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A Phase 2 Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

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ClinicalTrials.gov Identifier: NCT01952574
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by open-label phase. To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days

Condition or disease Intervention/treatment Phase
Migraine Drug: AMG 334 Drug: Placebo Phase 2

Detailed Description:
Randomized, double-blind, placebo-controlled, parallel-group, multi-center study followed by open-label phase. Adults with a one-year history of episodic migraine and not receiving migraine prophylaxis medication will be randomized to one of three AMG 334 treatment groups or a placebo treatment group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Actual Study Start Date : August 6, 2013
Actual Primary Completion Date : September 25, 2014
Estimated Study Completion Date : November 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AMG 334 Dose Level 1
Lowest dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product
Experimental: AMG 334 Dose Level 2
Middle dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product
Experimental: AMG 334 Dose Level 3
Highest dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product
Placebo Comparator: Placebo
AMG 334 Placebo Comparator
Drug: Placebo
Placebo Comparator
Experimental: AMG 334 Dose Level 4 OLE
Open Label Extension dose of Active AMG 334 Investigational Product
Drug: AMG 334
Investigational Product



Primary Outcome Measures :
  1. Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
    To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic migraine


Secondary Outcome Measures :
  1. Proportion of subjects with at least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment phase [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
    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

  2. Change in monthly migraine attacks from baseline in the last 4 weeks of the 12-week double-blind treatment phase [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
    To evaluate the effect of AMG 334 compared to placebo as measured by reduction from baseline in monthly migraine attacks

  3. Adverse events, clinical laboratory values, electrocardiogram, vital signs, anti-AMG 334 antibodies [ Time Frame: Completion of double-blind treatment phase at 12 weeks and open-label treatment phase and safety follow-up at end of study ]
    To evaluate the safety and tolerability of AMG 334



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of migraine for more than12 months prior to screening
  • Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
  • 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 and during baseline phase
  • Demonstrated at least 80% compliance with the eDiary during baseline phase

Exclusion Criteria:

  • Older than 50 years of age at migraine onset
  • History of cluster headache or basilar or hemiplegic migraine headache
  • Unable to differentiate migraine from other headaches
  • No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:

    • Category 1: Divalproex sodium, sodium valproate
    • Category 2: Topiramate
    • Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
    • Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
    • Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
    • Category 6: Flunarizine, verapamil
    • Category 7: Lisinopril, candesartan
    • Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)
  • Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952574


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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01952574     History of Changes
Other Study ID Numbers: 20120178
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Amgen:
migraine, headache, prevention, prophylaxis

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases