A study to evaluate the effects of AMG334 compared to placebo medication in the prophylactic treatment of migraine in adult patients who have already tried other prophylactic migraine treatments unsuccessfully

Phase 1

• Conditions: Migraine Prevention; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002211-18-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-03
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

- Documented history of migraine (with or without aura) for = 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- 4 to 14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening based on retrospective reporting
- <15 days per month of headache symptoms (ie migraine and non-migraine)
- Failed 2 to 4 prior migraine prophylaxis treatments out of the following: Propranolol/metoprolol, topiramate, flunarizine, valproate/divalproex, amitriptyline, venlafaxine, lisinopril, candesartan, locally approved products (e.g. oxeterone or pizotifen)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Older than 50 years of age at migraine onset
- Unable to differentiate migraine from other headaches
- History of cluster headache or hemiplegic migraine headache
- Failed more than 4 prior migraine prophylaxis treatments [as specified in protocol]
- Use of a prophylactic migraine medication within 5 half-lives, or a device or procedure within one month prior to the start of the baseline phase or during the baseline phase
- Prior Botulinum toxin A treatment in the head/neck region (including cosmetic use or other licensed indications for Botox ®) within 4 months
prior to start of or during the baseline phase
- Use of the following for any indication in the 1 month prior to the start of the baseline phase or during the baseline phase:
o ergotamines or triptanes =10 days/month, or
o simple analgesics (NSAIDs, acetaminophen, paracetamol) =15 days/month, or
o opioid- or butalbital-containing analgesics =4 days/month

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified