Forward Head Posture With Associated Episodic Headache DisorderPhase 2/3NCT01350375
Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder
A Phase 2/3 study testing Botox and Saline in people with Forward Head Posture With Associated Episodic Headache Disorder, run by The Research Center of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture With Associated Episodic Headache Disorder
- What is being tested?
- Botox and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2013
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Diagnosis of FHP with at least two-fingerbreadth head forward posture.
- 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.
- 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.
Who cannot join
- Pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or of childbearing potential and not practicing reliable contraception.
- Patients with clinically significant spinal abnormalities (e.g., scoliosis).
- Presence of cervical dystonia.
- 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).
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- 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.
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- Subjects with an allergy or sensitivity to any component of BOTOX® (Section 5.2).
- Evidence of recent alcohol/drug abuse.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- 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
- Participation in an investigational drug or device study within 30 days of the Screening/Baseline Visit.
- Administration of BOTOX® within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Research Center of Southern California
Oceanside, California, 92056
About this study
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
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.
Read the 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).
- Being tested
- Botox, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
| Botox | Active comparator | Not described Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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).
Measured: 4 months
Secondary outcomes (1)
Determining the efficacy and safety of BOTOX injections
- 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head Posture With Associated Episodic Headache DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Research Center of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Tenorio, The Research Center of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350375
- Sponsor's protocol ID
- BTX0805
- Status last verified
- Sep 2019
- First submitted
- 6 May 2011
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No