ZX008-1900 An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome Brief summary This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy Medical Condition Dravet Syndrome Min. Age 2 Years Max. Age - Who Can Join? All Status Active, not recruiting Inclusion criteria - Male or nonpregnant, nonlactating female - Satisfactory completion of a core study - Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008 - Subject’s caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability Exclusion criteria - Current cardiac valvulopathy or pulmonary hypertension that is clinically significant - Moderate or severe hepatic impairment - Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008 - Study Medication Description Study Medication: N/A Other Descriptive Name: N/A Placebo No Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates April 2019 Actual Start Date of Enrollment July 2025 Planned Study Completion Date General Information Study ID: ZX008-1900 EudraCT Number: 2019-001331-31 CT.gov Number: NCT03936777 Phase: Phase 3 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? Just contact us Austria UCBCares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium UCBCares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) www.ucbcares.be Bulgaria UCBCares.BG@ucb.com +359 2 962 9933 www.ucbcares.bg Canada +1 866 709 8444 Czech Republic UCBCares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) www.ucbcares.cz Denmark UCBCares.DK@ucb.com +45 32462480 80 253827 (freephone) www.ucbcares.dk Finland UCBCares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) www.ucbcares.fi France UCBCares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) www.ucbcares.fr Germany UCBCares.DE@ucb.com +49 2173 48 48 48 www.ucbcares.de Greece UCBCares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) www.ucbcares.gr Hungary UCBCares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) www.ucbcares.hu Ireland UCBCares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) www.ucbcares.co.uk Italy UCBCares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) www.ucbcares.it Japan https://ucbcares.jp Luxemburg UCBCares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway UCBCares.NO@ucb.com +45 32462482 800-10101 (freephone) www.ucbcares.no Poland UCBCares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) www.ucbcares.pl Portugal UCBCares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia UCBCares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) www.ucbcares.sk Spain UCBCares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) www.ucbcares.es Sweden UCBCares.SE@ucb.com +45 32462481 0200 898 671 (freephone) www.ucbcares.se Switzerland +41 58 822 3180 The Netherlands UCBCares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) www.ucbcares.nl UK UCBCares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) www.ucbcares.co.uk USA UCBCares@ucb.com +1-844-599-2273 www.ucb-usa.com/Patients/Patients Email Print Back to results
