Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT02466074
• Date of registration: 03/06/2015
• Prospective Registration: Yes
• Primary sponsor: The University of Texas Health Science Center, Houston
• Public title: Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis perfuseMS
• Scientific title: Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis
• Date of first enrolment: August 17, 2016
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02466074
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: John Lincoln, MD, PhD
• Affiliation: UTHealth

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of relapsing forms of multiple sclerosis using revised McDonald criteria

2. Stable on any FDA-approved disease-modifying therapy. The term "stable" implies that
the subject has not had change in therapy for any reason for the 6 months prior to
study entry.

3. Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive

4. Understood and signed written informed consent, obtained prior to the study subject
undergoing any study related procedure, including screening tests.

Exclusion Criteria:

1. Known hypersensitivity to sulfonamides or derivatives

2. Known history of renal or hepatic disease, cerebrovascular disease including stroke,
transient ischemic attack, myocardial infarction, angina or congestive heart failure.

3. Evidence to suggest hyponatremia or hypokalemia, marked kidney dysfunction defined as
creatinine greater than 2.0 mg/dL or liver disease dysfunction defined as aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) greater than three-fold upper
limit of normal (ULN).

4. Evidence to suggest suprarenal gland failure.

5. Evidence of hyperchloremic acidosis.

6. Initiation of new immunosuppressant treatment after the subject becomes
protocol-eligible (except for corticosteroids) or enrollment in a concurrent trial.

7. Prior treatment with mitoxantrone, natalizumab, methotrexate, cladribine
cyclophosphamide or other change in disease modifying therapy (DMT) within 6 months of
initiation of study.

8. Subjects with any history of cytopenia.

9. History of pulmonary obstruction or emphysema.

10. Active hepatitis B or hepatitis C infection or evidence of cirrhosis.

11. Human immunodeficiency virus (HIV) positivity.

12. Uncontrolled diabetes mellitus defined as HbA1c>8% and/or requiring intensive
management.

13. Uncontrolled viral, fungal, or bacterial infection (excluding asymptomatic
bacteriuria).

14. Any condition that, in the opinion of the investigators, would jeopardize the ability
of the subject to tolerate treatment with ACZ.

15. Prior history of malignancy.

16. Positive pregnancy test or inability or unwillingness to use effective means of birth
control. Effective birth control defines as:

- Refraining from all acts of vaginal intercourse (abstinence)

- Consistent use of birth control pills

- Tubal sterilization or male partner who has undergone vasectomy

- Placement of an intrauterine device (IUD)

- Use, with every act of intercourse, of a diaphragm with contraceptive jelly
and/or condoms with contraceptive foam

17. Presence of metallic objects implanted in the body that would preclude the ability of
the subject to safely have MRI exams.

18. Psychiatric illness, mental deficiency, or cognitive dysfunction making compliance
with treatment of informed consent impossible.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Acetazolamide

Drug: Placebo

Primary Outcome(s)

Change in global cerebral blood flow with intervention [Time Frame: 24 weeks and at 48 weeks]

Secondary Outcome(s)

Change in tissue integrity in areas with and without increased cerebral blood flow with intervention [Time Frame: 24 weeks and at 48 weeks]

Composite changes in disability measures after acetazolamide (ACZ) compared to baseline [Time Frame: 1 year]

Secondary ID(s)

HSC-MS-14-0450

Source(s) of Monetary Support

Please refer to primary and secondary sponsors