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Amyotrophic Lateral Sclerosis or Frontotemporal Dementia

Amyotrophic Lateral Sclerosis or Frontotemporal Dementia

About this clinical trial

Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD) are rare and debilitating neurodegenerative diseases that have no known cure. The purpose of this trial is to determine if WVE-004 is safe and well tolerated in the the treatment of ALS and FTD when compared to a placebo control. WVE-004 could possibly be used a treatment option to decrease neurodegenerative symptoms in patients.    

Patients Required

Estimated completion

October 2023

Total participants required

2

Study location

The Wesley Hospital

Trial title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD).

Eligibility

ALS-Specific Inclusion Criteria:

  1. Diagnosis of ALS based on clinical manifestations.
  2. Clinically diagnosed possible; laboratory-supported probable; probable; or definite criteria for diagnosing ALS according to the World Federation of Neurology revised El Escorial criteria.

FTD-Specific Inclusion Criteria:

  1. Must have Global Clinical Dementia Rating score of 0.5 or 1.
  2. Able to undergo periodic magnetic resonance imaging (MRI).

Mixed (ALS and FTD) Inclusion Criteria:

  1. Must meet both ALS & FTD criteria as above.

Additional information

You can find out more about the WVE-004 trial by visiting the ClinicalTrials.gov website.

Lead investigator

Dr Robert Henderson

If you would like more information about this clinical trial, please complete the Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD) contact form

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Wesley Medical Research

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