NCT02466074: perfuseMS

Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis

Terminated Phase 2 Results posted Last updated 27 April 2023

What this trial tests

Phase 2 trial testing Acetazolamide in Multiple Sclerosis in 5 participants. Terminated before completion.

Timeline

17 August 2016

Primary endpoint
7 February 2022

7 February 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	5
Start date	17 August 2016
Primary completion	7 February 2022
Estimated completion	7 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Acetazolamide (ACETAZOLAMIDE) — full drug profile →
• Placebo

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Global Cerebral Blood Flow Primary · baseline, 24 weeks

Percent change in global cerebral blood flow (CBF) after 24 weeks relative to pre-treatment baseline. Global CBF is determined using magnetic resonance imaging (MRI) methods. The data reported indicate the extent of change in global CBF--the higher the percent change, the greater the increase in global CBF and the better the outcome.

Group	Value	95% CI
Acetazolamide	22.9	± 16.2

Percent Change in Tissue Integrity in White Matter (Mean Diffusivity) Secondary · baseline, 24 weeks

The data reported indicate the extent of change in white matter integrity as determined using the diffusion tensor imaging-magnetic resonance imaging (DTI-MRI) measure of mean diffusivity. A positive percent change value indicates an increase in mean diffusivity between baseline and 24 weeks, and a higher mean diffusivity value indicates a breakdown in white matter integrity, so the greater the percent change, the greater the breakdown of white matter integrity and the worse the outcome.

Group	Value	95% CI
Acetazolamide	1.9	± 1.3

Percent Change in Tissue Integrity in White Matter (Fractional Anisotropy) Secondary · baseline, 24 weeks

The data reported indicate the extent of change in white matter integrity as determined using the diffusion tensor imaging-magnetic resonance imaging (DTI-MRI) measure of fractional anisotropy. A negative percent change value indicates a decrease in fractional anisotropy between baseline and 24 weeks, and a lower fractional anisotropy value indicates a breakdown in white matter integrity, so the lower (and more negative) the percent change, the greater the breakdown of white matter integrity and the worse the outcome.

Group	Value	95% CI
Acetazolamide	-2.8	± 2.4

Sponsor's own description

This study will evaluate how improved cerebral blood flow affects the way in which newly formed MS lesions evolve and whether tissue repair is improved. Patients with multiple sclerosis (MS) will be treated with acetazolamide in daily divided doses and obtain MRI to determine how much and in which regions of the brain cerebral perfusion improves as well as the extent to which tissue integrity is improved in these areas.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A multilevel screening pipeline in zebrafish identifies therapeutic drugs for GAN.
   Lescouzères L, Hassen-Khodja C, Baudot A, Bordignon B, et al · · 2023 · cited 8× · PMID 37144692 · DOI 10.15252/emmm.202216267