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4 Diseases |  |
2 Trials |
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2 Trials |  |
76 News |  |
- |||| staccato alprazolam (AZ-002) / UCB
Trial completion date, Trial primary completion date: A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - Aug 30, 2024
P3, N=300, Enrolling by invitation, Sponsor: UCB Biopharma SRL
Trial completion date: May 2026 --> Nov 2028 | Trial primary completion date: May 2026 --> Nov 2028
- ||| staccato alprazolam (AZ-002) / UCB
Trial completion date: A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - Aug 30, 2024
P3, N=250, Recruiting, Sponsor: UCB Biopharma SRL
Trial completion date: May 2026 --> Nov 2028 | Trial primary completion date: May 2026 --> Nov 2028 Trial completion date: Apr 2024 --> Apr 2026
- staccato alprazolam (AZ-002) / UCB
Pulmonary Safety of Staccato (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3247;
P1
Minor decreases in FEV1 from baseline were observed with STAP vs placebo; these were not clinically relevant. Cough was the most common respiratory-TEAE.
- staccato alprazolam (AZ-002) / UCB
Pharmacokinetics of Staccato (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3245;
P1
Cough was the most common respiratory-TEAE. Alprazolam was rapidly absorbed (median Tmax of 1.5
- staccato alprazolam (AZ-002) / UCB
Pharmacokinetics and Tolerability of Single-dose Staccato (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3240;
P1
Alprazolam was rapidly absorbed (median Tmax of 1.5 Alprazolam PK following Staccato
- || staccato alprazolam (AZ-002) / UCB
P1 data, PK/PD data, Journal: Pharmacokinetics of Staccato (Pubmed Central) - Feb 24, 2024
P1
Staccato alprazolam was generally well tolerated and displayed a safety profile consistent with that known from other alprazolam applications. No new safety signals were identified.
- || Review, Journal: New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development. (Pubmed Central) - Aug 21, 2023
The diversity of the current pipeline underscores a strong interest in the GABA system as a target for new treatment development in epilepsy. To date, limited clinical data are available for these investigational treatments and further studies are required to assess their potential value in addressing unmet needs in epilepsy management.
- |||| staccato alprazolam (AZ-002) / UCB
Trial completion date, Trial primary completion date: A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - May 17, 2023
P3, N=250, Recruiting, Sponsor: UCB Biopharma SRL
To date, limited clinical data are available for these investigational treatments and further studies are required to assess their potential value in addressing unmet needs in epilepsy management. Trial completion date: Jul 2023 --> Apr 2024 | Trial primary completion date: Jul 2023 --> Apr 2024
- |||| staccato alprazolam (AZ-002) / UCB
Trial completion date, Trial primary completion date: A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - May 17, 2023
P3, N=300, Enrolling by invitation, Sponsor: UCB Biopharma SRL
Trial completion date: Jul 2023 --> Apr 2024 | Trial primary completion date: Jul 2023 --> Apr 2024 Trial completion date: Aug 2025 --> May 2026 | Trial primary completion date: Aug 2025 --> May 2026
- || staccato alprazolam (AZ-002) / UCB
Trial completion: A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants (clinicaltrials.gov) - Feb 27, 2023
P1, N=21, Completed, Sponsor: UCB Biopharma SRL
Trial completion date: Aug 2025 --> May 2026 | Trial primary completion date: Aug 2025 --> May 2026 Recruiting --> Completed
- || staccato alprazolam (AZ-002) / UCB
Enrollment open: A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants (clinicaltrials.gov) - Jan 23, 2023
P1, N=20, Recruiting, Sponsor: UCB Biopharma SRL
Recruiting --> Completed Not yet recruiting --> Recruiting
- || staccato alprazolam (AZ-002) / UCB
New P1 trial: A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants (clinicaltrials.gov) - Nov 23, 2022
P1, N=20, Not yet recruiting, Sponsor: UCB Biopharma SRL
- || staccato alprazolam (AZ-002) / UCB
P2b data, Journal: A randomized Phase 2b efficacy study in patients with seizure episodes with a predictable pattern using Staccato® alprazolam for rapid seizure termination. (Pubmed Central) - Oct 22, 2022
P2
Both 1.0 mg and 2.0 mg doses of Staccato® alprazolam demonstrated efficacy in rapidly terminating seizures in an inpatient setting and were well tolerated. The next step is a Phase 3 confirmatory study to demonstrate efficacy and safety of Staccato® alprazolam for rapid cessation of seizures in an outpatient setting.
- || staccato alprazolam (AZ-002) / UCB
Trial completion: A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy (clinicaltrials.gov) - Apr 8, 2022
P1, N=14, Completed, Sponsor: UCB Biopharma SRL
The next step is a Phase 3 confirmatory study to demonstrate efficacy and safety of Staccato® alprazolam for rapid cessation of seizures in an outpatient setting. Recruiting --> Completed
- ||| Ztalmy (ganaxolone oral) / Marinus
P2/3 data, Clinical Trial,Phase III, Journal: Epilepsy: Expert opinion on emerging drugs in phase 2/3 clinical trials. (Pubmed Central) - Apr 6, 2022
Novel mechanisms of action involve cholesterol degradation, mitochondrial pathways, anti-inflammation and neuro-regeneration. Earlier identification of genetic conditions through genetic testing will allow for earlier use of disease specific and disease-modifying therapies.
- |||||| staccato alprazolam (AZ-002) / UCB
Enrollment open: A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - Mar 4, 2022
P3, N=250, Enrolling by invitation, Sponsor: UCB Biopharma SRL
Earlier identification of genetic conditions through genetic testing will allow for earlier use of disease specific and disease-modifying therapies. Not yet recruiting --> Enrolling by invitation
- |||||| staccato alprazolam (AZ-002) / UCB
Enrollment open: A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - Jan 6, 2022
P3, N=250, Recruiting, Sponsor: UCB Biopharma SRL
Not yet recruiting --> Enrolling by invitation Not yet recruiting --> Recruiting
- ||| staccato alprazolam (AZ-002) / UCB
Trial completion: A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma (clinicaltrials.gov) - Nov 26, 2021
P1, N=78, Completed, Sponsor: UCB Biopharma SRL
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || staccato alprazolam (AZ-002) / UCB
Enrollment closed: A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma (clinicaltrials.gov) - Nov 24, 2021
P1, N=78, Active, not recruiting, Sponsor: UCB Biopharma SRL
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | staccato alprazolam (AZ-002) / UCB
Trial completion date, Trial primary completion date: A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy (clinicaltrials.gov) - Oct 17, 2021
P1, N=14, Recruiting, Sponsor: UCB Biopharma SRL
Recruiting --> Active, not recruiting Trial completion date: Sep 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Dec 2021
- |||||||| staccato alprazolam (AZ-002) / UCB
New P3 trial: A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - Oct 14, 2021
P3, N=200, Not yet recruiting, Sponsor: UCB Biopharma SRL
- |||||||||| staccato alprazolam (AZ-002) / UCB
New P3 trial: A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (clinicaltrials.gov) - Oct 13, 2021
P3, N=250, Not yet recruiting, Sponsor: UCB Biopharma SRL
- || staccato alprazolam (AZ-002) / UCB
Enrollment change: A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma (clinicaltrials.gov) - May 27, 2021
P1, N=78, Recruiting, Sponsor: UCB Biopharma SRL
Trial completion date: Sep 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Dec 2021 N=30 --> 78
- || staccato alprazolam (AZ-002) / UCB
Trial completion: Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants (clinicaltrials.gov) - May 4, 2021
P1, N=30, Completed, Sponsor: UCB Biopharma SRL
N=30 --> 78 Active, not recruiting --> Completed
- || staccato alprazolam (AZ-002) / UCB
Enrollment open: A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy (clinicaltrials.gov) - May 4, 2021
P1, N=14, Recruiting, Sponsor: UCB Biopharma SRL
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- || staccato alprazolam (AZ-002) / UCB
Enrollment closed: Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants (clinicaltrials.gov) - Apr 29, 2021
P1, N=30, Active, not recruiting, Sponsor: UCB Biopharma SRL
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || staccato alprazolam (AZ-002) / UCB
New P1 trial: A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy (clinicaltrials.gov) - Apr 23, 2021
P1, N=14, Not yet recruiting, Sponsor: UCB Biopharma SRL
- || staccato alprazolam (AZ-002) / UCB
Enrollment open: Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants (clinicaltrials.gov) - Mar 24, 2021
P1, N=30, Recruiting, Sponsor: UCB Biopharma SRL
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || staccato alprazolam (AZ-002) / UCB
New P1 trial: A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma (clinicaltrials.gov) - Mar 17, 2021
P1, N=30, Recruiting, Sponsor: UCB Biopharma SRL
- || staccato alprazolam (AZ-002) / UCB
New P1 trial: Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants (clinicaltrials.gov) - Mar 3, 2021
P1, N=30, Not yet recruiting, Sponsor: UCB Biopharma SRL
- | staccato alprazolam (AZ-002) / UCB
Enrollment change: StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - Feb 3, 2021
P2, N=156, Completed, Sponsor: Engage Therapeutics, Inc.
Not yet recruiting --> Recruiting N=116 --> 156
- staccato alprazolam (AZ-002) / Ferrer International, UCB
[VIRTUAL] A double-blind, placebo-controlled, inpatient, dose-ranging efficacy study of Staccato alprazolam in participants with epilepsy with a predictable seizure pattern: Results from part 2 () - Nov 28, 2020 - Abstract #AES2020AES_1253;
P2
Tx was feasible in most ppts. Seizure cessation data support rapid systemic absorption and onset of clinical activity of STAP.
- ||| staccato alprazolam (AZ-002) / UCB
Trial completion: StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - Oct 19, 2020
P2, N=116, Completed, Sponsor: EngageTherapeutics, Inc.
Seizure cessation data support rapid systemic absorption and onset of clinical activity of STAP. Active, not recruiting --> Completed
- | alprazolam / Generic mfg.
Journal: Inhaled alprazolam rapidly suppresses epileptic activity in photosensitive participants. (Pubmed Central) - Apr 16, 2020
The AE profile of Staccato alprazolam was similar to what has been reported for alprazolam for other indications. The results support further development of Staccato alprazolam as a rescue medication for the acute treatment of seizures.
- staccato alprazolam (AZ-002) / Engage Therap, Ferrer International, alprazolam / Generic mfg.
A Two-Part, Phase 2b Efficacy Study of Staccato® Alprazolam Inhaler in Patients with Epilepsy with a Predictable Seizure Pattern: Topline Results from Part 2 () - Jan 21, 2020 - Abstract #AAN2020AAN_2239;
P2
Treatment of ongoing seizures with STAP or placebo has been feasible. Topline unblinded results are expected in Spring of 2020.
- || staccato alprazolam (AZ-002) / UCB
Enrollment change: Staccato Alprazolam Abuse Liability (clinicaltrials.gov) - Jan 2, 2020
P1, N=31, Completed, Sponsor: Alexza Pharmaceuticals, Inc.
Topline unblinded results are expected in Spring of 2020. N=14 --> 31
- staccato alprazolam (AZ-002) / Engage Therap, Ferrer International, alprazolam / Generic mfg.
A Phase 1 Open-Label, Single-Dose, Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smoker versus Non-Smoker Healthy Adult Participant (Hall E) - Nov 28, 2019 - Abstract #AES2019AES_1202;
Staccato alprazolam was well tolerated in smoker and non-smoker ppts. These results give further support to developing Staccato alprazolam as a rescue treatment for acute epileptic seizures.
- staccato alprazolam (AZ-002) / Engage Therap, Ferrer International, alprazolam / Generic mfg.
A Two-Part, Phase 2b Efficacy Study of Staccato® Alprazolam Inhaler in Patients with Epilepsy with a Predictable Seizure Pattern: Results from Part 1 and Early Results from Part 2 (Hall E) - Nov 28, 2019 - Abstract #AES2019AES_1092;
P2
Conclustions Feasibility of tx of pts with PSPs was demonstrated in Part 1. Enrollment into Part 2 of the study, the double-blind segment, is ongoing with topline data expected in Fall of 2019.
- || staccato alprazolam (AZ-002) / UCB
Enrollment closed: StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - Nov 26, 2019
P2, N=123, Active, not recruiting, Sponsor: EngageTherapeutics, Inc.
Enrollment into Part 2 of the study, the double-blind segment, is ongoing with topline data expected in Fall of 2019. Recruiting --> Active, not recruiting
- || staccato alprazolam (AZ-002) / UCB
Trial completion date, Trial primary completion date: StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - Nov 15, 2019
P2, N=123, Recruiting, Sponsor: EngageTherapeutics, Inc.
Recruiting --> Active, not recruiting Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Aug 2019 --> Dec 2019
- ||| staccato alprazolam (AZ-002) / Engage Therap, Ferrer Internacional
P2b data: Phase 2b StATES trial data on Staccato Alprazolam for acute seizure rescue released at #AANAM (Twitter) - May 5, 2019
- || staccato alprazolam (AZ-002) / UCB
Trial completion date, Trial primary completion date: StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - Mar 21, 2019
P2, N=123, Recruiting, Sponsor: EngageTherapeutics, Inc.
Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Aug 2019 --> Dec 2019 Trial completion date: May 2019 --> Aug 2019 | Trial primary completion date: May 2019 --> Aug 2019
- || staccato alprazolam (AZ-002) / UCB
Trial completion: Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers (clinicaltrials.gov) - Dec 19, 2018
P1, N=36, Completed, Sponsor: EngageTherapeutics, Inc.
Trial completion date: May 2019 --> Aug 2019 | Trial primary completion date: May 2019 --> Aug 2019 Recruiting --> Completed
- | staccato alprazolam (AZ-002) / UCB
New P1 trial: Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers (clinicaltrials.gov) - May 3, 2018
P1, N=36, Recruiting, Sponsor: EngageTherapeutics, Inc.
- | staccato alprazolam (AZ-002) / UCB
New P2 trial: StATES: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (clinicaltrials.gov) - Mar 27, 2018
P2, N=108, Recruiting, Sponsor: EngageTherapeutics, Inc.
- | staccato alprazolam (AZ-002) / UCB
Enrollment change: Staccato Alprazolam in Panic Attack (clinicaltrials.gov) - Jun 16, 2017
P2, N=49, Completed, Sponsor: Alexza Pharmaceuticals, Inc.
Recruiting --> Completed N=40 --> 49
- staccato alprazolam (AZ-002) / UCB
Trial completion, Trial primary completion date: Staccato Alprazolam and Photoparoxysmal Response (clinicaltrials.gov) - Jan 31, 2017
P2, N=5, Completed, Sponsor: Alexza Pharmaceuticals, Inc.
N=40 --> 49 Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Mar 2016
- staccato alprazolam (AZ-002) / UCB
Trial primary completion date: Staccato Alprazolam and Photoparoxysmal Response (clinicaltrials.gov) - Aug 22, 2015
P2, N=6, Recruiting, Sponsor: Alexza Pharmaceuticals, Inc.
Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Mar 2016 Trial primary completion date: Jun 2015 --> Dec 2015
- staccato alprazolam (AZ-002) / UCB
New P2 trial: Staccato Alprazolam and Photoparoxysmal Response (clinicaltrials.gov) - Jan 30, 2015
P2, N=6, Recruiting, Sponsor: Alexza Pharmaceuticals, Inc.