drugs?

Dexpramipexole is a distinct investigational small molecule being developed by Biogen Inc. for amyotrophic lateral sclerosis (ALS). It is not the same as other marketed ALS treatments. The drug is in Phase 1 clinical development, and its safety and efficacy have not been established.