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NCT01071096 · ClinicalTrials.gov registry record · Phase 4
Calcitonin Gene-related Peptide Levels in Chronic Migraine
A Phase 4 study of Chronic Migraine, sponsored by Cady, Roger, M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT01071096: Completed Phase 4 study of Chronic Migraine, sponsored by Cady, Roger, M.D..
NCT01071096 is a Phase 4 study of Chronic Migraine that has completed, run by Cady, Roger, M.D.. The registered enrollment target is 20 participants, below the 342-participant average among 17 other Chronic Migraine trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01071096, a Phase 4 study of Chronic Migraine, has completed, sponsored by Cady, Roger, M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP) levels in saliva following treatment with OnabotulinumtoxinA versus saline. Eligible patients will be randomized and receive injections of OnabotulinumtoxinA or Saline at Visit 1. Following 3 months plus a 1 month wash out, patients will receive cross-over injections at Visit 5. Patients will return for monthly visits and exit the study at Visit 8. Patients will collect saliva at monthly intervals and document in a daily headache diary throughout the study .
Primary Outcome
Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.
Conditions Studied
Interventions
- DRUG Saline
- DRUG OnabotulinumtoxinA
Study Locations (2)
Missouri
- Clinvest - Springfield
New York
- Island Neurological Associates, P.C. - Plainview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT01071096 record still lists
NCT01071096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 342-participant average among 17 other Chronic Migraine trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Chronic Migraine appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT01071096 reports a single indexed study location in Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT01071096 about?
NCT01071096 is a clinical study titled "Calcitonin Gene-related Peptide Levels in Chronic Migraine". Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP) levels in saliva following treatment with OnabotulinumtoxinA versus saline. Eligible patients will be randomized and re...
What is the current status of trial NCT01071096?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2010-06. Estimated completion is 2011-06.
What conditions does trial NCT01071096 study?
This clinical trial studies the following conditions: Chronic Migraine.
What interventions are being tested in trial NCT01071096?
The interventions under investigation include: Saline (DRUG), OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT01071096?
This trial is sponsored by Cady, Roger, M.D., which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01071096 being conducted?
This trial has 2 study locations across Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01071096's enrollment target sits among peer trials
20 18th of 17 the lowest of 17 other Chronic Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Migraine 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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