Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108667
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-04-15
Brief Title:
Talampanel to Treat Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
AMPA Receptor Antagonist Treatment of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2006-02
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 evaluate the effects of the experimental drug talampanel on dyskinesias involuntary movements that develop in patients with Parkinsons disease as a result of long-term treatment with levodopa Sinemet The drug will be tested alone and in combination with amantadine-a drug commonly used to alleviate dyskinesias
Patients between 21 and 80 years of age with Parkinsons disease and dyskinesias may be eligible for this study
Screening and baseline evaluation Participants are evaluated with a medical history physical and neurologic examinations blood and urine tests electrocardiogram EKG and pregnancy test if applicable A chest x-ray and MRI or CT scan of the brain are done if needed Patients stop taking all antiparkinsonian medications for one month 2 months if taking Selegiline before the study begins and throughout its duration except for certain medicines allowed including Sinemet Mirapex and Requip Amantadine can be taken up to 1 week before beginning the study
Dose-finding phase Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa dose-finding procedure For this test patients stop taking Sinemet and instead have it infused through a vein During the infusions the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached Symptoms are monitored frequently At given times during the infusion saline is given instead of Sinemet The infusions usually begin in the early morning and continue until evening Patients resume taking Sinemet between infusions Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study
After the dose-finding phase patients are randomly assigned to take placebo a sugar pill or talampanel Those taking talampanel also receive amantadine at their usual dosages At some point in the study amantadine is replaced with placebo Patients in the talampanel group also receive placebo for portions of the study
Active study phase At study weeks 1 5 and 7 patients are admitted to the Clinical Center overnight for a levodopa infusion with talampanel or placebo The day before the infusion patients have a brief physical examination blood and urine tests an EKG and a review of symptoms or changes in their condition The next day they receive an infusion of levodopa at the dose determined in the dose-finding phase Then they take a pill containing either talampanel or placebo Their parkinsonian symptoms and dyskinesias are evaluated and videotaped every 30 minutes for about 6 hours Blood is drawn and an EKG is obtained At the end of the infusions and ratings patients resume their regular Parkinsons medications and are given a new supply of study medications to take home
At weeks 2 3 4 and 6 patients come to the Clinical Center for a review of drug side effects They have blood drawn and receive a new supply of study medications that last until the next visit
Follow-up Two weeks after the study ends patients are contacted by phone for a review of side effects or they return to the clinic for an evaluation
Patients between 21 and 80 years of age with Parkinsons disease and dyskinesias may be eligible for this study
Screening and baseline evaluation Participants are evaluated with a medical history physical and neurologic examinations blood and urine tests electrocardiogram EKG and pregnancy test if applicable A chest x-ray and MRI or CT scan of the brain are done if needed Patients stop taking all antiparkinsonian medications for one month 2 months if taking Selegiline before the study begins and throughout its duration except for certain medicines allowed including Sinemet Mirapex and Requip Amantadine can be taken up to 1 week before beginning the study
Dose-finding phase Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa dose-finding procedure For this test patients stop taking Sinemet and instead have it infused through a vein During the infusions the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached Symptoms are monitored frequently At given times during the infusion saline is given instead of Sinemet The infusions usually begin in the early morning and continue until evening Patients resume taking Sinemet between infusions Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study
After the dose-finding phase patients are randomly assigned to take placebo a sugar pill or talampanel Those taking talampanel also receive amantadine at their usual dosages At some point in the study amantadine is replaced with placebo Patients in the talampanel group also receive placebo for portions of the study
Active study phase At study weeks 1 5 and 7 patients are admitted to the Clinical Center overnight for a levodopa infusion with talampanel or placebo The day before the infusion patients have a brief physical examination blood and urine tests an EKG and a review of symptoms or changes in their condition The next day they receive an infusion of levodopa at the dose determined in the dose-finding phase Then they take a pill containing either talampanel or placebo Their parkinsonian symptoms and dyskinesias are evaluated and videotaped every 30 minutes for about 6 hours Blood is drawn and an EKG is obtained At the end of the infusions and ratings patients resume their regular Parkinsons medications and are given a new supply of study medications to take home
At weeks 2 3 4 and 6 patients come to the Clinical Center for a review of drug side effects They have blood drawn and receive a new supply of study medications that last until the next visit
Follow-up Two weeks after the study ends patients are contacted by phone for a review of side effects or they return to the clinic for an evaluation
Detailed Description:
Objective to evaluate the acute effects of talampanel a novel antagonist of AMPA type glutamate receptors on the severity of parkinsonian signs and levodopa-associated motor response complications
Study Population patients with moderately advanced Parkinsons disease and dopaminergic therapy related motor complications between the age of 21 and 80
Study Design randomized controlled proof-of-principle pilot study lasting approximately 7 weeks
Study Outcome Parameters the pharmacokinetic characteristics of orally administered talampanel will be measured by means of plasma drug assays its therapeutic efficacy will be evaluated using validated motor function scales and safety will be monitored by means of frequent clinical evaluations and laboratory tests
Study Population patients with moderately advanced Parkinsons disease and dopaminergic therapy related motor complications between the age of 21 and 80
Study Design randomized controlled proof-of-principle pilot study lasting approximately 7 weeks
Study Outcome Parameters the pharmacokinetic characteristics of orally administered talampanel will be measured by means of plasma drug assays its therapeutic efficacy will be evaluated using validated motor function scales and safety will be monitored by means of frequent clinical evaluations and laboratory tests
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-0139 | None | None | None |