Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by The Research Center of Southern California.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Research Center of Southern California
ClinicalTrials.gov Identifier:
NCT01350375
First received: May 6, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

This study will investigate the therapeutic utility of BOTOX in reducing the degree of Forward Head Posture (FHP) with associated headache and myofascial pain, decreasing the frequency of headache, and improving the overall quality of life.


Condition Intervention Phase
Forward Head Posture With Associated Episodic Headache Disorder
Drug: Botox
Drug: Saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double-Blind Placebo Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Botulinum Neurotoxin Type A in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder

Resource links provided by NLM:


Further study details as provided by The Research Center of Southern California:

Primary Outcome Measures:
  • Determining the efficacy and safety of BOTOX injections • The change in number of headache free days; • % days with headache; • Average headache severity; • Number of headache episodes (number of headaches). [ Designated as safety issue: Yes ]

    The primary objective of this study is to determine the efficacy and safety of BOTOX injections in the treatment of forward head posture with associated Episodic Headache Disorder through:

    • The change in number of headache free days;
    • % days with headache;
    • Average headache severity;
    • Number of headache episodes (number of headaches).


Secondary Outcome Measures:
  • Determining the efficacy and safety of BOTOX injections [ Designated as safety issue: Yes ]
    • To determine the efficacy and safety of BOTOX injections on the change in forward head posture as measured by the improvement in the degree of FHP (measured in cm and finger breadths) at the primary analysis point of 8 weeks post-injection.
    • To determine the efficacy and safety of BOTOX injections on the change in myofascial pain measured on visual analog scale scores.


Estimated Enrollment: 30
Study Start Date: September 2009
Arms Assigned Interventions
Placebo Comparator: Saline Drug: Saline
Active Comparator: Botox Drug: Botox

Detailed Description:

This is a multi-center, prospective, double-blind, placebo-controlled parallel study investigating the use of BOTOX in the treatment of patients with FHP and associated headache using a novel fixed site injection paradigm.

Fifteen subjects will be randomized to receive BOTOX® and fifteen will receive placebo injections. Study subjects will receive one cycle of injections, up to a maximal total dosage of 250U. The study duration is approximately 4 months and is composed of a Screening Visit (Visit 1, Month -1), a Baseline Visit (Visit 2, Day 0), and three Follow-Up Visits 1 month apart (Months 1, 2 and 3).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Outpatient, healthy male or female volunteers of any race, >18 years of age. Females of childbearing potential must have a negative urine pregnancy test result at the Baseline Visit and practice a reliable method of contraception throughout the study;

    A female is considered of childbearing potential unless she is:

    • postmenopausal for at least 12 months prior to study drug administration;
    • without a uterus and/or both ovaries; or
    • has been surgically sterile for at least 6 months prior to study drug administration.

    Reliable methods of contraception are:

    • hormonal methods must be started at least 90 days prior to study drug administration
    • intrauterine device in use > 30 days prior to study drug administration; or
    • barrier methods plus spermicide in use at least 14 days prior to study drug administration.
    • partner has had a vasectomy at least 3 months previously or a confirmatory 0 sperm count test.

      • Female subjects of childbearing potential who are not sexually active are not required to practice a reliable method of contraception. They may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study.
  2. Diagnosis of FHP with at least two-fingerbreadth head forward posture.
  3. Episodic Headache Disorder as per the following criteria:

    • < 15 headache days per month including 10-14 days/month episodic migraine (with or without aura);
    • Chronic migraine is excluded;
    • Chronic Tension type HA is excluded.
  4. Subjects able to understand the requirements and participate in the study, including completing questionnaires, maintaining a Headache Diary, signing Informed Consent, and authorizing the use/release of health and research study information.

Exclusion Criteria:

  1. Pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or of childbearing potential and not practicing reliable contraception.
  2. Patients with clinically significant spinal abnormalities (e.g., scoliosis).
  3. Presence of cervical dystonia.
  4. Medical condition that may increase risk of exposure to botulinum toxin (e.g., Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function).
  5. Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
  6. Injection Site Issues: profound atrophy or excessive muscle weakness in the target areas of injection, skin problems or infection at any of the injection sites.
  7. Subjects with an allergy or sensitivity to any component of BOTOX® (Section 5.2).
  8. Evidence of recent alcohol/drug abuse.
  9. History of poor cooperation, non-compliance with medical treatment, or unreliability.
  10. Uncontrolled systemic disease, condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound study results, or significantly interfere with study participation, and/or life expectancy less than 12 months
  11. Participation in an investigational drug or device study within 30 days of the Screening/Baseline Visit.
  12. Administration of BOTOX® within the last 3 months.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350375

Contacts
Contact: Lupe Sanchez, CCRC 760-732-0557 ext 2147 lsanchez@neurocenter.com
Contact: April Tenorio, CCRC 760-732-0557 ext 2135 tenorioa@neurocenter.com

Locations
United States, California
The Research Center of Southern California Recruiting
Oceanside, California, United States, 92056
Contact: Lupe Sanchez, CCRC    760-732-0557 ext 2147    lsanchez@neurocenter.com   
Contact: April Tenorio, CCRC    760-732-0557 ext 2135    tenorioa@neurocenter.com   
Principal Investigator: Andrew Blumnefeld, MD         
Sponsors and Collaborators
The Research Center of Southern California
  More Information

No publications provided

Responsible Party: Andrew Blumenfeld, MD, The Research Center of Southern California
ClinicalTrials.gov Identifier: NCT01350375     History of Changes
Other Study ID Numbers: BTX0805
Study First Received: May 6, 2011
Last Updated: May 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Headache
Headache Disorders
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014