DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Pilot Study of Lithium in Progressive Multiple Sclerosis

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Lithium Carbonate (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
John R. Rinker, MD, Principal Investigator, Affiliation: Birmingham VA Medical Center, Birmingham, AL

Summary

The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.

Clinical Details

Official title: A Pilot Trial of Lithium in Progressive Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of change in brain parenchymal fraction

Secondary outcome:

Number of new gadolinium-enhancing brain MRI lesions

Number and volume of new T2-weighted brain MRI lesions

Number and volume of new T1-weighted hypointense brain MRI lesions

Eligibility

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama 35233, United States

Kirklin Clinic, Birmingham, Alabama 35233, United States

Additional Information

Starting date: May 2011
Last updated: March 26, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017