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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR APOMORPHINE HYDROCHLORIDE

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Clinical Trials for Apomorphine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00009048 EMD 128130 for the Treatment of Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 This study will evaluate the effects of an experimental drug called EMD 128130 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. EMD 128130 inhibits the function of serotonin, a chemical messenger thought to regulate dopamine release, and thus affect Parkinson's disease symptoms. Patients with relatively advanced Parkinson's disease between 30 and 80 years of age may be eligible for this 3-phase study. - Phase 1 - Baseline Evaluation Participants will have a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. A chest X-ray and MRI or CT scan of the brain will be done if needed. In addition, an ACTH stimulation test will be done before and at the end of the study. For this test, a hormone called ACTH is injected into a vein. A small amount of blood is drawn before the injection and 30 and 60 minutes afterwards to measure levels of another hormone called cortisol. After these tests are completed, patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. - Phase 2 - Levodopa and Apomorphine Dose Finding For 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa and apomorphine (a dopamine agonist) "dose-finding" procedure. For this procedure, patients will stop taking Sinemet and instead will have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce dyskinesias. - Phase 3 - Active Study Patients will begin the treatment phase within 3 months of the dose-finding phase. After a brief physical examination, routine blood tests, and evaluation of parkinsonism symptoms, patients will begin taking either EMD 128130 tablets or capsules or a placebo (a look-alike pill with no active ingredient) twice a day, along with Sinemet, for 3 weeks. All participants will receive placebo at least 1 week during the study, and about four patients, selected at random, will receive only placebo the entire 3 weeks. Levodopa and apomorphine infusions will be repeated at the end of weeks 1, 2 and 3 of Phase 3. The procedure for the infusions will be the same as in the dose-finding phase. Throughout the study, parkinsonian symptoms and dyskinesias will be assessed and blood samples will be drawn periodically to measure drug levels. Patients will return for a follow-up evaluation 2 weeks after the end of the study.
NCT00040209 JP-1730 to Treat Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 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.
NCT00142545 Long Term Safety and Efficacy of SC Apomorphine in Treatment of "Off" Episodes in Late-Stage Parkinson's Disease Completed Mylan Bertek Pharmaceuticals Phase 3 The current protocol is designed to satisfy the need for a compassionate use treatment protocol as well as for a long-term open label follow-up study.
NCT00145171 A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients. Completed Mylan Bertek Pharmaceuticals Phase 3 APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety protocol) and was designed to evaluate adverse events, particularly blood pressure drops when standing up during first dose in patients who have not been exposed to apomorphine before.
NCT00200512 Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months Completed Mylan Bertek Pharmaceuticals Phase 2/Phase 3 The objective of this study was to measure the continued efficacy of apomorphine after previous exposure of at least three months duration.
NCT00200525 Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease Completed Mylan Bertek Pharmaceuticals Phase 3 Study to measure the continued effectiveness of apomorphine after previous exposure of at least three months duration.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Apomorphine Hydrochloride

Condition Name

Condition Name for Apomorphine Hydrochloride
Intervention Trials
Parkinson's Disease 18
Parkinson Disease 9
Cocaine Related Disorders 1
Chronic Low Back Pain 1
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Condition MeSH

Condition MeSH for Apomorphine Hydrochloride
Intervention Trials
Parkinson Disease 29
Back Pain 1
Psychotic Disorders 1
Cocaine-Related Disorders 1
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Clinical Trial Locations for Apomorphine Hydrochloride

Trials by Country

Trials by Country for Apomorphine Hydrochloride
Location Trials
United States 37
France 7
United Kingdom 4
Belgium 2
Spain 2
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Trials by US State

Trials by US State for Apomorphine Hydrochloride
Location Trials
Florida 4
Georgia 3
Oregon 3
Maryland 3
Michigan 3
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Clinical Trial Progress for Apomorphine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Apomorphine Hydrochloride
Clinical Trial Phase Trials
Phase 4 4
Phase 3 8
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Apomorphine Hydrochloride
Clinical Trial Phase Trials
Completed 18
Not yet recruiting 5
Recruiting 5
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Clinical Trial Sponsors for Apomorphine Hydrochloride

Sponsor Name

Sponsor Name for Apomorphine Hydrochloride
Sponsor Trials
Mylan Bertek Pharmaceuticals 4
National Institute of Neurological Disorders and Stroke (NINDS) 4
Rennes University Hospital 3
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Sponsor Type

Sponsor Type for Apomorphine Hydrochloride
Sponsor Trials
Other 27
Industry 14
NIH 4
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