Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00095355
• Date of registration: 02/11/2004
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease
• Scientific title: Stimulation of Tyrosine Kinase and ERK Signaling Pathways in Huntington's Disease
• Date of first enrolment: October 2004
• Target sample size: 35
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00095355
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA

1. Subject is between the ages of 18 and 70 (inclusive);

2. Subject will have a diagnosis of HD confirmed by DNA testing [prior to enrollment
into the study].

3. 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.

4. 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:

1. 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;

2. Patient has clinically significant laboratory abnormalities that would preclude
administration of lithium and divalproex;

3. Patient is taking a prohibited concomitant medication;

4. 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);

5. Patient is pregnant or breastfeeding;

6. Patient has participated in a clinical study with an investigational drug within the
last 30 days;

7. Patient has a condition (such as active drug or alcohol abuse) that, in the opinion
of the investigators, would interfere with compliance or safety;

8. Patient has known hypersensitivity to lithium or divalproex;

9. Patients inability to swallow tablets or to comply with medication schedule;

10. Patient and / or caregiver are unwilling to sign an informed consent or to comply
with protocol requirements;

11. Patient is unwilling to have lumbar puncture.

12. Patient with history of severe depression, or past suicide attemps.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Lithium

Drug: Divalproex

Secondary ID(s)

050020

05-N-0020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors