CLINICAL TRIALS PROFILE FOR QULIPTA
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All Clinical Trials for QULIPTA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05216263 ↗ | Study of Oral Atogepant Tablets When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine | Not yet recruiting | Allergan | Phase 3 | 2022-03-15 | Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 125 adult participants will be enrolled at approximately 25 sites in the United States. All participants will receive atogepant oral tablet once daily during the 24-week treatment 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 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. |
| NCT05264129 ↗ | Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine | Not yet recruiting | Allergan | Phase 4 | 2022-04-01 | Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of EM. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. 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. |
| NCT05707949 ↗ | Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine | Not yet recruiting | AbbVie | Phase 3 | 2023-03-09 | A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with episodic migraine. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, open-label study of atogepant in participants with a history of episodic migraine. Participants must have completed participation in another study of atogepant (lead-in study) or completed the screening period of that study. Participants must have 4 to 14 migraine days and less than 15 headache days in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 250 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. |
| NCT05711394 ↗ | A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine | Not yet recruiting | AbbVie | Phase 3 | 2023-02-23 | A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. |
| NCT05748483 ↗ | Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events and Disease Activity in Adult Participants With Migraine | Not yet recruiting | AbbVie | Phase 3 | 2023-06-30 | A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment), safety, and efficacy (whether treatment works to prevent migraine symptoms) of atogepant compared to topiramate in patients with migraine. Atogepant is a medicine currently approved in the United States, Canada and Israel for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. 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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires. |
| NCT05861427 ↗ | Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine | Not yet recruiting | AbbVie | Phase 3 | 2023-05-30 | A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 45 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. 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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires. |
| NCT05892757 ↗ | Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers | Not yet recruiting | AbbVie | Phase 1 | 2023-06-30 | This study will assess adverse events and compare how ubrogepant and atogepant tablets move through the body of healthy adult lactating female participants. Ubrogepant and atogepant are approved drugs for treatment of migraine in adults. Participants will be assigned to one of the 2 treatment arms to receive atogepant or ubrogepant. Approximately 24 healthy adult lactating female participants will be enrolled at 3 sites in the United States Participants will receive oral tablets of ubrogepant or atogepant on Day 1 and will be followed for 30 days. |
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