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OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01920945
Recruitment Status : Terminated (Difficult enrollment)
First Posted : August 12, 2013
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Brief Summary:
The purpose of this study is to evaluate the effect of BOTOX® (OnabotulinumtoxinA) on the number of headache days in patients with New Daily Persistent Headache (NDPH). NDPH is a benign form of chronic daily headache that comes in two forms: one that resolves on its own after months to years, or one that is difficult to treat and does not respond to preventive or abortive medications. Some patients experience migrainous features such as nausea, vomiting, photophobia, or phonophobia. BOTOX®, a treatment approved for chronic migraine, will be injected into specific muscles of the head and neck area by your study doctor, to evaluate its effectiveness in reducing or relieving NDPH days or severity. BOTOX has not been approved for NDPH and this is the first time it will be used for treatment of NDPH. All participants in this study will only receive BOTOX® and no other study drug.

Condition or disease Intervention/treatment Phase
New Daily Persistent Headache Drug: OnabotulinumtoxinA Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OnabotulinumtoxinA for the Treatment of New Daily Persistent Headache: an Open Label Study
Study Start Date : September 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: OnabotulinumtoxinA Drug: OnabotulinumtoxinA
155 units of OnabotulinumtoxinA, will be injected into 31 sites in the head and neck every 12 weeks for a total of 24 weeks using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections will be divided across seven specific head/neck muscle areas (corrugator, procerus, frontalis, temporalis, suboccipital, splenius capitus and medial/lateral occipital, and trapezius).
Other Name: Botox

Primary Outcome Measures :
  1. change from baseline in frequency of headache days [ Time Frame: 29 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects aged 18 or older, male or female of any race with the diagnosis of NDPH meeting International Classification of Headache Disorders (ICHD-2) criteria will be included in the study. The criteria is as follows:

A. Persistent headache fulfilling criteria B and C B. Distinct and clearly remembered onset, with pain becoming continuous and unremitting within 24 hours C. Present for >3 months D. Not better accounted for by another ICHD-3 diagnosis

Exclusion Criteria:

  1. Those with relevant physical or psychological illness, particularly conditions that might put them at risk if exposed to OnabotulinumtoxinA (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other neuromuscular disease).
  2. Diagnosis of other primary/secondary headache disorder.
  3. Psychiatric disorders that could interfere with study participation.
  4. Subjects who abuse drugs, including headache treatments and alcohol (DSM IV criteria).
  5. Those allergic to compounds similar to the study medication.
  6. Those who are pregnant or breastfeeding, or who do not use adequate contraceptive methods.
  7. Those who have had any prior exposure to any botulinum toxin serotype.

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 identifier (NCT number): NCT01920945

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United States, New York
Roosevelt Hospital Headache Institute
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
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Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT01920945    
Other Study ID Numbers: ALLERGAN-13-002
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents