Lithium Treatment for Patients With Spinocerebellar Ataxia Type I
Status:
Completed
Trial end date:
2010-02-25
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)