A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Episodic Migraine in Adult Participants

Episodic Migraine

Change from baseline of monthly migraine days (MMD) Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

Reduction from baseline in MMD of ≥50% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24).], Reduction from baseline in MMD of ≥75% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)], Cumulative number of MMD from Day 1 to Week 24, Change from baseline in MMD of moderate or severe intensity Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24), Change from baseline in MHD of moderate or severe intensity Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24), Reduction from baseline in MHD of moderate or severe intensity of ≥50% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24), Reduction from baseline in MHD of moderate or severe intensity of ≥75% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24), Cumulative number of MHD of moderate to severe intensity from Day 1 to Week 24, Change from baseline in the number of days per month of acute migraine medication intake Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) • Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan, Headache medication over user (yes, no) Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) • defined as a participant with ≥10 days/month if ergotamine, triptan, gepant, ditan, opioid or combination analgesic, or ≥15 days/month if non-opioid analgesic (such as paracetamol, aspirin, NSAID), Use of acute migraine medication (yes, no) Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24), Patient’s Global Impression of Change PGIC score Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24), Improvement from baseline to Week 24 of ≥1 and ≥2 grades in PGIC score At Week 12 and Week 24, Change from baseline in role function restrictive domain of Migraine Specific Quality of Life Questionnaire (MSQ) At Week 12 and Week 24 (MSQ) At Week 12 and Week 24, Change from baseline in total MSQ score At Week 12 and Week 24, Improvement from baseline in MSQ score to the minimally important difference/change MID/MIC at Week 12 and Week 24, Change from baseline in total 6-item Headache Impact Text (HIT-6) score At Week 12 and Week 24, Improvement in HIT-6 score to MID/MIC at Week 12 and Week 24, Change from baseline in SF-12 score at Week 12 and Week 24, Transition from baseline to Chronic migraine status at Week 12 and Week 24 (Weeks 21-24) • Chronic migraine status defined as a participant with ≥15 MHD and ≥8 MMD, Time to onset of effect (first time point post randomisation where MMD is reduced from baseline ≥50%), evaluated for MMD responders and all participants from first time point post randomisation to Week 24, Incidence of Treatment emergent adverse event (TEAEs) From baseline up to Week 24, Percentage of Participants with clinically significant changes in vital signs From baseline up to Week 24, Percentage of participants with clinically significant laboratory parameters (blood chemistry, haematology). From baseline up to Week 24, Treatment-emergence of suicidal ideation/suicidal behaviour from baseline to Week 24, Percentage of participants with antibodies to Dysport® at Week 24, Percentage of participants with neutralising antibodies to Dysport® at Week 24, Change from baseline in the number of MMD over the last 12 weeks prior to Week 24 (Weeks 13-24)

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