View Clinical Trial (Medical Research Study)
A Pilot Trial of Lithium in Progressive Multiple Sclerosis
| City: |
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Birmingham |
| State: |
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Alabama |
| Zip Code: |
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35233 |
| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated,
and effective at treating progressive forms of multiple sclerosis.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Diagnosis of a progressive subtype of multiple sclerosis by revised 2005 McDonald
Criteria.
2. EDSS of 3.0-6.5
3. Ages 30-65
4. Must be mentally capable of providing informed consent and following study
guidelines.
Exclusion Criteria:
1. Relapse or steroid treatment within 1 month of trial entry.
2. Any current or previous treatment with mitoxantrone, azathioprine, methotrexate,
mycophenolate, cyclophosphamide, or any experimental therapy.
3. Women who are pregnant, wishing to become pregnant in the coming 30 months, or are
breastfeeding.
4. Sexually active women unwilling to use reliable contraception (oral contraceptives,
condom, IUD).
5. 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.
6. Patients with a history of unstable psychiatric illness or active severe depression.
7. Patients with a history of seizure.
8. Concurrent use of any of the following medications: Antipsychotics, diuretics,
digoxin, or iodide salts.
9. Use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 or more days a week.
10. Patients with a history of substance abuse in the past year.
11. Patients sensitive to gadolinium, or who are unable to undergo the required number of
MRI scans.
12. Unable to speak or understand sufficient English to consent or complete study
procedures.
13. Patients unable or unwilling to provide informed consent.
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| NCT ID: |
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NCT01259388 |
| Primary Contact: |
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Principal Investigator
John R. Rinker, MD
VA Medical Center, Birmingham
John R Rinker, MD
Email: John.Rinker@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Birmingham, Alabama 35233
United States
John R Rinker, MD
Email: John.Rinker@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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