A Pilot Study of Lithium in Progressive Multiple Sclerosis

Condition(s) targeted: Multiple Sclerosis

Intervention: Lithium Carbonate (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
John R. Rinker, MD, Principal Investigator, Affiliation: Birmingham VA Medical Center, Birmingham, AL

The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.

Official title: A Pilot Trial of Lithium in Progressive Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of change in brain parenchymal fraction

Secondary outcome:

Number of new gadolinium-enhancing brain MRI lesions

Number and volume of new T2-weighted brain MRI lesions

Number and volume of new T1-weighted hypointense brain MRI lesions

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of a progressive subtype of multiple sclerosis by revised 2005 McDonald

Criteria.

- EDSS of 3. 0-6. 5

- Ages 30-65

- Must be mentally capable of providing informed consent and following study

guidelines. Exclusion Criteria:

- Relapse or steroid treatment within 1 month of trial entry.

- Any current or previous treatment with mitoxantrone, azathioprine, methotrexate,

mycophenolate, cyclophosphamide, or any experimental therapy.

- Women who are pregnant, wishing to become pregnant in the coming 30 months, or are

breastfeeding.

- Sexually active women unwilling to use reliable contraception (oral contraceptives,

condom, IUD).

- Patients with known kidney dysfunction or creatinine >1. 4; known cardiac arrhythmia

or significant conduction abnormality on EKG; uncontrolled thyroid disease or TSH >20% above the upper limit of normal; uncontrolled psoriasis, HIV, or any other severe medical condition.

- Patients with a history of unstable psychiatric illness or active severe depression.

- Patients with a history of seizure.

- Concurrent use of any of the following medications: Antipsychotics, diuretics,

digoxin, or iodide salts.

- Use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 or more days a week.

- Patients with a history of substance abuse in the past year.

- Patients sensitive to gadolinium, or who are unable to undergo the required number of

MRI scans.

- Unable to speak or understand sufficient English to consent or complete study

procedures.

- Patients unable or unwilling to provide informed consent.

Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama 35233, United States

Kirklin Clinic, Birmingham, Alabama 35233, United States

Starting date: May 2011
Last updated: March 26, 2015