Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis Lithium
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: no

Brief 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.

Detailed 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).

Arms:
arm 1: 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. arm 2: 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).

Interventions: intervention 1: Lithium Carbonate
Intervention descriptions: intervention 1: Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

Protocol document: