Status:
WITHDRAWN
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)
Lead Sponsor:
Clene Nanomedicine
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
REPAIR-ALS is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 ...
Detailed Description
This is a single-center open label pilot, sequential group, investigator blinded study of the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been...
Eligibility Criteria
Inclusion
- Able to understand and give written informed consent.
- Male or female patients aged 35 years or greater (inclusive) and less than 75 years of age at the time of ALS diagnosis.
- Patients with a confirmed ALS diagnosis: "definite ALS" or "probable ALS" or "possible" diagnostic criteria per the revised El Escorial Criteria as determined by a neurologist subspecializing in ALS (e.g., the Principal Investigator by study site).
- Stable background therapy (e.g., stable dosing of riluzole within the prior 6-weeks) per Investigator discretion.
- At the time of Screening disease duration less than or equal to 24-months from symptom onset OR within 12-moths of a confirmed ALS diagnosis.
- Forced vital capacity (FVC) \>/= 60% of predicted value as adjusted for gender, height, and age at the Screening Visit.
- Patients who are ambulatory (e.g., normal ambulation, early ambulation difficulties, or walks with assistance) on the ALSFRS-R scale.
Exclusion
- At Screening patients who utilize, or in the Investigator's judgment will be imminently dependent upon during the course of this study:
- Non-invasive ventilation
- Gastrostomy (e.g., use of percutaneous endoscopic gastrostomy tube)
- Use of wheel chair
- Patient who have previously undergone tracheostomy.
- Patient with a history of significant other major medical condition based on the Investigator's judgment.
- Based on the investigator's judgment, patients who may have difficulty complying with the protocol and/or study procedures.
- Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with study participation.
- Patient participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter)
- Females who are pregnant or nursing or who plan to get pregnant during the course of this clinical trial or within 6 months of the end of this trial.
- Positive screen for drugs of abuse or known alcohol abuse.
- Women of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control during the study or for 6 months following completion of study participation.
- Women with a positive pregnancy test, are lactating, or are planning to become pregnant during the study.
- Patients with implanted metal objects in their body that may be affected by an MRI procedure.
- Patients who are claustrophobic or otherwise unlikely to be able to complete the MRI scanning procedures.
- Patients with a history of gold allergy.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03843710
Start Date
March 1 2020
End Date
March 1 2022
Last Update
April 3 2023
Active Locations (1)
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1
UT Southwestern
Dallas, Texas, United States, 75390