Effects of Lithium and Divalproex'on Brain-Derived Neurotrophic Factor in Huntington's Disease
Public ClinicalTrials.gov record NCT00095355. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Stimulation of Tyrosine Kinase and ERK Signaling Pathways in Huntington's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will examine whether lithium carbonate, given alone or with divalproex, increases the amount of brain-derived neurotrophic factor (BDNF) in the spinal fluid of patients with Huntington's disease (HD), a hereditary disorder of the central nervous system. Patients with this fatal degenerative disease have lower amounts of substances in the brain and spinal fluid called trophic or growth factors. One of these factors is BDNF. A possible treatment for HD may be to increase the levels of BDNF. Lithium carbonate, a drug used to treat bipolar disorder, and divalproex, a drug used to treat mood disorders and seizure disorders, have both been shown to increase the amount of BDNF protein in laboratory studies. Patients 18 to 70 years old with a DNA-confirmed diagnosis of Huntington's disease may be eligible for this study. Candidates are screened with a medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (EKG). Participants take lithium carbonate with and without divalproex. They also receive placebo (an inactive substance) for portions of the study. On the first day of the study, patients are given a supply of pills with instructions on how to take them. Blood pressure and pulse are measured, and blood and urine tests may be done. Patients are evaluated with standardized tests and scales for assessment of various aspects of HD. Patients return to the clinic once a week for follow-up evaluations, including blood and urine tests, physical examinations, disease assessments, and a review of medication side effects. Each week, they receive a new supply of medications and instructions on how to take them. At the end of the sixth week, they finish taking the medications. During the study, patients undergo three lumbar punctures (spinal taps) - at weeks 2, 4, and 6 - to measure BDNF and various other brain chemicals. For this test, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle. The procedure generally takes from 5 to 20 minutes. Patients return to the clinic 2 weeks after completing the study medication for a final evaluation, including a physical examination and blood and urine tests.
Study identification
- NCT ID
- NCT00095355
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2004
- Primary completion
- Not listed
- Completion
- Feb 28, 2005
- Last update posted
- Mar 3, 2008
2004 – 2005
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00095355, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2008 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00095355 live on ClinicalTrials.gov.