Parkinson DiseasePhase 2NCT00040209
JP-1730 to Treat Parkinson's Disease
A Phase 2 study testing JP 1730, IV Levodopa and IV Apomorphine in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- JP 1730, IV Levodopa and IV Apomorphine
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who meet all of the following inclusion criteria at Day 0 will be eligible to participate in the study:
- Patient is between the ages of 30 and 80;
- Patient has an intact oral mucosa;
- Patient has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings;
- Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations;
- Patient is willing to adhere to protocol requirements as evidenced by written, informed consent.
Who cannot join
- Patients meeting any of the following exclusion criteria either at Day 0 or during the study will not be enrolled or will be immediately excluded from the study, as appropriate:
- Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk, including bronchospasm or lung disease, clinically significant cardiac arrhythmias and/or myocardial ischemia; baseline bundle branch block or QTc greater than 480 msec;
- Patient has clinically significant laboratory abnormalities including liver enzyme elevation greater than twice the upper limit of normal;
- Patient is unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipaxole or ropinirole;
- Patient is taking a prohibited concomitant medication;
- Patient has not been using an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal (if female);
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- Patient is pregnant or breastfeeding;
- Patient is implanted with bilateral deep brain stimulators;
- Patient has prior bilateral pallidotomy or other ablative surgeries for treatment of PD;
- Patient has cognitive impairment (MMSE less than 25);
- Patients with known history of chronic adrenal pituitary insufficiency, pituitary insufficiency, or clinically significant laboratory abnormalities suggestive of adrenal insufficiency, such as an elevated ACTH level;
- Patient has an obvious oral mucosa abnormality;
- 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 is unwilling to sign an informed consent or to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Alpha-2 Adrenergic Antagonist Treatment of Parkinson's Disease
This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms.
Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be eligible for this 3-phase study.
Read more
- Phase 1 - Baseline evaluation
Participants will be evaluated with a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. (If necessary, patients may use short-acting dopamine agonists, such as Mirapex and Requip.)
- Phase 2 - Dose Finding Phase
For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet and instead have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, 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. Symptoms are monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study.)
- Phase 3 - Active Study Phase
Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the first week and then approximately twice a week for the next 2 weeks. For these doses, patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All participants will receive placebo at some time during the study, and a few patients, selected at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also, small blood samples are drawn up to three times each study day. At the end of the third week, patients will be discharged from the hospital. Their anti-parkinsonian medications may be readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the clinic.
In addition to the above procedures, patients will be asked to have an optional lumbar a puncture (spinal tap) on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
Read the detailed description
The objective of this study is to evaluate the effects of selective alpha-2 adrenergic receptor antagonism on the severity of parkinsonian signs and dopaminomimetic drug-associated motor response complications in patients with mild to moderately advanced Parkinson's disease. In a controlled proof-of-principle clinical study, the acute efficacy of JP-1730 will be assessed through the use of validated motor function scales. Safety will be monitored by means of frequent clinical evaluations and laboratory tests.
- Conditions
- Parkinson Disease
- Being tested
- JP 1730, IV Levodopa, IV Apomorphine
- Keywords
- JP 1730, Dyskinesias, Levodopa Infusion, Apomorphine Infusion, Clinical Trial, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP 1730Drug
IV LevodopaDrug
IV ApomorphineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2002 (estimated)
- Study startJun 2002
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040209
- Sponsor's protocol ID
- 020236
- Other IDs
- 02-N-0236
- Status last verified
- Jul 2005
- First submitted
- 21 Jun 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Chase TN, Oh JD, Blanchet PJ. Neostriatal mechanisms in Parkinson's disease. Neurology. 1998 Aug;51(2 Suppl 2):S30-5. doi: 10.1212/wnl.51.2_suppl_2.s30.
PubMed 9711978Mizuno Y, Mori H, Kondo T. Parkinson's disease: from etiology to treatment. Intern Med. 1995 Nov;34(11):1045-54. doi: 10.2169/internalmedicine.34.1045.
PubMed 8774962Miyawaki E, Lyons K, Pahwa R, Troster AI, Hubble J, Smith D, Busenbark K, McGuire D, Michalek D, Koller WC. Motor complications of chronic levodopa therapy in Parkinson's disease. Clin Neuropharmacol. 1997 Dec;20(6):523-30. doi: 10.1097/00002826-199712000-00004.
PubMed 9403226
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-2 Adrenergic Antagonist Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00040209
- Acronym / sponsor ID
- 020236
- Conditions
- Parkinson Disease
- Keywords
- JP 1730, Dyskinesias, Levodopa Infusion, Apomorphine Infusion, Clinical Trial, Parkinson Disease, PD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- Jul 2005
- First posted
- 24 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms.
Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be eligible for this 3-phase study.
- Phase 1 - Baseline evaluation
Participants will be evaluated with a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. (If necessary, patients may use short-acting dopamine agonists, such as Mirapex and Requip.)
- Phase 2 - Dose Finding Phase
For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet and instead have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, 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. Symptoms are monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study.)
- Phase 3 - Active Study Phase
Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the first week and then approximately twice a week for the next 2 weeks. For these doses, patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All participants will receive placebo at some time during the study, and a few patients, selected at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also, small blood samples are drawn up to three times each study day. At the end of the third week, patients will be discharged from the hospital. Their anti-parkinsonian medications may be readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the clinic.
In addition to the above procedures, patients will be asked to have an optional lumbar a puncture (spinal tap) on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
Detailed description
The objective of this study is to evaluate the effects of selective alpha-2 adrenergic receptor antagonism on the severity of parkinsonian signs and dopaminomimetic drug-associated motor response complications in patients with mild to moderately advanced Parkinson's disease. In a controlled proof-of-principle clinical study, the acute efficacy of JP-1730 will be assessed through the use of validated motor function scales. Safety will be monitored by means of frequent clinical evaluations and laboratory tests.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who meet all of the following inclusion criteria at Day 0 will be eligible to participate in the study:
- Patient is between the ages of 30 and 80;
- Patient has an intact oral mucosa;
- Patient has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurologic findings;
- Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations;
Key exclusion criteria (15 listed)
- Patients meeting any of the following exclusion criteria either at Day 0 or during the study will not be enrolled or will be immediately excluded from the study, as appropriate:
- Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk, including bronchospasm or lung disease, clinically significant cardiac arrhythmias and/or myocardial ischemia; baseline bundle branch block or QTc greater than 480 msec;
- Patient has clinically significant laboratory abnormalities including liver enzyme elevation greater than twice the upper limit of normal;
- Patient is unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipaxole or ropinirole;
- Patient is taking a prohibited concomitant medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JP 1730 | Drug | – |
| IV Levodopa | Drug | – |
| IV Apomorphine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9711978Chase TN, Oh JD, Blanchet PJ. Neostriatal mechanisms in Parkinson's disease. Neurology. 1998 Aug;51(2 Suppl 2):S30-5. doi: 10.1212/wnl.51.2_suppl_2.s30.
- Background: PubMed 8774962Mizuno Y, Mori H, Kondo T. Parkinson's disease: from etiology to treatment. Intern Med. 1995 Nov;34(11):1045-54. doi: 10.2169/internalmedicine.34.1045.
- Background: PubMed 9403226Miyawaki E, Lyons K, Pahwa R, Troster AI, Hubble J, Smith D, Busenbark K, McGuire D, Michalek D, Koller WC. Motor complications of chronic levodopa therapy in Parkinson's disease. Clin Neuropharmacol. 1997 Dec;20(6):523-30. doi: 10.1097/00002826-199712000-00004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JP 1730, IV Levodopa and IV Apomorphine in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00040209, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 7 Nov 2026.