A Pilot Study of Lithium in Progressive Multiple Sclerosis
Completed · Phase 1/Phase 2
Conditions studied: Multiple Sclerosis
In brief
The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.
Key facts
- Study ID
- NCT01259388
- Run by
- VA Office of Research and Development
- People needed
- 23
- Starts
- 2011-05-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2019-09-10
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States
- Kirklin Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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