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Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

NCT05683860•Wave Life Sciences Ltd.

View on ClinicalTrials.gov

Summary

This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult patients with ALS, FTD, or mixed ALS/FTD phenotype with a documented mutation in the C9orf72 gene. To participate in the study, patients must have successfully completed Phase 1b/2a WVE-004-001 study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient successfully completed the Phase 1b/2a study with WVE-004, WVE-004-001.

Exclusion Criteria

•Patient has a clinically significant medical finding on the physical examination other than C9orf72-associated ALS or FTD that, in the judgment of the Investigator or Sponsor, will make the patient unsuitable for participation in and/or completion of the trial procedures.
•Patient received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Patient received an investigational oligonucleotide within the past 6 months or 5 half-lives of the drug, whichever is longer.

Locations (3)

Erasmus MC

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

University of Oxford - Nuffield Department of Clinical Neurosciences

Oxford, United Kingdom

Key Dates

Start Date

December 14, 2022

Primary Completion Date

June 30, 2023

Completion Date

June 30, 2023

Last Updated

October 23, 2023

Enrollment

ACTUAL participants

Conditions

ALSFTD

Interventions

WVE-004

DRUG

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Healthy Adult ParticipantsToxic Chemicals+1 more

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RECRUITINGNA

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Cerebral Palsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)

Inclusion Criteria

Exclusion Criteria

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Effects of Play Based Neural Mobilisation Activities on Hand Grip Strength and Dexterity in Cerebral Palsy Children

Swiss Cerebral Palsy Registry