Headache is a Common and Disabling Comorbidity in People with Clinically Isolated Syndrome (P3.358)

Objective: To prospectively describe headache epidemiology and disability in people with clinically isolated syndrome (CIS). Background: Headache in multiple sclerosis (MS) is poorly understood but may be an important comorbidity. Reported frequency ranges from 4–69%. Anecdotal reports suggest it may begin with MS onset. Design/Methods: During a Canadian multicentre phase III trial of minocycline in CIS (NCT00666887) headache was prospectively evaluated at every visit using history and neurological symptom case report forms and the patient-completed migraine disability assessment (MIDAS) scale. Results: Baseline data from all 142 randomized trial subjects were included. Mean age was 35.8; 68.3% were women. At baseline 81/142 subjects (57.0%) reported any headache history; 25/142 (17.6%) were reported as migraine. Onset date was missing for 4 subjects. Onset >30 days prior to CIS was reported by 49/138 (35.5%); mean duration was 14.4 years. New headache, defined as onset not more than 30 days before CIS onset, was reported by 28/138 (20.3%); 13/138 (9.4%) reported onset concurrent with CIS onset date. The mean number of headache days over the previous 3 months was 20.8; mean headache pain score was 5.6/10. Amongst migraine subjects the mean number of headache days was 19.4; mean pain was 5.8/10. Headache disability amongst those reporting headache was little/none in 63.0%, mild in 8.6%, moderate in 7.4% and severe in 21.0%. Disability amongst those reporting migraine was little/none in 48.0%, mild in 12.0%, moderate in 8.0%, and severe in 32.0%. Conclusions: Headache is a common comorbidity in people with CIS, beginning near CIS onset in 20.3% of subjects. It may contribute to morbidity as 21.0% with headache, and 32% with migraine reported severe headache disability. Management of headaches in CIS/MS may reduce the disability caused by this comorbidity. Further analysis of headache and its relationship to features of CIS, at baseline and during this 2-year trial, is ongoing. Disclosure: Dr. Liu has nothing to disclose. Dr. Metz has received research support from Roche. Dr. Lavorato has nothing to disclose. Dr. Greenfield has nothing to disclose. Dr. Amoozegar has received personal compensation from Allergan and Tribute Pharmaceuticals as honoraria. Dr. Amoozegar has received research support from Eli Lilly, Allergan, Amgen, and Teva. Dr. Traboulsee has received personal compensation for activities with Genzyme and Roche as a consultant. Dr. Traboulsee has received research support from Genzyme, Roche, and Chugai. Dr. Duquette has received personal compensation for activities with Berlex, Biogen, EMD Serono, Novartis, and Teva Neuroscience. Dr. Yeung has received personal compensation for activities with Biogen, Novartis, EMD Serono, Teva Canada Innovation, and Novartis as a speaker and/or consultant. Dr. Kremenchutzky holds stock and/or stock options in Bayer, Biogen Idec, Genzyme, Novartis, Sanofi, Teva. Dr. Vorobeychik has received personal compensation for activities with Berlex, Biogen, EMD Serono, Teva, Pfizer and Novartis for serving on advisory boards. Dr. Bhan has received personal compensation for activities with Biogen Idec, EMD Serono, Sanofi Genzyme, Novartis, Roche and Teva. Dr. Freedman has received personal compensation for activities with Actelion, Bayer Healthcare, Biogen Idec, Chugai, EMD Canada, Genzyme, Merck Serono, Novartis, Hoffman La-Roche, Sanofi-Aventis, Teva Canada Innovation as a speaker, consultant, member of a company advisory board or board of director. Dr. Blevinshas received personal compensation for activities with Biogen, Teva Neuroscience, EMD Serono Inc., Novartis, and GlaxoSmithKline, Inc as a consultant. Dr. Marriot has received personal compensation for activities with Roche, Biogen, and EMD Serono. Dr. Grand-Maison has received personal compensation for activities with Genzyme and Biogen Idec. Dr. Grand-Maison has research support from ONO, Mitsubishi, Novartis, Roche, BiogenIdec, and Opexa. Dr. Lee has received personal compensation from Novartis Canada, Serono Canada and Biogen Idec for consulting services on Advisory boards. Dr. Thibault has nothing to disclose. Dr. Minocycline in CIS Trial Investigators has nothing to disclose.