Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of Episodic Migraine

ClinicalTrials.gov ID

NCT05264129

Acronym / sponsor ID

TANDEM / M23-072

Conditions

Episodic Migraine

Keywords

Episodic Migraine, Ubrogepant, Atogepant, QULIPTA, UBRELVY

Phase

Phase 4

Study type

Interventional

Recruitment status

Completed

Enrolment

263 participants (actual)

Lead sponsor

AbbVieIndustry (pharma, biotech, devices)

Study start

7 Mar 2022 (actual)

Primary completion

4 Apr 2023 (actual)

Study completion

4 Apr 2023 (actual)

First posted

3 Mar 2022 (actual)

Results

Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events (AEs)

   Time frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

   An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. A treatment-emergent adverse event (TEAE) is an AE that occurs or worsens after receiving investigational study drug.

2. Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator

   Time frame: Up to approximately 28 weeks

   Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.

3. Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator

   Time frame: Up to approximately 24 weeks

   12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

4. Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator

   Time frame: Up to approximately 28 weeks

   PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

5. Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period

   Time frame: Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2

   C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.

6. Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the 4-Week Safety Follow-Up Period

   Time frame: From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days.

   C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 39569702Ailani J, Lipton RB, Blumenfeld AM, Mechtler L, Klein BC, He MY, Smith JH, Trugman JM, de Abreu Ferreira R, Brand-Schieber E. Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study. Headache. 2025 Jun;65(6):1005-1014. doi: 10.1111/head.14871. Epub 2024 Nov 21.
• Related InfoLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

37 sites in 1 country: see every site and its status.