A Pilot Study of Lithium in Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Lithium Carbonate

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.