A multicentre, randomised, double-blind, placebo-controlled, dose escalation and dose finding phase II study to evaluate the safety and efficacy of IPN10200 in the prevention of episodic or chronic migraine in adults

Episodic Migraine Chronic Migraine

Percentage of participants experiencing any Adverse Event (AEs) including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interest (AESI) and AE leading to treatment discontinuation [ Time Frame: For step 1: From baseline until end of study at Week 36 ], Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters [ Time Frame: For step 1: At all timepoints post injection until Week 36 ] Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator., Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs [ Time Frame: For step 1: At all timepoints post injection until Week 36 ] Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator., Percentage of participants with clinically significant change from baseline in facial examination [ Time Frame: For step 1: At all timepoints post injection until Week 36 ] Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator., Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings [ Time Frame: For step 1: At all timepoints post injection until Week 36 ], Treatment-emergence of suicidal ideation/suicidal behaviour [ Time Frame: For step 1: At all timepoints post injection until Week 36 ], Percentage of participants with Binding antibodies to IPN10200 [ Time Frame: For step 1: At baseline, Week 4, Week 12 and Week 36. ], Percentage of participants with neutralising antibodies to IPN10200 [ Time Frame: For step 1: At baseline, Week 4, Week 12 and Week 36. ], Change from baseline in the number of Monthly migraine days (MMD)s [ Time Frame: For step 2: At Week 12 (Weeks 9-12). ]

Change from baseline in the number of MMD [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36. ], Change from baseline in the number of Monthly Headache Days (MHD) [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36 ], Change from baseline in the number of moderate/severe MHD [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36 ], Migraine prevention response [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36 ] Migraine prevention response is assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥75% in MMD, Headache prevention response [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36. ] Assessed using two thresholds: by a reduction from baseline of either ≥50% or ≥ 75% in MHD, Change from baseline in the number of days per 4 week period of acute medication use for migraine relief. [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36. ] An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine., The use of acute migraine medication (yes or no) [ Time Frame: For Step 1 and step 2: From Week 1 to Week 36. ] The use of acute migraine medication will be recorded in the daily eDiary., Percentage of participants with Binding antibodies to IPN10200 [ Time Frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36. ], Percentage of participants with neutralising antibodies to IPN10200 [ Time Frame: For step 2 : At baseline, Week 4, Week 12 , Week 24 and Week 36. ]

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