A Study of Eptinezumab in Pediatric Participants With Episodic Migraine (PROSPECT-1)
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| ClinicalTrials.gov Identifier: NCT05897320 |
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Recruitment Status :
Recruiting
First Posted : June 9, 2023
Last Update Posted : May 7, 2024
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Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
- Study Details
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Brief Summary:
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Episodic Migraine | Drug: Eptinezumab Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 315 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine |
| Actual Study Start Date : | June 8, 2023 |
| Estimated Primary Completion Date : | October 31, 2024 |
| Estimated Study Completion Date : | October 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Migraine
MedlinePlus related topics:
Migraine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Eptinezumab 300 mg
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
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Drug: Eptinezumab
Solution for infusion |
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Placebo Comparator: Placebo
Participants will receive a single IV infusion of matching placebo to eptinezumab.
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Drug: Placebo
Solution for infusion |
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Experimental: Eptinezumab 100 mg
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
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Drug: Eptinezumab
Solution for infusion |
Primary Outcome Measures :
- Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
Secondary Outcome Measures :
- Response: ≥50% Reduction From Baseline in MMDs [ Time Frame: Baseline, Weeks 1-4 and Weeks 1-12 ]
- Percentage of Participants with Migraine on the Day After Dosing (Day 1) [ Time Frame: On Day After Dosing ]
- Change From Baseline in MMDs with Acute Medication Use [ Time Frame: Baseline, Weeks 1-12 ]
- Response: ≥75% reduction from baseline in MMDs [ Time Frame: Baseline, Weeks 1-4 and Weeks 1-12 ]
- Change From Baseline in the Number of Monthly Headache Days (MHDs) [ Time Frame: Baseline, Weeks 1-12 ]
- Change From Baseline in Monthly Hours with Headache [ Time Frame: Baseline, Weeks 1-12 ]
- Change From Baseline in Days with Acute Medication [ Time Frame: Baseline, Weeks 1-12 ]
- Change From Baseline in Rate of Migraines with Severe Pain Intensity [ Time Frame: Baseline, Weeks 1-12 ]
- Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score [ Time Frame: Baseline, Week 12 ]
- Free Eptinezumab Plasma Concentrations [ Time Frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20 ]
- Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [ Time Frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20 ]
- Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) [ Time Frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20 ]
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| Ages Eligible for Study: | 6 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
- During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
- During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.
Exclusion Criteria:
- History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
- History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
- Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
Other inclusion and exclusion criteria may apply.
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): NCT05897320
Contacts
| Contact: Email contact via H. Lundbeck A/S | +45 36301311 | LundbeckClinicalTrials@Lundbeck.com |
Locations
Show 28 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT05897320 |
| Other Study ID Numbers: |
19357A 2022-502538-14-00 ( Other Identifier: EU CTR ) |
| First Posted: | June 9, 2023 Key Record Dates |
| Last Update Posted: | May 7, 2024 |
| Last Verified: | May 2024 |
| 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 |