Actively Recruiting
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Led by UCB Biopharma SRL · Updated on 2026-04-27
350
Participants Needed
183
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
CONDITIONS
Official Title
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 12 years of age or older at the Baseline/Randomization Visit
- Participant must have a study caregiver 18 years of age or older at the Screening Visit who is a relative, partner, friend, legally authorized representative, or daily caregiver able to recognize and observe seizures
- Participants must have an established diagnosis of focal, generalized, or combined epilepsy with documented stereotypical prolonged seizure episodes including at least one of: generalized seizures lasting 5 minutes or more, focal seizures lasting 3 minutes or more, or focal/myoclonic seizures followed by generalized tonic-clonic seizures lasting at least 3 minutes
- Participant must have experienced at least 4 stereotypical prolonged seizure episodes in the past 6 months, with the last 2 episodes occurring within 3 months prior to Screening
- Participant must have a brain CT or MRI within 5 years before Screening confirming no progressive neurological disorder
- Participant must be on a stable antiseizure medication regimen for at least 30 days prior to Screening (dose adjustments allowed except for benzodiazepines)
- Male participants must agree to use contraception during treatment and for 7 days after IMP administration and avoid sperm donation during this time
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and for 30 days after IMP administration
- Participant must be capable of giving signed informed consent or assent
- Participant's caregiver(s) must be capable of giving signed informed consent
You will not qualify if you...
- History of alcohol or drug use disorder within the past year
- Known hypersensitivity to the investigational drug, placebo components, or albuterol
- Diagnosis of atrial fibrillation or mitral stenosis
- Convulsive status epilepticus within 8 weeks before Screening
- Presence of nonepileptic seizures that cannot be distinguished from epileptic seizures
- Significant airway hypersensitivity or acute respiratory symptoms
- Chronic pulmonary disease other than mild asthma, or recent serious respiratory infections
- Acute narrow-angle glaucoma
- Conditions contraindicating oral alprazolam use (e.g., myasthenia gravis, severe respiratory insufficiency, sleep apnea syndrome)
- History or risk factors for long QT syndrome or significant ECG abnormalities
- Chronic use of benzodiazepines exceeding allowed duration
- Use of strong CYP3A4 inhibitors or chronic use of opioids, sedative hypnotics, or nonselective beta blockers
- Major psychiatric disorder requiring major treatment changes
- Recent vagal nerve stimulation treatment or setting changes
- Clinically significant lab abnormalities or oxygen saturation below study thresholds
- Positive drug abuse screen at Screening
- Blood pressure or heart rate outside specified ranges after rest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 183 locations
1
Ep0162 50506
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
Ep0162 50720
Scottsdale, Arizona, United States, 85254
Actively Recruiting
3
Ep0162 50494
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Ep0162 50118
Downey, California, United States, 90242
Actively Recruiting
5
Ep0162 50416
La Jolla, California, United States, 92037
Actively Recruiting
6
Ep0162 50702
Long Beach, California, United States, 90806
Actively Recruiting
7
Ep0162 50505
Los Angeles, California, United States, 90095
Withdrawn
8
Ep0162 50492
Orange, California, United States, 92868
Completed
9
Ep0162 50722
Poway, California, United States, 92064
Actively Recruiting
10
Ep0162 50716
Sacramento, California, United States, 95817
Actively Recruiting
11
Ep0162 50367
New Haven, Connecticut, United States, 06519
Completed
12
Ep0162 50088
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
13
Ep0162 50721
Boca Raton, Florida, United States, 33486
Actively Recruiting
14
Ep0162 50515
Gulf Breeze, Florida, United States, 32561
Completed
15
Ep0162 50508
Jacksonville, Florida, United States, 32209-6533
Actively Recruiting
16
Ep0162 50342
Jacksonville, Florida, United States, 32224-1865
Actively Recruiting
17
Ep0162 50199
Miami, Florida, United States, 33136
Actively Recruiting
18
Ep0162 50676
Miami, Florida, United States, 33176
Actively Recruiting
19
Ep0162 50509
Orlando, Florida, United States, 32806
Completed
20
Ep0162 50703
Rockledge, Florida, United States, 32955
Actively Recruiting
21
Ep0162 50308
Tampa, Florida, United States, 33606
Actively Recruiting
22
Ep0162 50323
Honolulu, Hawaii, United States, 96817
Actively Recruiting
23
Ep0162 50512
Boise, Idaho, United States, 83702
Actively Recruiting
24
Ep0162 50493
Chicago, Illinois, United States, 60611
Actively Recruiting
25
Ep0162 50375
Springfield, Illinois, United States, 62702
Actively Recruiting
26
Ep0162 50504
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
27
Ep0162 50561
Lexington, Kentucky, United States, 40536
Withdrawn
28
Ep0162 50395
New Orleans, Louisiana, United States, 70121
Withdrawn
29
Ep0162 50517
New Orleans, Louisiana, United States, 70122
Actively Recruiting
30
Ep0162 50093
Baltimore, Maryland, United States, 21287
Withdrawn
31
Ep0162 50488
Bethesda, Maryland, United States, 20817
Withdrawn
32
Ep0162 50615
Boston, Massachusetts, United States, 02118
Actively Recruiting
33
Ep0162 50047
Boston, Massachusetts, United States, 02215
Completed
34
Ep0162 50110
Ann Arbor, Michigan, United States, 48109
Completed
35
Ep0162 50507
St Louis, Missouri, United States, 63110
Actively Recruiting
36
Ep0162 50499
Las Vegas, Nevada, United States, 89128
Withdrawn
37
Ep0162 50626
Neptune City, New Jersey, United States, 07753
Actively Recruiting
38
Ep0162 50299
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
39
Ep0162 50497
Buffalo, New York, United States, 14221
Actively Recruiting
40
Ep0162 50625
New Hyde Park, New York, United States, 11042
Actively Recruiting
41
Ep0162 50298
New York, New York, United States, 10016
Actively Recruiting
42
Ep0162 50490
New York, New York, United States, 10029
Actively Recruiting
43
Ep0162 50518
New York, New York, United States, 10075
Actively Recruiting
44
Ep0162 50034
Rochester, New York, United States, 14642
Actively Recruiting
45
Ep0162 50514
Charlotte, North Carolina, United States, 28204
Actively Recruiting
46
Ep0162 50487
Charlotte, North Carolina, United States, 28207
Withdrawn
47
Ep0162 50715
Durham, North Carolina, United States, 27705
Actively Recruiting
48
Ep0162 50371
Akron, Ohio, United States, 44308
Withdrawn
49
Ep0162 50528
Cleveland, Ohio, United States, 44195
Withdrawn
50
Ep0162 50724
Portland, Oregon, United States, 97227
Completed
51
Ep0162 50510
Portland, Oregon, United States, 97239-3098
Withdrawn
52
Ep0162 50701
Portland, Oregon, United States, 97239
Actively Recruiting
53
Ep0162 50096
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
54
Ep0162 50364
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
55
Ep0162 50089
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
56
Ep0162 50511
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
57
Ep0162 50491
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
58
Ep0162 50700
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
59
Ep0162 50513
Memphis, Tennessee, United States, 38103-2800
Actively Recruiting
60
Ep0162 50103
Nashville, Tennessee, United States, 37232
Actively Recruiting
61
Ep0162 50731
Austin, Texas, United States, 78749
Actively Recruiting
62
Ep0162 50714
Houston, Texas, United States, 77030
Actively Recruiting
63
Ep0162 50525
Houston, Texas, United States, 77459
Actively Recruiting
64
Ep0162 50496
Round Rock, Texas, United States, 78681
Withdrawn
65
Ep0162 50473
Salt Lake City, Utah, United States, 84132
Actively Recruiting
66
Ep0162 50726
Winchester, Virginia, United States, 22601
Actively Recruiting
67
Ep0162 30016
Fitzroy, Australia
Actively Recruiting
68
Ep0162 30030
Herston, Australia
Actively Recruiting
69
Ep0162 30027
Melbourne, Australia
Withdrawn
70
Ep0162 30031
South Brisbane, Australia
Active, Not Recruiting
71
Ep0162 40650
Blagoevgrad, Bulgaria
Actively Recruiting
72
Ep0162 40708
Pazardzhik, Bulgaria
Actively Recruiting
73
Ep0162 40665
Pleven, Bulgaria
Completed
74
Ep0162 40709
Pleven, Bulgaria
Actively Recruiting
75
Ep0162 40651
Sofia, Bulgaria
Completed
76
Ep0162 20128
Beijing, China
Withdrawn
77
Ep0162 20246
Beijing, China
Actively Recruiting
78
Ep0162 20268
Beijing, China
Completed
79
Ep0162 20299
Beijing, China
Actively Recruiting
80
Ep0162 20261
Changchun, China
Actively Recruiting
81
Ep0162 20133
Chengdu, China
Actively Recruiting
82
Ep0162 20137
Chengdu, China
Actively Recruiting
83
Ep0162 20250
Chongqing, China
Withdrawn
84
Ep0162 20334
Chongqing, China
Actively Recruiting
85
Ep0162 20179
Fuzhou, China
Actively Recruiting
86
Ep0162 20124
Guangzhou, China
Actively Recruiting
87
Ep0162 20260
Guangzhou, China
Completed
88
Ep0162 20264
Guangzhou, China
Completed
89
Ep0162 20269
Guangzhou, China
Actively Recruiting
90
Ep0162 20300
Guangzhou, China
Actively Recruiting
91
Ep0162 20022
Hangzhou, China
Actively Recruiting
92
Ep0162 20320
Kunming, China
Actively Recruiting
93
Ep0162 20258
Lanzhou, China
Actively Recruiting
94
Ep0162 20253
Nanchang, China
Withdrawn
95
Ep0162 20267
Nanjing, China
Actively Recruiting
96
Ep0162 20331
Nanning, China
Actively Recruiting
97
Ep0162 20333
Qingdao, China
Actively Recruiting
98
Ep0162 20123
Shanghai, China
Withdrawn
99
Ep0162 20292
Shanghai, China
Actively Recruiting
100
Ep0162 20332
Shenzhen, China
Withdrawn
101
Ep0162 20289
Shijiazhuang, China
Actively Recruiting
102
Ep0162 20119
Suzhou, China
Actively Recruiting
103
Ep0162 20257
Tianjin, China
Actively Recruiting
104
Ep0162 20025
Wenzhou, China
Actively Recruiting
105
Ep0162 20252
Wuhan, China
Withdrawn
106
Ep0162 20255
Yinchuan, China
Withdrawn
107
Ep0162 20262
Zhanjiang, China
Actively Recruiting
108
Ep0162 20251
Zhengzhou, China
Actively Recruiting
109
Ep0162 40670
Brno, Czechia
Actively Recruiting
110
Ep0162 40672
Ostrava - Poruba, Czechia
Actively Recruiting
111
Ep0162 40063
Prague, Czechia
Completed
112
Ep0162 40671
Prague, Czechia
Actively Recruiting
113
Ep0162 40714
Prague, Czechia
Actively Recruiting
114
Ep0162 40681
Bron, France
Actively Recruiting
115
Ep0162 40688
Bron, France
Withdrawn
116
Ep0162 40680
Dijon, France
Actively Recruiting
117
Ep0162 40130
Marseille, France
Withdrawn
118
Ep0162 40019
Paris, France
Actively Recruiting
119
Ep0162 40682
Paris, France
Actively Recruiting
120
Ep0162 40201
Rennes, France
Actively Recruiting
121
Ep0162 40199
Strasbourg, France
Actively Recruiting
122
Ep0162 40577
Aachen, Germany
Withdrawn
123
Ep0162 40683
Berlin, Germany
Actively Recruiting
124
Ep0162 40685
Bielefeld, Germany
Actively Recruiting
125
Ep0162 40023
Erlangen, Germany
Actively Recruiting
126
Ep0162 40645
Frankfurt am Main, Germany
Actively Recruiting
127
Ep0162 40689
Kehl-kork, Germany
Actively Recruiting
128
Ep0162 40529
Marburg, Germany
Actively Recruiting
129
Ep0162 40724
München, Germany
Actively Recruiting
130
Ep0162 40666
Balassagyarmat, Hungary
Actively Recruiting
131
Ep0162 40673
Budapest, Hungary
Actively Recruiting
132
Ep0162 40704
Budapest, Hungary
Actively Recruiting
133
Ep0162 40653
Debrecen, Hungary
Actively Recruiting
134
Ep0162 40690
Catanzaro, Italy
Withdrawn
135
Ep0162 40674
Genova, Italy
Actively Recruiting
136
Ep0162 40144
Milan, Italy
Actively Recruiting
137
Ep0162 40477
Pavia, Italy
Actively Recruiting
138
Ep0162 40257
Roma, Italy
Actively Recruiting
139
Ep0162 40675
Roma, Italy
Actively Recruiting
140
Ep0162 20248
Fukuoka, Japan
Actively Recruiting
141
Ep0162 20070
Hachioji-shi, Japan
Actively Recruiting
142
Ep0162 20237
Hamamatsu, Japan
Withdrawn
143
Ep0162 20249
Hiroshima, Japan
Actively Recruiting
144
Ep0162 20236
Hōfu, Japan
Actively Recruiting
145
Ep0162 20239
Itami, Japan
Actively Recruiting
146
Ep0162 20143
Kodaira, Japan
Actively Recruiting
147
Ep0162 20315
Koshi-shi, Japan
Actively Recruiting
148
Ep0162 20147
Kyoto, Japan
Actively Recruiting
149
Ep0162 20243
Nagakute, Japan
Actively Recruiting
150
Ep0162 20235
Nagoya, Japan
Actively Recruiting
151
Ep0162 20238
Niigata, Japan
Actively Recruiting
152
Ep0162 20302
Osaka, Japan
Actively Recruiting
153
Ep0162 20241
Ōmura, Japan
Actively Recruiting
154
Ep0162 20316
Sapporo, Japan
Actively Recruiting
155
Ep0162 20337
Shimotsuga-gun, Japan
Actively Recruiting
156
Ep0162 20297
Shinjuku-ku, Japan
Actively Recruiting
157
Ep0162 20240
Shizuoka, Japan
Actively Recruiting
158
Ep0162 20242
Suita, Japan
Actively Recruiting
159
Ep0162 20266
Tōon, Japan
Actively Recruiting
160
Ep0162 20244
Yamagata, Japan
Actively Recruiting
161
Ep0162 40707
Bydgoszcz, Poland
Actively Recruiting
162
Ep0162 40677
Gdansk, Poland
Actively Recruiting
163
Ep0162 40219
Krakow, Poland
Withdrawn
164
Ep0162 40502
Krakow, Poland
Completed
165
Ep0162 40842
Krakow, Poland
Actively Recruiting
166
Ep0162 40676
Lublin, Poland
Actively Recruiting
167
Ep0162 40091
Nowa Sól, Poland
Actively Recruiting
168
Ep0162 40153
Poznan, Poland
Withdrawn
169
Ep0162 40678
Świdnik, Poland
Actively Recruiting
170
Ep0162 40160
Barcelona, Spain
Actively Recruiting
171
Ep0162 40157
L'Hospitalet de Llobregat, Spain
Actively Recruiting
172
Ep0162 40540
Madrid, Spain
Actively Recruiting
173
Ep0162 40352
Pamplona, Spain
Actively Recruiting
174
Ep0162 40668
Seville, Spain
Actively Recruiting
175
Ep0162 40453
Terrassa, Spain
Actively Recruiting
176
Ep0162 40230
Valencia, Spain
Actively Recruiting
177
Ep0162 40667
Valladolid, Spain
Completed
178
Ep0162 40686
Birmingham, United Kingdom
Actively Recruiting
179
Ep0162 40300
Cardiff, United Kingdom
Withdrawn
180
Ep0162 40735
Glasgow, United Kingdom
Actively Recruiting
181
Ep0162 40833
London, United Kingdom
Actively Recruiting
182
Ep0162 40163
Oxford, United Kingdom
Actively Recruiting
183
Ep0162 40108
Salford, United Kingdom
Actively Recruiting
Research Team
U
UCB Cares
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here