NCT02228915

Brief Summary

The purpose of this research study is to discover and quantitate the differences in post-translational modifications found in the Cu, Zn superoxide dismutase (SOD1) of patients with amyotrophic lateral sclerosis (ALS) as compared to healthy individuals. SOD1 is a known genetic cause of ALS. With certain mutations, SOD1 gains a toxic function which leads to motor neuron death.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2018

Completed
Last Updated

October 17, 2018

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

August 27, 2014

Last Update Submit

October 16, 2018

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

  • Post-translational modifications (PTMs) of Cu/Zn superoxide dismutase 1

    6 months

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

SALS patients SOD1 associated FALS patients Healthy control

You may qualify if:

  • SALS patients
  • SOD1 associated FALS patients
  • Healthy control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Neurology ALS clinic

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A portion of this sample will be stored for future use in study of ALS and how the critical protien affects the disease progression long term. This sample will be stored de-identified; therefore will not be linked to any identifying informaton about the subject. Sample will be stored at the UNC biophysics and Biochemistry lab indefinitely

Study Officials

  • Chafic Karam, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Nikolay V Dokholyan, PhD

    UNC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

August 1, 2014

Primary Completion

October 14, 2018

Study Completion

October 16, 2018

Last Updated

October 17, 2018

Record last verified: 2017-11

Locations

US(1)