A Pilot Study of Lithium in Progressive Multiple Sclerosis

NCT ID: NCT01259388

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed Description

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lithium Carbonate

Intervention Type: DRUG

Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lithium Carbonate

Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.

Intervention Type: DRUG

Other Intervention Names

Standard care (observation)

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R Rinker, MD

Role: PRINCIPAL_INVESTIGATOR

Birmingham VA Medical Center, Birmingham, AL

Locations

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

Kirklin Clinic

Birmingham, Alabama, United States

Countries

United States

References

Rinker JR 2nd, Meador WR, King P. Randomized feasibility trial to assess tolerance and clinical effects of lithium in progressive multiple sclerosis. Heliyon. 2020 Jul 28;6(7):e04528. doi: 10.1016/j.heliyon.2020.e04528. eCollection 2020 Jul.

Reference Type: DERIVED

PMID: 32760832 (View on PubMed)

Other Identifiers

CDA2-003-10S

Identifier Type: -

Identifier Source: org_study_id