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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02828020
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE July 7, 2016
First Posted Date  ICMJE July 11, 2016
Results First Submitted Date  ICMJE December 13, 2018
Results First Posted Date  ICMJE January 3, 2019
Last Update Posted Date January 3, 2019
Actual Study Start Date  ICMJE July 22, 2016
Actual Primary Completion Date December 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • 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 severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose [ Time Frame: 2 Hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • 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.
  • 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 determinable sustained pain relief from 2 to 24 hours after initial dose.
  • 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 determinable sustained pain freedom from 2 to 24 hours after initial dose.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose [ Time Frame: 2 to 24 Hours ]
  • Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants with Sustained Pain Relief from 2 to 24 Hours after the Initial Dose [ Time Frame: 2 to 24 Hours ]
  • Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose [ Time Frame: 2 Hours ]
  • Percentage of Participants Satisfied or Extremely Satisfied at 2 Hours after Initial Treatment using the 7-Point Satisfaction with Migraine Treatment Scale [ Time Frame: 2 Hours ]
  • Percentage of Participants with Sustained Pain Freedom from 2 to 48 Hours after Initial Dose [ Time Frame: 2 to 48 Hours ]
  • Percentage of Participants with Sustained Pain Relief from 2 to 48 Hours after the Initial Dose [ Time Frame: 2 to 48 Hours ]
  • Percentage of Participants able to Function Normally at 2 Hours after Initial Treatment using the 4-Point Functional Disability Scale [ Time Frame: 2 Hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Official Title  ICMJE 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
Brief Summary This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine, With or Without Aura
Intervention  ICMJE
  • Drug: Ubrogepant
    50 mg 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.
Study Arms  ICMJE
  • Experimental: Ubrogepant 50 mg
    1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
    Interventions:
    • Drug: Ubrogepant
    • Drug: Placebo-matching Ubrogepant
  • Experimental: Ubrogepant 100 mg
    2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
    Interventions:
    • Drug: Ubrogepant
    • Drug: Placebo-matching Ubrogepant
  • Placebo Comparator: Placebo
    2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
    Intervention: Drug: Placebo-matching Ubrogepant
Publications * Dodick DW, Lipton RB, Ailani J, Lu K, Finnegan M, Trugman JM, Szegedi A. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241. doi: 10.1056/NEJMoa1813049.

*   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: November 22, 2017)
1672
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2016)
1350
Actual Study Completion Date  ICMJE December 14, 2017
Actual Primary Completion Date December 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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, diarrhea 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02828020
Other Study ID Numbers  ICMJE UBR-MD-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Adele Thorpe Allergan
PRS Account Allergan
Verification Date December 2018

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