STOP 301: Open-label Safety and Tolerability of Chronic Intermittent Usage for 24/52 Weeks of INP104 [Nasal DHE Administered by POD Device] in Migraine
Poster presented at International Headache Congress (IHC) 2019 in Dublin, Ireland
Authors: Stephen B. Shrewsbury, Maria Jeleva, Jasna Hocevar-Trnka, Meghan Swardstrom
1) Establish safety and tolerability of repeated INP104 exposure 2) Explore efficacy of INP104 in migraineurs (compared to baseline) 3) Explore INP104 effects on Quality of Life and Healthcare Utilisation during the 24/52 weeks.
~300 patients will enter the 24-week study, with ~80 enrolling into a further 28-week treatment period. Main inclusion criteria: 18 to 65 years; migraine with or without aura, ³2 attacks/month for previous 6 months; >80% e-dairy compliance; contracepting. Main exclusion criteria: trigeminal autonomic cephalalgias; migraine aura without headache, hemiplegic migraine or migraine with brainstem aura; chronic migraines, medication overuse headache or other chronic headache syndromes; status
migrainosus; coronary artery disease (CAD) or significant risk of CAD; abnormal, clinically significant laboratory tests at screening; recent acute illness or uncontrolled infection; recurrent sinusitis or epistaxis; significant pre-existing nasal disease or upper space mucosal abnormality; excessive triptan or ergot use; significant use of barbiturates or opiates in 2 months prior or during screening. All subjects will have extensive migraine history, healthcare utilization and quality of life assessments conducted during screening and treatment response recorded in an e-diary. Olfactory mucosal integrity and function will be collected by endoscopy of the upper
(and lower) nasal spaces and by University of Pennsylvania Smell Identification Test (UPSIT) at intervals.
As a result of the strategic considerations and to achieve the objectives of the study, the study design was formulated (see
STOP 301 is designed to assess safety, tolerability and explore efficacy of repeat administration of DHE drug to the
upper nasal space.
Shrewsbury SB, Jeleva M, Hocevar-Trnka J and Swardstrom M. STOP 301: Open-label Safety and Tolerability of Chronic Intermittent Usage for 24/52 Weeks of INP104 [Nasal Dihydroergotamine Mesylate (DHE) Administered by Precision Olfactory Delivery (PODTM) Device] in Migraine Headache IHC 2019 Abstracts. (2019). Cephalalgia, 39(1_suppl), 208-209. https://doi.org/10.1177/0333102419859835