Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2020-06-18

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Amyotrophic Lateral Sclerosis in a cross-over design

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DNL747 First, Placebo Second

Group Type EXPERIMENTAL

DNL747

Intervention Type DRUG

Repeating oral dose

Placebo

Intervention Type DRUG

Repeating oral dose

Placebo First, DNL747 Second

Group Type EXPERIMENTAL

DNL747

Intervention Type DRUG

Repeating oral dose

Placebo

Intervention Type DRUG

Repeating oral dose

Open-Label Extension

Conducted in the Netherlands only.

Group Type EXPERIMENTAL

DNL747

Intervention Type DRUG

Repeating oral dose

Interventions

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DNL747

Repeating oral dose

Intervention Type DRUG

Placebo

Repeating oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women of non-childbearing potential and men, aged 21-80 years
* Willingness and ability to complete all aspects of the study; participant should be capable of completing assessments either alone or with help of a caregiver
* Diagnosis of laboratory-supported probable, probable, or definite (sporadic or familial) ALS according to the El Escorial World Federation of Neurology revised research diagnostic criteria
* Less than 3 years since symptom onset
* Forced vital capacity (FVC) \>50% predicted measured within 30 days of screening
* If subject is taking approved ALS treatments (riluzole and/or edaravone), doses must be stable for ≥2 months prior to screening and subject is expected to stay on a stable regimen throughout the study

* Successful completion of both periods of the the double-blind, crossover part of the study
* Continued diagnosis of laboratory-supported probable, probable, or definite (sporadic or familial) ALS according to the El Escorial World Federation of Neurology revised research diagnostic criteria

Exclusion Criteria

* History of a clinically significant non-ALS neurologic disorder (other than frontal temporal lobe dementia), including, but not limited to, muscular dystrophy, spinal stenosis, peripheral neuropathy, inherited neuropathies, AD, Parkinson's disease, Lewy body dementia, vascular dementia, Huntington's disease, epilepsy, stroke, multiple sclerosis, brain tumor, or brain infection or abscess
* Unstable or poorly controlled comorbid disease process of any organ system currently requiring active treatment or likely to require treatment adjustment during the study

* Presence of laboratory abnormalities, physical examination findings, or AEs determined to be clinically significant by the investigator from the double-blind part of the study that have not resolved by the final follow-up visit as part of the double-blind study period
* New diagnosis of clinically significant neurological disorder (other than frontal temporal lobe dementia)

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No