Cephalalgia
Abstracts of the European Headache and Migraine Trust International Congress 2008
not such that treatment choices should be based primarily on
(Topamax®) on frequency and intensity of chronic migraine
tolerability. They are better based on efficacy.
(CM) episodes. Methods In this single-center, double-blind trial, patients received either BoNTA, maximum 200 U at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), +placebo Chronic daily headache; migraine-prevention
topiramate, or topiramate, 4-week titration to 100 mg/day
therapy and tension type headaches
with option for additional 4-week titration to 200 mg/day, + placebo BoNTA (saline injections). The primary endpoint
was treatment responder rate assessed using Physician Global Assessment (PGA) 9-point scale. Headache disability was
Chronic daily headache treated non-pharmaceutically with
measured using Headache Impact Test (HIT-6), headache
an nociceptive trigeminal inhibition dental splint
diary, Migraine Disability Assessment (MIDAS), and Migraine Impact Questionnaire. The Headache Center of Southern California, Encinitas, California, USAResults Of 60 patients randomized to treatment (mean age, 37 y; 90% female), 33 completed the study at 9.5 months Background The NTI (Nociceptive Trigeminal Inhibition)
(BoNTA, 18/30 [60%]; topiramate, 15/30 [50%]). In the topi-
intraoral device is FDA approved for the prophylactic treat-
ramate group, 53.3% discontinued study because of adverse
ment of medically diagnosed migraine pain and is hypothe-
events (AEs) vs 25% in the BoNTA group. Between 68% and
sized to reduce noxious afferent activity through reduction of
82% of subjects reported some improvement at months 1, 3,
intensity of nocturnal hyperactive trigeminal motor activity
6, and 9 in PGA for both BoNTA and topiramate groups. No
significant between-group differences were observed, except
Methods 20 consecutive CDH patients, all who scored ‘severe
for marked improvement at month 9 (BoNTA, 27.3% vs topi-
and disabling’ on their HIT-6 questionnaire, were properly
ramate, 60.9%, P = 0.0234, Chi-sq). In both groups, headache-
fitted with an NTI device and wore nightly for 9 months. HIT-
days decreased and MIDAS and HIT-6 scores improved. 41
6 questionnaires were complete at 4 weeks, 8 weeks, and 9
treatment-related AEs were reported in 18 BoNTA-treated
months following the initial fitting.
subjects vs 87 in 25 topiramate-treated subjects. Results By the fourth week of nocturnal NTI use, nearly 75% Conclusions BoNTA and topiramate showed equivalent effi-
reported significant positive improvements in their HIT-6
cacy in the prophylactic treatment of CM. Patients receiving
scores. By the second month, all HIT-6 scores had stabilized.
BoNTA had fewer AEs and discontinuations.
Following seven months of continual nocturnal NTI use, 50% reported considerable improvement in the quality of their lives, with half of those reporting that their headaches no
longer had any impact on their lives, while another reported experiencing only ‘some’ negative impact. Health-Related Quality of Life (HRQL) of patients eligible Conclusions The considerable long-term improvement on for prophylactic headache treatment with botulinum toxin
the lives of the majority of patients with severe and disabling
type A (BoNTA) in the Program to Assess Headache
intractable Chronic Daily Headache over a nine-month period,
Treatment Strategies (PATS)
well after the cessation of placebo effect as a confounding
Marmura M1, Shaw J2, Yu S2, Silberstein S1
factor, suggests that intense nocturnal jaw clenching and
1Jefferson Headache Center, Jefferson Medical College, Philadelphia, PA,
resultant nociceptive input to the trigeminal sensory nucleus
USA, 2Dept of Pharmacy Administration, University of Illinois at Chicago, Chicago, IL, USA
should be considered as a perpetuating co-factor of CDH attack frequency and severity. An NTI device, provided by an
Objective PATS was conducted to assess the safety and effec-
experienced and knowledgeable practitioner, should be con-
tiveness of BoNTA (BOTOX®: Allergan, Inc.) for headache
sidered an important non-pharmacologic prescribed thera-
(HA) prophylaxis in specialty care patients. Presented are
peutic option for improving the quality of life of severe
baseline patient characteristics and their associations with
indicators of HRQL. Methods HRQL was assessed using the Headache Pain- Specific Quality of Life (HPSQL) questionnaire. Associations
of HA diagnosis, frequency, and severity with HPSQL item
Comparison of botulinum toxin type A (BoNTA) and
and total scores were evaluated by ordered logistic
topiramate for the prophylactic treatment of chronic migraine: double-blind pilot study Results 703 patients were enrolled. Nearly 66% had a chronic migraine diagnosis. Average HA frequency one month prior
to enrollment was negatively related to HRQL with a 1-day
Houston Headache Clinic, Houston, TX, USA
increase in frequency associated with a greater likelihood of
Background There is a need for effective prophylactic
HA pain interfering with mood (4%, p < 0.001), recreational
migraine therapy that has minimal side effects.
activities (4%, p = 0.004), or life enjoyment (4%, p = 0.001).
Objective Determine the effect of prophylactic treatment of
Co-existing health conditions and HA severity were nega-
botulinum toxin type A (BoNTA; BOTOX®) and topiramate
tively associated with HRQL. Patients who reported severe
Blackwell Publishing Ltd Cephalalgia, 2009, 29, 101–178
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