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NCT04693533 · ClinicalTrials.gov registry record · Phase 4
Fremanezumab, Migraine and Sleep
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT04693533: Clinical Trial Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT04693533 is a Phase 4 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04693533, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine). This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.
Primary Outcome
This primary outcome measures improvement in sleep quality during the treatment period as compared to the pre-treatment period. Sleep quality will be measured using the Insomnia Severity Index. This index scores requires subjects to answer 7 questions by depicting a number (between 0 and 4 ) that represents best their answer. The scale of the Insomnia Severity Index is 0-28. The total score categories are as follows: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 =
Interventions
- DRUG Fremanezumab Prefilled Syringe [Ajovy]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 4 |
Why NCT04693533 stopped before completion
NCT04693533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Fremanezumab Prefilled Syringe [Ajovy] is the first listed.
NCT04693533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04693533 about?
NCT04693533 is a clinical study titled "Fremanezumab, Migraine and Sleep". The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine). This is a within-person s...
What is the current status of trial NCT04693533?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2021-07-29. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT04693533?
The interventions under investigation include: Fremanezumab Prefilled Syringe [Ajovy] (DRUG).
Who is sponsoring clinical trial NCT04693533?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04693533's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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