Last updated: 11/07/2018 04:50:24
MT400-303 GR43175 An Open-Label, Repeat Dose Study of the Safety and Efficacy of Combo Formulation in the Treatment of Multiple Episodes of Acute Migraine Over 12 Months
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: MT400-303 GR43175 An Open-Label, Repeat Dose Study of the Safety and Efficacy of Combo Formulation in the Treatment of Multiple Episodes of Acute Migraine Over 12 Months
Trial description: MT400-303 GR43175 An Open-Label, Repeat Dose Study of the Safety and Efficacy of Combo Formulation in the Treatment of Multiple Episodes of Acute Migraine Over 12 Months
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Brandes JL, Cady RK, Smith TR, Lener S, Zhang Y, Alexander WJ Interim analysis of the long-term safety study of a new single-tablet formulation of sumatriptan formulated with RT Technology™ and naproxen sodium. Cephalalgia 2005; 25: 1203.
Cady R, Brandes JL, Derosier F, Lener SE. Evaluation of the Relationship of Demographic Variables and Tolerability of a Fixed-Dose, Single-Tablet Formulation of Sumatriptan 85mg Formulated with RT Technology™ and Naproxen Sodium 500mg (SumaRT/Nap). Poster presentation at: National Headache Foundation’s 5th Annual Headache Research Summit; February 19, 2008; Scottsdale, AZ.
Cady RK, Brandes JL, Smith TR, Lener S, Zhang Y, Alexander WJ. Six month interim analysis of the long-term safety study of a new single-tablet formulation of sumatriptan formulated with RT Technology™ and naproxen sodium. Presented at: National Headache Foundation’s 3rd Annual Headache Research Summit; February 15-16, 2006; Palm Springs, CA.
Smith T, Blumenthal H, Diamond M, Mauskop A, Ames M, McDonald S, Lener S, Burch S. Long-term clinical and patient-reported benefits of a fixed single-tablet formulation of sumatriptan with RT TechnologyTM and naproxen sodium in a moderate/severe treatment paradigm. Headache 2006;46(5):865 (Abs No F61).
Winner P, Cady RK, Ruoff GE, Frishberg BM, Alexander WJ, Zhang Y, Kori SH, Lener SE. Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine. Mayo Clin Proc 2007;82(1):61-68.
Winner PK, Adelman JU, Ruoff G, Alexander WJ, Lener S, Kori S. Long-term safety and tolerability of a new single-tablet formulation of sumatriptan formulated with RT technologyTM and naproxen sodium. Neurology 2006; 66 (5 Suppl 2):A43 (Abs No P01.125).
Winner PK, Brandes JL, Lener SE, Derosier F, White J, and McDonald SA. Evaluation of the Relationship Body Mass Index (BMI) to Response and Tolerability after Treatment with a Single Fixed-Dose Tablet of Sumatriptan 85mg formulated with RT Technology/Naproxen Sodium 500mg (SumaRT/Nap) for the Acute Treatment of Migraine. Headache 2008: S47.
Winner PK, Cady R, Ruoff G, Frishberg BM, Zhang Y, Alexander WJ, Kori SH, Lener S. Long-term safety and tolerability of a fixed single-tablet formulation of sumatriptan RT TechnologyTM and naproxen sodium in the acute treatment of migraine. Headache 2006;46(5):859 (Abs No F47).
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
May 2004 to August 2005
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-18-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Access to clinical trial data by researchers
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