7 completed, 1 terminated, 1 withdrawn. 6 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Terminated 1, Withdrawn 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of DESF in Pediatric Subjects DESF - Allergic Reaction | Phase 1 | Completed | Aquestive Therapeutics | 32 | 2024-12-26 | 2026-07-15 |
| Pharmacokinetics Study of DESF in Adults With Oral Allergy Syndrome DESF, Epinephrine Injection - Allergic Reaction | Phase 2 | Completed | Aquestive Therapeutics | 36 | 2024-07-17 | 2025-09-26 |
| Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study Diazepam Buccal Film, Diastat® Rectal Gel (Valeant Pharmaceuticals USA) - Epilepsy | Phase 1 / Phase 2 | Completed | Aquestive Therapeutics | 31 | 2019-04-13 | 2020-08-18 |
| Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS) Riluzole Oral Soluble film (ROSF) 50 mg - Amyotrophic Lateral Sclerosis | Phase 2 | Terminated | Aquestive Therapeutics | 9 | 2018-04-04 | 2020-08-18 |
| Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis Riluzole Oral Soluble Film - ALS | Phase 2 | Withdrawn | Aquestive Therapeutics | 2018-03-01 | 2019-05-13 | |
| Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category - Epilepsy | Phase 3 | Completed | Aquestive Therapeutics | 149 | 2018-01-23 | 2021-08-05 |
| Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy Diazepam Buccal Film - Epilepsy | Phase 2 | Completed | Aquestive Therapeutics | 24 | 2017-08-31 | 2021-05-26 |
| Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy Diazepam Buccal Film 12.5 mg - Epilepsy | Phase 2 | Completed | Aquestive Therapeutics | 35 | 2017-05-25 | 2020-09-18 |
| Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water, Zofran ODT (ondansetron 8 mg) without water - Healthy Participants | Phase 1 | Completed | Aquestive Therapeutics | 18 | 2008-08-01 | 2020-08-18 |
Epilepsy (4) · Amyotrophic Lateral Sclerosis (2) · Hypersensitivity (2) · Seizures (1)
Diagnosis-Related Groups (1) · Epinephrine (1) · Ondansetron (1) · Water (1)
United States (8) · Canada (1)
Gary Slatko (3) · Cassie Jung (1) · Emily Plowman, PhD, CCC-SLP (1) · Frank Lee, MD (1) · Gary Slatko, MD (1) · James Wymer, MD, PhD (1) · Sudershan Vishwanath, MD (1)