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Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
Phase 3 trial testing INP104 in Migraine Headache in 360 participants. Completed in 17 March 2020.
| Lead sponsor | Impel Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 360 |
| Start date | 13 July 2018 |
| Primary completion | 17 March 2020 |
| Estimated completion | 17 March 2020 |
| Sites | 36 locations across United States |
Impel Pharmaceuticals — full company profile →
Adults 18 to 65, any sex, with Migraine Headache. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | 5 | |
| 52-Week Treatment Group | 3 |
Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | 241 | |
| 52-Week Treatment Group | 61 |
Mean change from baseline in Quantitative Scoring Scale for Evaluation of the Nasal Mucosa (QSS-NM) score, reported at designated intervals on study. This scale was scored by otolaryngologists during routine endoscopy of the upper nasal cavity of participants. A minimum score of 0 means no issues were detected. A maximum score of 34 indicates severe issues (worse outcome).
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | 0.2 | ± 1.26 |
| 52-Week Treatment Group | 0.0 | ± 0.62 |
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | 0.2 | ± 1.43 |
| 52-Week Treatment Group | 0.1 | ± 0.91 |
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | 0.1 | ± 0.93 |
| 52-Week Treatment Group | 0.1 | ± 0.78 |
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | 0.1 | ± 0.88 |
| 52-Week Treatment Group | 0.0 | ± 0.79 |
| Group | Value | 95% CI |
|---|---|---|
| 52-Week Treatment Group | -0.1 | ± 0.68 |
| Group | Value | 95% CI |
|---|---|---|
| 52-Week Treatment Group | -0.1 | ± 0.61 |
Mean change from baseline in olfactory function score, assessed using the University of Pennsylvania Smell Identification Test (UPSIT), and reported at designated intervals on study. The UPSIT is a 40 question scratch and sniff test of olfactory function. The minimum score of 0 indicates worst olfactory function, and the maximum score of 40 indicates the highest level of olfactory function detectable by the test.
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | -0.48 | ± 2.690 |
| 52-Week Treatment Group | -0.18 | ± 2.573 |
| Group | Value | 95% CI |
|---|---|---|
| 24-Week Treatment Group | -0.22 | ± 2.270 |
| 52-Week Treatment Group | 0.03 | ± 2.373 |
| Group | Value | 95% CI |
|---|---|---|
| 52-Week Treatment Group | -0.13 | ± 2.930 |
| Group | Value | 95% CI |
|---|---|---|
| 52-Week Treatment Group | -0.80 | ± 2.710 |
Time frame: Week 0 to Week 24 (for the 24-Week Treatment Group) and Week 0 to Week 52 (for the 52-Week Treatment Group). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|---|
| Visual impairment | Eye disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Clavicle fracture | Injury, poisoning and procedural complications | — | — |
| Rib fracture | Injury, poisoning and procedural complications | — | — |
| Status migrainosus | Nervous system disorders | — | — |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — |
| Ovarian mass | Reproductive system and breast disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | 24-Week Treatment Group | 52-Week Treatment Group |
|---|---|---|---|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | — | — |
| Product taste abnormal | Product Issues | — | — |
| Sinusitis | Infections and infestations | — | — |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Olfactory test abnormal | Investigations | — | — |
| Dizziness | Nervous system disorders | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Product package associated injury | Injury, poisoning and procedural complications | — | — |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Ear discomfort | Ear and labyrinth disorders | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Acute sinusitis | Infections and infestations | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Menopause | Social circumstances | — | — |
Most-reported serious reactions: Visual impairment, Intestinal obstruction, Clavicle fracture, Rib fracture, Status migrainosus, Abortion spontaneous, Ovarian mass, Pulmonary embolism.
Data from ClinicalTrials.gov NCT03557333 adverse events section.
This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up period.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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