A Pilot Study of Lithium in Progressive Multiple Sclerosis
Ключавыя словы
Рэферат
Апісанне
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).
Даты
| Апошняя праверка: | 07/31/2019 |
| Упершыню прадстаўлена: | 12/09/2010 |
| Меркаваная колькасць заявак прадстаўлена: | 12/09/2010 |
| Першае паведамленне: | 12/13/2010 |
| Апошняе абнаўленне адпраўлена: | 08/20/2019 |
| Апошняе абнаўленне апублікавана: | 09/09/2019 |
| Дата першых прадстаўленых вынікаў: | 07/30/2019 |
| Дата першага прадстаўлення вынікаў кантролю якасці: | 08/20/2019 |
| Дата вынікаў першага размяшчэння: | 09/09/2019 |
| Фактычная дата пачатку даследавання: | 04/30/2011 |
| Разліковая дата першаснага завяршэння: | 07/31/2015 |
| Разліковая дата завяршэння даследавання: | 11/30/2015 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Drug: Lithium
Фаза
Групы ўзбраенняў
| Рука | Ўмяшанне / лячэнне |
|---|---|
| Experimental: 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. | Drug: Lithium Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time. |
| No Intervention: Observation 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). |
Крытэрыі прыдатнасці
| Узрост, які мае права на вучобу | 30 Years Каб 30 Years |
| Пол, прыдатны для навучання | All |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | 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. |
Вынік
Першасныя вынікі
1. Rate of Change in Brain Parenchymal Fraction [2 years]
Меры другаснага выніку
1. Total Relapses [2 years]
2. Change in Expanded Disability Status Scale Score [2 years]
