CLINICAL TRIALS PROFILE FOR UBROGEPANT
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All Clinical Trials for ubrogepant
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02828020 ↗ | Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine | Completed | Allergan | Phase 3 | 2016-07-22 | 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. |
| NCT02867709 ↗ | Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine | Completed | Allergan | Phase 3 | 2016-08-26 | 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. |
| NCT02873221 ↗ | An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine | Completed | Allergan | Phase 3 | 2016-09-13 | This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year. |
| NCT04179474 ↗ | Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine | Completed | Allergan | Phase 1 | 2019-09-26 | This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered. |
| NCT04492020 ↗ | Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants | Recruiting | Allergan | Phase 3 | 2020-08-21 | Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome |
| NCT04818515 ↗ | Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine | Completed | Allergan | Phase 1 | 2021-03-17 | Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments. |
| NCT05125302 ↗ | Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17) | Not yet recruiting | Allergan | Phase 3 | 2021-11-09 | Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, 2 to 24 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. |
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