ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Completed
Alkermes, Inc.
Phase 3
2003-10-01
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to
further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone
(VIVITROL®).
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Terminated
Alkermes, Inc.
Phase 3
2004-08-01
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to
assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All
subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).
Planned treatment duration was up to 3 years. Alkermes terminated the study for business
purposes in December 2006. The median duration of treatment among all subjects in this
extension study was 43 weeks.
Naltrexone & SSRI in Alcoholics With Depression/PTSD
Completed
Yale University
Phase 3
2001-10-01
The purpose of this study is to evaluate the efficacy of naltrexone in combination with an
SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.
We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in
alcohol consumption than that seen with treatment with SSRI alone, or with a combination of
another class of antidepressant and naltrexone. We also hypothesize that SSRI will be
effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
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.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.