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

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ClinicalTrials.gov Identifier: NCT02848326
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: AGN-241689 Drug: Placebo-matching AGN-241689 Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
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
Actual Study Start Date : September 6, 2016
Estimated Primary Completion Date : March 28, 2018
Estimated Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Change from Baseline in the Number of Headache Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  2. 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 ]
  3. 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 ]
  4. Percentage of Participants "Satisfied" or "Extremely Satisfied" with Migraine Prevention [ Time Frame: Week 12 ]
  5. Change from Baseline in the Number of Triptan Use Days [ Time Frame: Baseline, Last 28 days of the treatment period ending with Week 12 ]
  6. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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): NCT02848326


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

  Show 82 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
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

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