NCT02869360

Brief Summary

Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific. This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Typical duration 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

First Submitted

Initial submission to the registry

August 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

August 12, 2016

Last Update Submit

October 2, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Whole Brain PBR28 binding

    Baseline

Secondary Outcomes (4)

  • Lesional PiB binding

    Baseline

  • Myelin Water Imaging

    Baseline

  • MR Spectroscopy (Total NAA, NAA/Cr, mI)

    Baseline

  • Optical Coherence Tomography (RNFL thickness)

    Baseline

Study Arms (2)

Multiple Sclerosis (MS) patients

4 Secondary Progressive MS patients on no disease modifying therapy 4 Primary Progressive MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on Glatiramer Acetate 40 mg three times a week

Healthy Controls

4 Healthy volunteers aged between 18-60 years of age

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA 40mg TIW

You may qualify if:

  • Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
  • Aged 18 to 60
  • High or mixed affinity binder to rs6971 TSPO polymorphism

You may not qualify if:

  • Pregnant or breastfeeding
  • Suffering from an unstable medical condition
  • Have a neurological or ocular disorder other than MS
  • Any contra-indications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MS Clinical Trials Group - UBC

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Fellow

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 16, 2016

Study Start

October 1, 2016

Primary Completion

October 2, 2019

Study Completion

October 2, 2019

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations

CA(1)