A Pilot Study of Lithium in Progressive Multiple Sclerosis
Status: | Completed |
---|---|
Conditions: | Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 30 - 65 |
Updated: | 4/21/2016 |
Start Date: | May 2011 |
End Date: | December 2015 |
A Pilot Trial of Lithium in Progressive Multiple Sclerosis
The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated,
and effective at treating progressive forms of multiple sclerosis.
and effective at treating progressive forms of multiple sclerosis.
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.
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