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3 Diseases | | 2 Products |
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3 Trials |  |
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- ||||| ganaxolone IV / Marinus
New P2 trial: Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus (clinicaltrials.gov) - Nov 22, 2017
P2, N=250, Not yet recruiting, Sponsor: Marinus Pharmaceuticals
- Ztalmy (ganaxolone oral) / Marinus
Trial primary completion date: Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) - Sep 25, 2017
P2, N=50, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
Trial primary completion date: Jun 2017 --> Jan 2018
- | Ztalmy (ganaxolone oral) / Marinus
Enrollment closed: Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) - Jul 25, 2017
P2, N=50, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
Trial primary completion date: Jun 2017 --> Jan 2018 Recruiting --> Active, not recruiting
- | ganaxolone IV / Marinus
New P2a trial: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression (clinicaltrials.gov) - Jul 24, 2017
P2a, N=30, Recruiting, Sponsor: Marinus Pharmaceuticals
- Ztalmy (ganaxolone oral) / Marinus
Enrollment change, Trial termination, Trial primary completion date: A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures (clinicaltrials.gov) - Jan 9, 2017
P3, N=26, Terminated, Sponsor: Marinus Pharmaceuticals
N=170 --> 26 | Enrolling by invitation --> Terminated | Trial primary completion date: Nov 2017 --> Dec 2016; Ganaxolone missed its primary endpoint in the double-blind portion of the 1042-0603 study. Due to this outcome Marinus discontinued this extension study.
- ||||||| Ztalmy (ganaxolone oral) / Marinus
Trial completion, Enrollment change, Trial primary completion date: Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (clinicaltrials.gov) - Jan 4, 2017
P3, N=405, Completed, Sponsor: Marinus Pharmaceuticals
Due to this outcome Marinus discontinued this extension study. Active, not recruiting --> Completed | N=292 --> 405 | Trial primary completion date: Nov 2015 --> May 2016
- Ztalmy (ganaxolone oral) / Marinus
Enrollment open: Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone (clinicaltrials.gov) - Nov 18, 2016
P=N/A, N=10, Recruiting, Sponsor: Massachusetts General Hospital
Active, not recruiting --> Completed | N=292 --> 405 | Trial primary completion date: Nov 2015 --> May 2016 Not yet recruiting --> Recruiting
- | Ztalmy (ganaxolone oral) / Marinus
Enrollment change, Trial primary completion date: Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) - Sep 23, 2016
P2, N=50, Recruiting, Sponsor: Marinus Pharmaceuticals
Not yet recruiting --> Recruiting N=20 --> 50 | Trial primary completion date: Jun 2016 --> Jun 2017
- Ztalmy (ganaxolone oral) / Marinus
New trial: Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone (clinicaltrials.gov) - Sep 14, 2016
P=N/A, N=10, Not yet recruiting, Sponsor: Massachusetts General Hospital
- Ztalmy (ganaxolone oral) / Marinus
New trial: Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone (clinicaltrials.gov) - May 10, 2016
P=N/A, N=10, Not yet recruiting, Sponsor: Massachusetts General Hospital
- || Ztalmy (ganaxolone oral) / Marinus
Trial primary completion date: Ganaxolone Treatment in Children With Fragile X Syndrome (clinicaltrials.gov) - Mar 16, 2016
P2, N=60, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
N=20 --> 50 | Trial primary completion date: Jun 2016 --> Jun 2017 Trial primary completion date: Dec 2015 --> Jun 2016
- | Ztalmy (ganaxolone oral) / Marinus
Enrollment change, Trial primary completion date: Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) - Jan 15, 2016
P2, N=20, Recruiting, Sponsor: Marinus Pharmaceuticals
Trial primary completion date: Dec 2015 --> Jun 2016 N=10 --> 20 | Trial primary completion date: Dec 2015 --> Jun 2016
- ||||| Ztalmy (ganaxolone oral) / Marinus
Enrollment closed: Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (clinicaltrials.gov) - Dec 21, 2015
P3, N=292, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
N=10 --> 20 | Trial primary completion date: Dec 2015 --> Jun 2016 Recruiting --> Active, not recruiting
- |||| Ztalmy (ganaxolone oral) / Marinus
Trial completion: Ganaxolone in Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Oct 21, 2015
P2, N=114, Completed, Sponsor: Marinus Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || Ztalmy (ganaxolone oral) / Marinus
Trial primary completion date: Ganaxolone Treatment in Children With Fragile X Syndrome (clinicaltrials.gov) - Oct 5, 2015
P2, N=60, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
Active, not recruiting --> Completed Trial primary completion date: Sep 2015 --> Dec 2015
- ||| Ztalmy (ganaxolone oral) / Marinus
Enrollment closed: Ganaxolone Treatment in Children With Fragile X Syndrome (clinicaltrials.gov) - Sep 30, 2015
P2, N=60, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
Trial primary completion date: Sep 2015 --> Dec 2015 Recruiting --> Active, not recruiting
- |||||||||| Ztalmy (ganaxolone oral) / Marinus
New P3 trial: A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures (clinicaltrials.gov) - Aug 11, 2015
P3, N=170, Enrolling by invitation, Sponsor: Marinus Pharmaceuticals
- |||| Ztalmy (ganaxolone oral) / Marinus
Trial primary completion date: Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (clinicaltrials.gov) - Jun 11, 2015
P3, N=292, Recruiting, Sponsor: Marinus Pharmaceuticals
Recruiting --> Active, not recruiting Trial primary completion date: Jun 2015 --> Nov 2015
- Ztalmy (ganaxolone oral) / Marinus
Enrollment open: Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) - Mar 17, 2015
P2, N=10, Recruiting, Sponsor: Marinus Pharmaceuticals
Trial primary completion date: Jun 2015 --> Nov 2015 Not yet recruiting --> Recruiting
- Ztalmy (ganaxolone oral) / Marinus
New P2 trial: Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies (clinicaltrials.gov) - Feb 9, 2015
P2, N=10, Not yet recruiting, Sponsor: Marinus Pharmaceuticals
- ||||| Ztalmy (ganaxolone oral) / Marinus
Phase classification, Enrollment change: Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (clinicaltrials.gov) - Oct 4, 2014
P3, N=292, Recruiting, Sponsor: Marinus Pharmaceuticals
Not yet recruiting --> Recruiting Phase classification: P2 --> P3 | N=150 --> 292
- Ztalmy (ganaxolone oral) / Marinus
Trial completion: Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate (clinicaltrials.gov) - Sep 8, 2014
P2, N=36, Completed, Sponsor: Jed E. Rose
Phase classification: P2 --> P3 | N=150 --> 292 Active, not recruiting --> Completed
- |||| Ztalmy (ganaxolone oral) / Marinus
Enrollment open: Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (clinicaltrials.gov) - Nov 5, 2013
P2, N=150, Recruiting, Sponsor: Marinus Pharmaceuticals
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| Ztalmy (ganaxolone oral) / Marinus
New P2 trial: Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (clinicaltrials.gov) - Oct 14, 2013
P2, N=150, Recruiting, Sponsor: Marinus Pharmaceuticals
- ||| Ztalmy (ganaxolone oral) / Marinus
Enrollment change: Open-label Extension to Protocol 1042-0600 (clinicaltrials.gov) - Oct 13, 2013
P2, N=125, Completed, Sponsor: Marinus Pharmaceuticals
Not yet recruiting --> Recruiting N=161 --> 125
- ||| Ztalmy (ganaxolone oral) / Marinus
Enrollment closed: Ganaxolone in Posttraumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Oct 13, 2013
P2, N=114, Active, not recruiting, Sponsor: Marinus Pharmaceuticals
N=161 --> 125 Recruiting --> Active, not recruiting
- | Ztalmy (ganaxolone oral) / Marinus
Trial completion: A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601 (clinicaltrials.gov) - Oct 13, 2013
P2, N=11, Completed, Sponsor: Marinus Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||| Ztalmy (ganaxolone oral) / Marinus
Trial completion: Open-label Extension to Protocol 1042-0600 (clinicaltrials.gov) - Oct 13, 2013
P2, N=125, Completed, Sponsor: Marinus Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Ztalmy (ganaxolone oral) / Marinus
Enrollment change: Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate (clinicaltrials.gov) - Sep 24, 2013
P2, N=36, Active, not recruiting, Sponsor: Jed E. Rose
Active, not recruiting --> Completed N=200 --> 36
- Ztalmy (ganaxolone oral) / Marinus
Enrollment closed: Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate (clinicaltrials.gov) - Aug 18, 2013
P2, N=36, Active, not recruiting, Sponsor: Jed E. Rose
N=200 --> 36 Recruiting --> Active, not recruiting
- Ztalmy (ganaxolone oral) / Marinus
New P2 trial: Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate (clinicaltrials.gov) - May 16, 2013
P2, N=36, Active, not recruiting, Sponsor: Jed E. Rose
- ||||| Ztalmy (ganaxolone oral) / Marinus
New P2 trial: Ganaxolone Treatment in Children With Fragile X Syndrome (clinicaltrials.gov) - Nov 8, 2012
P2, N=60, Recruiting, Sponsor: Marinus Pharmaceuticals