E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of episodic migraine |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027608 |
E.1.2 | Term | Migraine, unspecified |
E.1.2 | System Organ Class | 100000004852 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic migraine |
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E.2.2 | Secondary objectives of the trial |
EFFICACY
•To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least 50% reduction from baseline in monthly migraine days , in subjects with episodic migraine
• To evaluate the effect of AMG 334 compared to placebo as measured by reduction from baseline in monthly migraine attacks, in subjects with episodic migraine
SAFETY
To evaluate the safety and tolerability of AMG 334 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
There is an optional Pharmacokinetic (PK) Substudy. |
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E.3 | Principal inclusion criteria |
- Adults ≥ 18 to ≤ 60 years of age upon entry into screening
- History of migraine (with or without aura) for ≥ 12 months prior to screening according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening
- Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month (with ≥ 50% of the headache days being migraine days) in each of the 3 months prior to screening |
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E.4 | Principal exclusion criteria |
- Older than 50 years of age at migraine onset
- History of cluster headache or hemiplegic migraine headache
- No therapeutic response with > 2 of the eight medication categories
for prophylactic treatment of migraine after an adequate therapeutic
trial ( refer to criterion 4.2.5 in the protocol).
- Used a prohibited medication, device or procedure prior to the start of
the baseline phase (Refer to Section 6.4 of the protocol for the list of
these excluded treatments and the timeframes prior to the start of the
baseline phase)
- Received botulinum toxin in the head and/or neck region within 6 months prior to the start of the baseline phase
- Taken the following for any indication in any month during the 3 months prior to the start of the baseline phase:
• Ergotamines or triptans on ≥ 10 days per month, or
• Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on ≥ 15 days per month, or
• Opioid- or butalbital-containing analgesics on ≥ 3 days per month
- History or evidence of unstable or clinically significant medical condition including but not limited to the following:
• Chronic pain syndromes (eg, fibromyalgia, chronic back pain,
chronic pelvic pain)
• History of major psychiatric disorder, or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 24 at screening.
- Female subject of childbearing potential who is unwilling to use an
acceptable method of effective contraception during treatment with
investigational product through 12 weeks after the last dose of investigational product if receiving AMG 334 70 mg, and 16 weeks after the last dose of investigational product if receiving AMG 334 140 mg.
- Currently receiving treatment in another investigational device or drug study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase, calculated based on the following: (number of migraine days during the last 4 weeks of the double-blind treatment phase, ie, between weeks 9 and 12) – (number of migraine days during the 4-week baseline phase)
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E.5.2 | Secondary end point(s) |
EFFICACY
• At least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment phase
• Change in monthly migraine attacks from baseline in the last 4 weeks of the 12-week double-blind treatment phase, calculated based on the following: (number of migraine attacks during the last 4 weeks of the double-blind treatment phase, ie, between weeks 9 and 12) – (number of migraine attacks during the 4-week baseline phase)
SAFETY:
• Adverse events
• Clinical laboratory values and vital signs
• Anti-AMG 334 antibodies |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For full details, please refer to the schedule of assessments table" in the protocol. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
placebo-controlled period followed by open label period (see protocol for further details) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Denmark |
Finland |
Germany |
Sweden |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 14 |