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Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE II)

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ClinicalTrials.gov Identifier: NCT02867709
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : January 29, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Condition or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: Ubrogepant Drug: Placebo-matching Ubrogepant Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : February 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Ubrogepant 25 mg
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Experimental: Ubrogepant 50 mg
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Placebo Comparator: Placebo
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.




Primary Outcome Measures :
  1. Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose [ Time Frame: Baseline (Predose) to 2 hours after initial dose ]
    Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.

  2. Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose [ Time Frame: Baseline (Predose) to 2 hours after initial dose ]
    The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.


Secondary Outcome Measures :
  1. Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose [ Time Frame: Baseline (Predose) to 2 hours after initial dose ]
    Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.

  2. Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose [ Time Frame: 2 to 24 hours after initial dose ]
    Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.

  3. Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose [ Time Frame: 2 to 24 hours after initial dose ]
    Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.

  4. Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose [ Time Frame: 2 hours after initial dose ]
    Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.

  5. Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose [ Time Frame: 2 hours after initial dose ]
    Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.

  6. Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose [ Time Frame: 2 hours after initial dose ]
    Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
  • Migraine onset before age 50
  • History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
  • History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion Criteria:

  • Difficulty distinguishing migraine headache from tension-type other headaches
  • Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
  • Has a chronic non-headache pain condition requiring daily pain medication
  • 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 any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
  • Has a history of hepatitis within previous 6 months.

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): NCT02867709


  Show 109 Study Locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Adele Thorpe Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] May 19, 2017
Statistical Analysis Plan  [PDF] March 21, 2018


Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02867709     History of Changes
Other Study ID Numbers: UBR-MD-02
First Posted: August 16, 2016    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: March 19, 2019
Last Verified: March 2019

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

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