➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Baxter
Merck
Colorcon
Johnson and Johnson

Last Updated: October 24, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR METHADONE HYDROCHLORIDE

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

505(b)(2) Clinical Trials for Methadone 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New Formulation NCT00505583 Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy Withdrawn Valeant Pharmaceuticals International, Inc. Phase 1 2007-07-01 To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.
New Formulation NCT00640159 Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease Completed Baylor College of Medicine Phase 4 2007-01-01 Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Methadone Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000200 Cocaine Effects in Humans: Physiology and Behavior - 1 Completed Columbia University Phase 2 1997-01-01 The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.
NCT00000200 Cocaine Effects in Humans: Physiology and Behavior - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-01-01 The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.
NCT00000205 Buprenorphine Maintenance Protocol - 1 Completed National Institute on Drug Abuse (NIDA) Phase 3 1990-10-01 The purpose of this study is to compare the efficacy of buprenorphine versus methadone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Methadone Hydrochloride

Condition Name

Condition Name for Methadone Hydrochloride
Intervention Trials
Opioid-Related Disorders 35
Pain 31
Opioid Dependence 30
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Methadone Hydrochloride
Intervention Trials
Opioid-Related Disorders 64
Substance-Related Disorders 36
Pain, Postoperative 28
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Methadone Hydrochloride

Trials by Country

Trials by Country for Methadone Hydrochloride
Location Trials
United States 320
Canada 30
Norway 9
Brazil 8
Germany 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Methadone Hydrochloride
Location Trials
New York 39
Maryland 35
California 28
Illinois 19
Connecticut 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Methadone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Methadone Hydrochloride
Clinical Trial Phase Trials
Phase 4 71
Phase 3 47
Phase 2/Phase 3 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Methadone Hydrochloride
Clinical Trial Phase Trials
Completed 155
Recruiting 59
Not yet recruiting 36
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Methadone Hydrochloride

Sponsor Name

Sponsor Name for Methadone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 81
Yale University 22
Johns Hopkins University 19
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Methadone Hydrochloride
Sponsor Trials
Other 364
NIH 108
Industry 59
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
McKesson
Harvard Business School
Johnson and Johnson
Dow

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.