Status:
COMPLETED
Effects of Lithium and Divalproex'on Brain-Derived Neurotrophic Factor in Huntington's Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Huntington's Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 di...
Detailed Description
Objective: The overall objective of this study is to examine the acute effects of lithium alone and/ or in combination with divalproex on markers of neuroprotective activity in patients with Huntingto...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Subject is between the ages of 18 and 70 (inclusive);
- Subject will have a diagnosis of HD confirmed by DNA testing \[prior to enrollment into the study\].
- Only those subjects will be eligible, who with or without a caregiver, can be assumed to be able to comply with study requirements and to report on their condition by telephone.
- Subjects with minimental status examination score of greater than and equal to 24.
- EXCLUSION CRITERIA
- Patients meeting any of the following exclusion criteria during screening or during the study will not be immediately excluded from the study, as appropriate:
- Patient has a history of any medical condition such as diabetes, cardiac disease, renal impairment, liver disease, pancreatitis and other chronic medical problems that can reasonably be expected to subject the patient to unwarranted risk;
- Patient has clinically significant laboratory abnormalities that would preclude administration of lithium and divalproex;
- Patient is taking a prohibited concomitant medication;
- Patient has not been using an adequate contraceptive method for the last 30 days or unwilling to continue contraception throughout the study, or is not at least one year post menopausal (if female);
- Patient is pregnant or breastfeeding;
- Patient has participated in a clinical study with an investigational drug within the last 30 days;
- Patient has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety;
- Patient has known hypersensitivity to lithium or divalproex;
- Patients inability to swallow tablets or to comply with medication schedule;
- Patient and / or caregiver are unwilling to sign an informed consent or to comply with protocol requirements;
- Patient is unwilling to have lumbar puncture.
- Patient with history of severe depression, or past suicide attemps.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00095355
Start Date
October 1 2004
End Date
March 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892