A Pilot Study of Lithium in Progressive Multiple Sclerosis

VA Office of Research and Development

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: Lithium Carbonate

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01259388

CDA2-003-10S

Details and patient eligibility

About

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

Full description

In progressive multiple sclerosis (MS), patients experience worsening disability through a combination of inflammatory and neuro-degenerative processes. To test whether low-dose lithium carbonate ameliorates disability accumulation in progressive MS, patients with progressive MS were randomly assigned to take lithium in either the first or second year of a two-year trial. The trial was designed as a cross-over study to maximize exposure to lithium to for two reasons: 1) To increase the number of persons with MS exposed to lithium for purposes of assessing safety and tolerance; and 2) To increase the power to detect changes in the primary radiological outcome (change in brain volume) and also in secondary clinical outcomes (disability, mood, fatigue, cognition).

Enrollment: 23 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Lithium

Experimental group

Description:

Lithium-treatment phase Lithium Carbonate: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

Treatment:

Drug: Lithium Carbonate

Observation

No Intervention group

Description:

During observation subjects continue on their standard of care disease modifying agent (or no agent at all if judged not appropriate by the treating physician).