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Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral AGN-241689 in Episodic Migraine Prevention

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02848326
First received: July 26, 2016
Last updated: July 3, 2017
Last verified: July 2017
  Purpose
This study will evaluate the safety and tolerability of the following doses of AGN-241689: 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

Condition Intervention Phase
Migraine, With or Without Aura Drug: AGN-241689 Drug: Placebo-matching AGN-241689 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in the Mean Number of Migraine/Probable Migraine Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]

Secondary Outcome Measures:
  • Change from Baseline in the Number of Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  • Percentage of Participants with at Least a 50% Reduction in Migraine/Probable Migraine Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  • Change from Baseline in the Activities of Daily Living (ADL) Domain Score of the ACM-I (Assessment of Chronic Migraine Impact) using a 24 Item Questionnaire [ Time Frame: Baseline, Week 12 ]
  • Percentage of Participants "Satisfied" or "Extremely Satisfied" with Migraine Prevention [ Time Frame: Week 12 ]
  • Change from Baseline in the Number of Triptan Use Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  • Change from Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 using a 6-Question Assessment [ Time Frame: Baseline, Week 12 ]

Estimated Enrollment: 810
Actual Study Start Date: September 6, 2016
Estimated Study Completion Date: December 9, 2017
Estimated Primary Completion Date: November 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
AGN-241689 placebo-matching capsule orally twice daily; in the morning and in the evening for 12 weeks.
Drug: Placebo-matching AGN-241689
Placebo-matching AGN-241689 capsule.
Experimental: AGN-241689 10 mg QD
AGN-241689 10 mg capsule orally once daily (QD) in the morning and one AGN-24689 placebo-matching capsule orally once daily in the evening for 12 weeks.
Drug: AGN-241689
AGN-241689 capsule.
Drug: Placebo-matching AGN-241689
Placebo-matching AGN-241689 capsule.
Experimental: AGN-241689 30 mg QD
AGN-241689 30 mg capsule orally once daily in the morning and one AGN-24689 placebo-matching capsule orally once daily in the evening for 12 weeks.
Drug: AGN-241689
AGN-241689 capsule.
Drug: Placebo-matching AGN-241689
Placebo-matching AGN-241689 capsule.
Experimental: AGN-241689 30 mg BID
AGN-241689 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Drug: AGN-241689
AGN-241689 capsule.
Experimental: AGN-241689 60 mg QD
AGN-241689 60 mg capsule orally once daily in the morning and one AGN-24689 placebo-matching capsule orally in the evening for 12 weeks.
Drug: AGN-241689
AGN-241689 capsule.
Drug: Placebo-matching AGN-241689
Placebo-matching AGN-241689 capsule.
Experimental: AGN-241689 60 mg BID
AGN-241689 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Drug: AGN-241689
AGN-241689 capsule.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has at least a 1-year history of migraine with or without aura
  • Age of the patient at the time of migraine onset < 50 years
  • History of 4 to 14 migraine/probable migraine headache days per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
  • Demonstrated compliance with e-diary

Exclusion Criteria:

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness, hemiplegic migraine, and retinal migraine
  • Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Difficulty distinguishing migraine headache from other headaches
  • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
  • Has a history of hepatitis within previous 6 months
  • Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
  • Pregnant or nursing females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02848326

Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com

  Show 77 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Ludovico Christine Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02848326     History of Changes
Other Study ID Numbers: CGP-MD-01
Study First Received: July 26, 2016
Last Updated: July 3, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on September 19, 2017