Forward Head Posture With Associated Episodic Headache Disorder Clinical Trial
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
| Verified date | September 2019 |
| Source | The Research Center of Southern California |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Research Center of Southern California | Oceanside | California |
| Lead Sponsor | Collaborator |
|---|---|
| The Research Center of Southern California |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). |
4 months | |
| Secondary | 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. |
4 months |