Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086294
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-06-29
Brief Title:
ACP-103 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:
5HT2AC Serotonin Blockade in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2007-11-15
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 an experimental drug called ACP-103 on Parkinsons disease symptoms and on dyskinesias involuntary movements that develop as a result of long-term levodopa treatment ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinsons disease
Patients with relatively advanced Parkinsons disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study Candidates are screened with a complete medical history and physical examination neurological evaluation blood and urine tests and electrocardiogram ECG A brain magnetic resonance imaging MRI scan CT scan and chest x-ray may be done if medically indicated
Patients enrolled in the study will if possible stop taking all antiparkinsonian medications for one month 2 months for Selegiline before the study begins and throughout its duration Exceptions are Sinemet levodopacarbidopa Mirapex pramipexole and Requip ropinirole
Levodopa Dose Finding
After the screening evaluations patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa dose-finding procedure For this test patients stop taking Sinemet and instead have levodopa infused through a vein During the infusion the drug dose is increased slowly until either 1 parkinsonian symptoms improve 2 unacceptable side effects occur or 3 the maximum study dose is reached Side effects are monitored closely during the infusions and parkinsonian symptoms are evaluated frequently during and after the infusions The infusions usually begin early in the morning and continue until evening Once the infusion is finished patients resume taking their regular oral Sinemet dose The infusions are repeated once a week during 1-day inpatient evaluations
Treatment
Patients are randomly assigned to take either ACP-103 followed by placebo a look-alike pill with no active ingredient once a week for 10 weeks or vice versa placebo followed by ACP-103 Patients are admitted to the Clinical Center for each dose During this admission they have a brief medical examination blood and urine tests ECG and review of symptoms or changes in their condition They also have an infusion of levodopa see above at the previously determined optimal rate Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours At the end of the infusions and ratings patients are discharged home with their regular Parkinsons medications until the following visit
Two weeks after their final dose of ACP-103 or placebo patients are contact by telephone for a follow-up safety check At that time the investigator may ask the patient to return to the clinic for closer evaluation
Patients with relatively advanced Parkinsons disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study Candidates are screened with a complete medical history and physical examination neurological evaluation blood and urine tests and electrocardiogram ECG A brain magnetic resonance imaging MRI scan CT scan and chest x-ray may be done if medically indicated
Patients enrolled in the study will if possible stop taking all antiparkinsonian medications for one month 2 months for Selegiline before the study begins and throughout its duration Exceptions are Sinemet levodopacarbidopa Mirapex pramipexole and Requip ropinirole
Levodopa Dose Finding
After the screening evaluations patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa dose-finding procedure For this test patients stop taking Sinemet and instead have levodopa infused through a vein During the infusion the drug dose is increased slowly until either 1 parkinsonian symptoms improve 2 unacceptable side effects occur or 3 the maximum study dose is reached Side effects are monitored closely during the infusions and parkinsonian symptoms are evaluated frequently during and after the infusions The infusions usually begin early in the morning and continue until evening Once the infusion is finished patients resume taking their regular oral Sinemet dose The infusions are repeated once a week during 1-day inpatient evaluations
Treatment
Patients are randomly assigned to take either ACP-103 followed by placebo a look-alike pill with no active ingredient once a week for 10 weeks or vice versa placebo followed by ACP-103 Patients are admitted to the Clinical Center for each dose During this admission they have a brief medical examination blood and urine tests ECG and review of symptoms or changes in their condition They also have an infusion of levodopa see above at the previously determined optimal rate Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours At the end of the infusions and ratings patients are discharged home with their regular Parkinsons medications until the following visit
Two weeks after their final dose of ACP-103 or placebo patients are contact by telephone for a follow-up safety check At that time the investigator may ask the patient to return to the clinic for closer evaluation
Detailed Description:
Introduction In Parkinsons disease PD levodopa-induced dyskinesias and motor fluctuations are frequent disabling complications Therefore it is imperative to find nondopaminergic approaches to the palliation of parkinsonian signs Previously we demonstrated that drugs that block 5HT2A receptors benefit motor dysfunction in parkinsonian animals
Objective To test our hypothesis that blockade of serotonin 2A2C receptors 5HT2AC will lessen the severity of parkinsonian signs and levodopa-associated motor response complications in PD patients
Methods In a placebo-controlled proof-of-principle study the effect of the 5HT2AC receptor inverse agonist ACP-103 on levodopa induced motor complications and parkinsonian signs will be assessed in up to 20 patients with moderately advanced Parkinsons disease Efficacy will be assessed through the use of validated motor function scales Safety will be monitored by means of frequent clinical evaluations and laboratory tests
Risks and benefits Risks involved in this study are a minor increase over minimal risks and are deemed reasonable in relation to potential benefits This investigation should lead to a better understanding of the pathophysiology and treatment of levodopa-induced motor complications in PD
Objective To test our hypothesis that blockade of serotonin 2A2C receptors 5HT2AC will lessen the severity of parkinsonian signs and levodopa-associated motor response complications in PD patients
Methods In a placebo-controlled proof-of-principle study the effect of the 5HT2AC receptor inverse agonist ACP-103 on levodopa induced motor complications and parkinsonian signs will be assessed in up to 20 patients with moderately advanced Parkinsons disease Efficacy will be assessed through the use of validated motor function scales Safety will be monitored by means of frequent clinical evaluations and laboratory tests
Risks and benefits Risks involved in this study are a minor increase over minimal risks and are deemed reasonable in relation to potential benefits This investigation should lead to a better understanding of the pathophysiology and treatment of levodopa-induced motor complications in PD
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 |
|---|---|---|---|
| 04-N-0225 | None | None | None |