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Last Updated: June 6, 2020

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CLINICAL TRIALS PROFILE FOR MEMANTINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Memantine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT01189214 Psychopharmacotherapy in Multiple Substances Abuse Completed National Institutes of Health (NIH) Phase 3 2009-03-01 Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
New Indication NCT01189214 Psychopharmacotherapy in Multiple Substances Abuse Completed National Cheng-Kung University Hospital Phase 3 2009-03-01 Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
New Indication NCT01261741 Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems Completed Merz Pharmaceuticals GmbH Phase 2 2010-11-01 In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Memantine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000867 A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1996-12-01 The purpose of this study is to determine the safety and effectiveness of memantine, an experimental drug, in improving AIDS dementia complex (ADC). The symptoms of ADC can be improved with zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, and the effectiveness of ZDV seems to decrease during the second and third years of therapy. The effectiveness of other antiretroviral drugs as treatment for ADC is not known, so it is important to explore alternative therapies.
NCT00001344 Dextromethorphan Versus Placebo for Neuropathic Pain Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1993-03-01 In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to 920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo. Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's disease. The underlying hypothesis, based on studies of painful neuropathies in animal models, is that neuropathic pain is caused largely by sensitization of central nervous system neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and consists of three 9-week treatment periods. Patients who respond to one of the medications will be invited to participate in further controlled studies of the medication followed by up to several years of open-label treatment under continued observation.
NCT00040261 Clinical Trial of Memantine for Major Depression Completed National Institute of Mental Health (NIMH) Phase 3 2002-06-01 The purpose of this study is to determine the safety and effectiveness of the drug memantine for treating major depression. Major depression is a serious public health concern that contributes to significant morbidity and mortality. Despite the availability of a wide range of antidepressant drugs, a proportion of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Recent studies suggest that the glutamatergic system may play a role in the pathophysiology and treatment of depression. Memantine and other agents which reduce glutamatergic neurotransmission may represent a novel class of antidepressants. The study consists of three phases. In Phase 1, participants will be tapered off all psychiatric medications over a 2-week washout period. In Phase 2, participants will be randomly assigned to receive either memantine or placebo (an inactive pill) three times a day for 8 weeks. Participants who do not respond to the treatment after 8 weeks will be taken off the study and offered standard treatment. Weekly psychiatric evaluations will evaluate treatment response. During Phase 2, participants who respond well to treatment will enter Phase 3, a 16-week continuation phase of either memantine or placebo. Interviews will be conducted every other week in the first month , then monthly thereafter. Participants will have a physical examination, neuropsychological tests, and eye blink tests at baseline and at the end of the study. Pulse, blood pressure, and blood samples will be taken throughout the study. Participants will undergo an electrocardiogram as well as positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain.
NCT00097916 An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease Completed Forest Laboratories Phase 3 2004-09-01 About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.
NCT00097942 Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients Completed Forest Laboratories Phase 2 2004-08-01 Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Memantine Hydrochloride

Condition Name

Condition Name for Memantine Hydrochloride
Intervention Trials
Alzheimer's Disease 36
Schizophrenia 11
Dementia 10
Alzheimer Disease 10
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Condition MeSH

Condition MeSH for Memantine Hydrochloride
Intervention Trials
Alzheimer Disease 57
Disease 26
Dementia 23
Cognition Disorders 14
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Clinical Trial Locations for Memantine Hydrochloride

Trials by Country

Trials by Country for Memantine Hydrochloride
Location Trials
United States 529
Canada 54
Spain 29
Germany 20
France 20
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Trials by US State

Trials by US State for Memantine Hydrochloride
Location Trials
California 42
New York 38
Massachusetts 27
Florida 25
Ohio 23
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Clinical Trial Progress for Memantine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Memantine Hydrochloride
Clinical Trial Phase Trials
Phase 4 58
Phase 3 41
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Memantine Hydrochloride
Clinical Trial Phase Trials
Completed 116
Recruiting 26
Unknown status 19
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Clinical Trial Sponsors for Memantine Hydrochloride

Sponsor Name

Sponsor Name for Memantine Hydrochloride
Sponsor Trials
Forest Laboratories 43
H. Lundbeck A/S 15
Massachusetts General Hospital 10
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Sponsor Type

Sponsor Type for Memantine Hydrochloride
Sponsor Trials
Other 231
Industry 97
NIH 24
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