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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR PRAMIPEXOLE DIHYDROCHLORIDE

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Clinical Trials for Pramipexole Dihydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00025792 Clinical Trial of Pramipexole in Bipolar Depression Completed National Institute of Mental Health (NIMH) Phase 2 The purpose of this study is to examine the safety and effectiveness of the drug pramipexole given in combination with lithium or divalproex for the short-term treatment of acute depression in patients with bipolar disorder. Bipolar disorder is a severe, chronic, and often life-threatening illness. Treatments for acute unipolar depression have been extensively researched. However, despite the availability of a wide range of antidepressant drugs, a significant proportion of depressed patients fail to respond to first-line antidepressant treatment. Novel and improved therapeutics for bipolar depression are needed. This study will evaluate the antidepressant properties of pramipexole. This study will be conducted in three phases. Phase 1 is a 14-day washout period in which participants will be tapered off all their psychiatric medicines except divalproex or lithium. Participants will also be asked to adhere to a low caffeine and low monoamine diet. During Phase 2, participants will be randomly assigned to receive either pramipexole or placebo (an inactive pill) for 6 weeks. Participants who respond to treatment will be given either open-label pramipexole or another clinical treatment. Participants will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. Women of childbearing potential will have a pregnancy test. Participants will have a physical exam and EKG at study entry and study completion. Blood will be drawn at various times throughout the study. Pulse and blood pressure measurements will be taken daily. Weekly interviews will be conducted. Participants and a control group of healthy volunteers will undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain.
NCT00086294 ACP-103 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 ACP-103 on Parkinson's 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 Parkinson's disease. Patients with relatively advanced Parkinson's 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 (levodopa/carbidopa), 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 Parkinson's 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.
NCT00086307 Lexapro and Pramipexole and to Treat Major Depression Completed National Institute of Mental Health (NIMH) Phase 2 This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study. Candidates must currently be in a major depressive episode of at least 4 weeks' duration, have failed to respond to treatment with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more than four antidepressants for the current episode. Candidates are screened with a physical examination, psychiatric evaluation, blood tests, review of vital signs, height and weight measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for women. Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment. They are then randomly assigned to take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks. During the study, participants come to the clinic eight times for health assessments and symptoms assessments, which include a check of vital signs and rating scales for depression and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected periodically to monitor health, detect pregnancy in women, and detect illicit drug use. At the end of the 6-week treatment period, participants have a physical examination, ECG, blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and plans are made for long-term treatment. Atendemos pacientes de habla hispana.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pramipexole Dihydrochloride

Condition Name

Condition Name for Pramipexole Dihydrochloride
Intervention Trials
Parkinson Disease 31
Restless Legs Syndrome 20
Healthy 11
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Condition MeSH

Condition MeSH for Pramipexole Dihydrochloride
Intervention Trials
Parkinson Disease 47
Syndrome 21
Restless Legs Syndrome 21
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Clinical Trial Locations for Pramipexole Dihydrochloride

Trials by Country

Trials by Country for Pramipexole Dihydrochloride
Location Trials
United States 264
Germany 25
Austria 11
Italy 9
Spain 9
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Trials by US State

Trials by US State for Pramipexole Dihydrochloride
Location Trials
New York 17
Florida 16
Massachusetts 14
California 14
Georgia 13
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Clinical Trial Progress for Pramipexole Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Pramipexole Dihydrochloride
Clinical Trial Phase Trials
Phase 4 26
Phase 3 29
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Pramipexole Dihydrochloride
Clinical Trial Phase Trials
Completed 82
Terminated 5
Recruiting 5
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Clinical Trial Sponsors for Pramipexole Dihydrochloride

Sponsor Name

Sponsor Name for Pramipexole Dihydrochloride
Sponsor Trials
Boehringer Ingelheim 57
National Institute of Mental Health (NIMH) 6
Bennett, James P., Jr., M.D., Ph.D. 3
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Sponsor Type

Sponsor Type for Pramipexole Dihydrochloride
Sponsor Trials
Industry 80
Other 46
NIH 8
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