A Pilot Trial of Lithium in Progressive Multiple Sclerosis
概览
- 阶段
- 1 期
- 干预措施
- Lithium Carbonate
- 疾病 / 适应症
- Multiple Sclerosis
- 发起方
- VA Office of Research and Development
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Rate of Change in Brain Parenchymal Fraction
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.
详细描述
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).
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lithium
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.
干预措施: Lithium Carbonate
结局指标
主要结局
Rate of Change in Brain Parenchymal Fraction
时间窗: 2 years
Paired comparison of change in brain parenchymal fraction during Lithium treatment and during observation period
次要结局
- Total Relapses(2 years)
- Change in Expanded Disability Status Scale Score(2 years)