|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
8 March 2021 |
|
Main ID: |
NCT02525471 |
|
Date of registration:
|
12/08/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
October 2015 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02525471 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Sabrina Paganoni, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital |
|
|
Name:
|
Nazem Atassi, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed as having possible,
probable, probable-laboratory supported, or definite ALS, either sporadic or familial
according to modified El Escorial criteria.
- Age 18-80, able to provide informed consent, and comply with study procedures.
- Participants must not have taken riluzole for at least 30 days, or be on a stable dose
of riluzole for at least 30 days, prior to screening (riluzole-naïve participants are
permitted in the study).
- Women must not be able to become pregnant (e.g. post menopausal, surgically sterile,
or using adequate birth control) for the duration of the study and 3 months after
study completion.
- Males should practice contraception for the duration of the study and 3 months after
completion.
- Ability to safely lie flat for 90 min for Positron Emission Tomography (PET)
procedures in the opinion of the study physician.
- High or mixed affinity to bind translocator (TSPO) protein (Ala/Ala or Ala/Thr)
Exclusion Criteria:
- Abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine
transaminase (ALT) > 3 times the upper limit of the normal.
- Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of
normal.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the participant to provide informed consent, according to PI
judgment.
- Clinically significant unstable medical condition (other than ALS) that would pose a
risk to the participant if they were to participate in the study.
- History of HIV, clinically significant chronic hepatitis, or other active infection.
- Females must not be lactating or pregnant.
- Active participation in another ALS clinical trial within 30 days of the Screening
Visit
- Exposure to immunomodulatory medications within 30 days of the Screening Visit.
- Any contraindication to undergo MRI studies such as
- History of a cardiac pacemaker or pacemaker wires
- Metallic particles in the body
- Vascular clips in the head
- Prosthetic heart valves
- Claustrophobia
- Radiation exposure that exceeds the site's current guidelines
- Current use of tobacco products including cigarettes, cigars, snuff and chewing
tobacco, or nicotine replacement products such as gum or patch
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
ALS
|
|
Intervention(s)
|
|
Drug: RNS60
|
|
Primary Outcome(s)
|
|
Clinical Outcome: Change in Pulmonary Function From Baseline to Week 23, Measured by Slow Vital Capacity (SVC)
[Time Frame: 24 Weeks]
|
|
Change From Baseline in Standardized Uptake Value (SUV) Normalized to Whole Brain Mean (SUVR) at Approximately 60-90 Minutes Post Injection
[Time Frame: 24 Weeks]
|
|
Clinical Outcome: Change in Functional Status Between Baseline and Week 23, Measured by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
[Time Frame: 24 Weeks]
|
|
Tolerability to Complete the Entire 24 Week Study on Study Drug
[Time Frame: 24 weeks]
|
|
Blood Biomarkers of Inflammation.
[Time Frame: 24 Weeks]
|
|
Clinical Outcome: Change in Strength From Baseline to Week 23, Measured by Accurate Test of Limb Isometric Strength (ATLIS)
[Time Frame: 24 Weeks]
|
|
Safety as Measured by the Number of Participants Experiencing Adverse Events
[Time Frame: 28 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|