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A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies (LIBERTY)

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ClinicalTrials.gov Identifier: NCT03096834
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE March 30, 2017
Last Update Posted Date December 6, 2021
Actual Study Start Date  ICMJE March 20, 2017
Actual Primary Completion Date January 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
Percentage of patients with a 50% response in the reduction of Monthly Migraine Days (MMD) [ Time Frame: The last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
Assessed via patient report collected in the headache e-diary.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • Change in the number of monthly migraine days (MMDs) from baseline to month 3 [ Time Frame: Baseline, the last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
  • Change in the Migraine Physical Function Impact Diary (MPFID) "impact on everyday activities" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
  • Change in the MPFID "physical impairment" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
  • Change in the number of monthly acute migraine-specific medication treatment days [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
  • Percentage of patients with a 75% response [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.
  • Percentage of patients with a 100% response [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Official Title  ICMJE A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed Prophylactic Migraine Treatments
Brief Summary The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.
Detailed Description This study is a double blind, placebo-controlled , randomized trial in adult patients with episodic migraine. . A screening period of 2 weeks is used to assess initial eligibility, followed by a 4-week baseline period. After randomization, visits occur at four week intervals until Week 12, which is the End of Treatment. The final visit, is a Safety Follow-Up visit will occur 12 weeks later, at Week 24.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Episodic Migraine
Intervention  ICMJE
  • Biological: AMG334 Pre-Filled Syringe (PFS)
    Subcutaneous injection of AMG 334
  • Biological: Placebo Pre-Filled Syringe (PFS)
    Subcutaneous injection of placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo DB
    Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
    Intervention: Biological: Placebo Pre-Filled Syringe (PFS)
  • Experimental: AMG334 140 mg DB
    AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch
    Intervention: Biological: AMG334 Pre-Filled Syringe (PFS)
  • Experimental: AMG334 140 mg DB cont on AMG334 140 mg
    AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch
    Intervention: Biological: AMG334 Pre-Filled Syringe (PFS)
  • Experimental: Placebo in DB to AMG334 140 mg
    Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
    Intervention: Biological: AMG334 Pre-Filled Syringe (PFS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2021)
246
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2017)
220
Actual Study Completion Date  ICMJE January 28, 2021
Actual Primary Completion Date January 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented history of migraine in the 12 months prior to screen
  • 4-14 days per month of migraine symptoms
  • >=80% diary compliance during the Baseline period
  • Failure of previous migraine prophylactic treatments

Exclusion Criteria:

  • >50 years old at migraine onset
  • Pregnant or nursing
  • History of cluster or hemiplegic headache
  • Evidence of seizure or psychiatric disorder
  • Score of 19 or higher on BDI
  • Active chronic pain syndrome
  • Cardiac or hepatic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT03096834
Other Study ID Numbers  ICMJE CAMG334A2301
2016-002211-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

URL: http://www.clinicalstudydatarequest.com
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP