Safety and Efficacy Study of Botox in the Treatment of Forward Head Posture With Associated Episodic Headache Disorder
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|ClinicalTrials.gov Identifier: NCT01350375|
Recruitment Status : Unknown
Verified April 2011 by The Research Center of Southern California.
Recruitment status was: Recruiting
First Posted : May 9, 2011
Last Update Posted : May 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Forward Head Posture With Associated Episodic Headache Disorder||Drug: Botox Drug: Saline||Phase 2 Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2009|
|Placebo Comparator: Saline||
|Active Comparator: Botox||
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01350375
|Contact: Lupe Sanchez, CCRC||760-732-0557 ext email@example.com|
|Contact: April Tenorio, CCRC||760-732-0557 ext firstname.lastname@example.org|
|United States, California|
|The Research Center of Southern California||Recruiting|
|Oceanside, California, United States, 92056|
|Contact: Lupe Sanchez, CCRC 760-732-0557 ext 2147 email@example.com|
|Contact: April Tenorio, CCRC 760-732-0557 ext 2135 firstname.lastname@example.org|
|Principal Investigator: Andrew Blumnefeld, MD|