Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Dow
McKinsey
Baxter
Moodys

Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR RILUTEK


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


All Clinical Trials for Rilutek

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00026052 ↗ Riluzole to Treat Major Depression Completed National Institute of Mental Health (NIMH) Phase 2 2001-11-01 This study will examine the safety and effectiveness of the drug riluzole (Rilutek® (Registered Trademark)) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major depression do not respond to first-line antidepressant treatment with drugs such as fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes in the brain that may also have antidepressant properties. Patients between 18 and 70 years of age with major depressive disorder without psychotic features may be eligible for this 2-stage 7-week study. Candidates will be screened with a medical history and physical examination, including an electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. A blood or urine sample will be tested for illegal drugs.Women of childbearing potential will have a pregnancy test. Participants will complete stage 1 of the study, which lasts 1 week, and may then continue with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered off all psychiatric medicines and will begin treatment with a placebo (a sugar pill formulated to look like the active drug). At some point, they will be switched from placebo to riluzole. In addition, participants will undergo the following procedures: - Physical examination and electrocardiograms (EKG) at the beginning and end of the study, with vital signs (temperature, blood pressure and heart rate) checked daily - Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response - Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features, will in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a period of 6 weeks. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than 50% improvement on the primary efficacy measure, then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial.
NCT00047723 ↗ Minocycline to Treat Amyotrophic Lateral Sclerosis Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 2003-01-01 The purpose of this trial is to test the safety, tolerability, and effectiveness of minocycline compared to placebo in patients with amyotrophic lateral sclerosis (ALS).
NCT00054704 ↗ Riluzole to Treat Depression in Bipolar Disorder Terminated National Institute of Mental Health (NIMH) Phase 2 2003-02-01 This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in Bipolar Disorder. Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients. Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study. Candidates must be currently depressed, must have had at least one previous major depressive episode, and must have failed to improve with prior treatment with at least one antidepressant. They will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing potential will have a pregnancy test. Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill formulated to look like the active drug) and, at some point, switching to riluzole. In addition to drug treatment, participants will undergo the following procedures: Physical examination and electrocardiogram (EKG) at the beginning and end of the study; Weekly check of vital signs (temperature, blood pressure and heart rate); Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response; Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects. At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Atendemos pacientes de habla hispana. We enroll eligible participants locally and from around the country. Travel arrangements are provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements vary by distance and by specific study.) After completing the study participants receive short-term follow-up care while transitioning back to a provider.
NCT00251303 ↗ Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders Completed National Institute of Mental Health (NIMH) Phase 2 2005-08-01 This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive Disorder in Youth, Including those with Autism Spectrum Disorders.
NCT00353665 ↗ Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS) Completed H. Lundbeck A/S Phase 2/Phase 3 2005-07-01 The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).
NCT00353665 ↗ Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS) Completed University of Lisbon Phase 2/Phase 3 2005-07-01 The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rilutek

Condition Name

Condition Name for Rilutek
Intervention Trials
Amyotrophic Lateral Sclerosis 8
Bipolar Disorder 2
Amyotrophic Lateral Sclerosis (ALS) 2
Depression 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Rilutek
Intervention Trials
Sclerosis 11
Motor Neuron Disease 11
Amyotrophic Lateral Sclerosis 11
Depression 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Rilutek

Trials by Country

Trials by Country for Rilutek
Location Trials
United States 80
Canada 17
Spain 3
Germany 3
France 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Rilutek
Location Trials
Maryland 8
New York 4
Massachusetts 4
Ohio 4
California 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Rilutek

Clinical Trial Phase

Clinical Trial Phase for Rilutek
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2/Phase 3 4
[disabled in preview] 15
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Rilutek
Clinical Trial Phase Trials
Completed 21
Recruiting 3
Active, not recruiting 2
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Rilutek

Sponsor Name

Sponsor Name for Rilutek
Sponsor Trials
National Institute of Mental Health (NIMH) 4
Stanley Medical Research Institute 2
Yale University 2
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Rilutek
Sponsor Trials
Other 36
Industry 10
NIH 7
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
McKinsey
Moodys
Merck
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.