Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095355
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-11-02
Brief Title:
Effects of Lithium and Divalproexon Brain-Derived Neurotrophic Factor in Huntingtons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Stimulation of Tyrosine Kinase and ERK Signaling Pathways in Huntingtons Disease
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Huntingtons 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 Huntingtons 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
Patients 18 to 70 years old with a DNA-confirmed diagnosis of Huntingtons 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
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 Huntingtons disease HD It is hypothesized that at safe and tolerable doses these drugs will enhance depleted levels of brain-derived neurotrophic factor BDNF a neurotrophin which is necessary for the survival of striatal neurons
Study population Patients suffering from Huntingtons disease will be study participants
Design The acute effects of lithium and divalproex on surrogate measures of neuroprotective activity will be evaluated in up to 24 HD patients The study lasting approximately 6 weeks will be conducted on an outpatient basis
Outcome measures In this proof-of-principle study efficacy in restoring BDNF concentrations will be assessed through cerebrospinal fluid CSF measurements Safety will be monitored by means of frequent clinical evaluations and laboratory test
Study population Patients suffering from Huntingtons disease will be study participants
Design The acute effects of lithium and divalproex on surrogate measures of neuroprotective activity will be evaluated in up to 24 HD patients The study lasting approximately 6 weeks will be conducted on an outpatient basis
Outcome measures In this proof-of-principle study efficacy in restoring BDNF concentrations will be assessed through cerebrospinal fluid CSF measurements Safety will be monitored by means of frequent clinical evaluations and laboratory test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0020 | None | None | None |