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Lithium Treatment for Patients With Spinocerebellar Ataxia Type I

NCT00683943 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-12-17

No results posted yet for this study

Summary

This study will evaluate the side effects and tolerability of the drug lithium in patients with spinocerebellar ataxia type I (SCA1) an inherited disorder caused by loss of nerve cells in parts of the brain. Symptoms include ataxia (difficulty walking) and loss of muscle coordination and strength. Recent studies suggest that lithium may be helpful in treating some SCA1 symptoms.

People between 18 and 65 years of age with SCA1 who have only difficulty walking or who have difficulty walking as well as tremor, hand incoordination or speech problems, may be eligible for this study. Participation requires three hospital admissions at the NIH Clinical Center and one outpatient visit.

Participants undergo the following tests and procedures:

Admission 1 (2-6 weeks)

* Medical history, physical examination, blood and urine tests, electrocardiogram.
* Evaluation of SCA1 symptoms (balance, walking, dexterity, tremor, memory, mood and concentration).
* Monitoring of liquid intake and output (urine) and weight changes.
* Lithium treatment Start treatment and remain in hospital until the blood level of the drug is stabilized; continue treatment at home after hospital discharge.

Admission 2 (2-4 days, 4 weeks after hospital discharge).

* Repeat of some or all of the procedures done at the first admission.
* Continue lithium in hospital and at home after discharge, with local physician checking laboratory values as needed.

Admission 3 (2-4 days, 8 weeks after Admission 2).

* Repeat of some or all of the procedures done at other admissions.
* Stop lithium.

Outpatient Visit (4 weeks after Admission 3)

* Evaluation of SCA1 symptoms.
* Blood and urine tests.

Conditions

  • Spinocerebellar Ataxia Type I

Interventions

DRUG

Lithium Carbonate

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Grisel J Lopez, M.D. · National Human Genome Research Institute (NHGRI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-18
Primary Completion
2010-02-25
Completion
2010-02-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683943 on ClinicalTrials.gov