Last updated: 11/07/2018 19:36:46

An open 6-month-study for the treatment of acute migraine attacks with sumatriptan (6 mg subcutaneous (sc). plus optional 6 mg sc) using an autoinjector, complemented by a) the possibility to prolong the study up to 18 months in total; and/or complemented by b) the possibility to assess quality ...

GSK study ID
SUMAI 01
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open 6-month-study for the treatment of acute migraine attacks with sumatriptan (6 mg subcutaneous (sc). plus optional 6 mg sc) using an autoinjector, complemented by a) the possibility to prolong the study up to 18 months in total; and/or complemented by b) the possibility to assess quality ...
Trial description: An open 6-month-study for the treatment of acute migraine attacks with sumatriptan (6 mg subcutaneous (sc). plus optional 6 mg sc) using an autoinjector, complemented by a) the possibility to prolong the study up to 18 months in total; and/or complemented by b) the possibility to assess quality ...
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:
Göbel H et al. New advance in headache research 4: Edit. F. Clifford Rose, Proceedings of the 10th Migraine Trust Symposium, London, Sept. 1994; 189-194
Göbel H, Heinze A, Stolze N, Heinze-Kuhn K, Lindner V. Open labelled long-term study of the efficacy, safety, and tolerability of subcutaneous sumatriptan in acute migraine treatment. Cephalalgia 1999; 19:676-683
Göbel H, Stolze, H, Heinze A, Dworschak M, Heuss D, Christiani K, Lindner V (1996). Achtzehnmonatige Langzeitanalyse der Wirksamkeit, Sicherheit und Verträglichkeit von Sumatriptan s.c. in der Akuttherapie von Migräneanfällen. Nervenarzt 67:471-483
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
October 1991 to June 1993
Type
Not applicable
Phase
3

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

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
1993-15-06

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

Not applicable
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