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Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - Follow-Up

- 6/23/19 - 1 form, 7 itemgroups, 36 items, 1 language

Itemgroups: Administrative documentation, Pregnancy Tests, Vital Signs, Electrocardiography, Laboratory Procedures, Abnormality, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Abnormality, Laboratory Procedures, Urinalysis, Abnormality

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Investigatioinal Product Use and Status of Treatment Blind

- 11/2/18 - 1 form, 3 itemgroups, 7 items, 1 language

Itemgroups: Administrative Data, Investigational Product Use, Status of Treatment Blind

This ODM-file contains the form to document the investigational product use and the status of treatment blind. To be assessed at the final visit. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - End of Study

- 10/24/19 - 1 form, 7 itemgroups, 20 items, 1 language

Itemgroups: Administrative documentation, Date of visit, Assessment Date, Pharmacogenetic Test, Informed Consent, Withdraw, Blinded Clinical Study, Status, Medical Devices, Question, Pregnancy, Information, Clinical Trials, Conclusion

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146 - End of Study Record

- 7/3/19 - 1 form, 2 itemgroups, 6 items, 1 language

Itemgroups: Administrative documentation, Clinical Trials, End

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

- 10/31/18 - 1 form, 5 itemgroups, 13 items, 1 language

Itemgroups: Administrative Data, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature

This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log as well as the investigator's signature. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Study Conclusion

- 2/1/19 - 1 form, 4 itemgroups, 10 items, 1 language

Itemgroups: Administrative Data, Study Conclusion, Investigator Comment Log, Signature

Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders This form contains the conclusion of the study, it should be filled out at the final visit.

Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784 - Study Conclusion and Pregnancy Information

- 11/25/18 - 1 form, 3 itemgroups, 8 items, 1 language

Itemgroups: Administrative Data, Study Conclusion, Pregnancy Information

This form contains a form to document the study conclusion and pregnancy information. To be assessed at the follow-up visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - LOG Visit

- 6/20/18 - 1 form, 15 itemgroups, 122 items, 2 languages

Itemgroups: Date of Visit/Assessment, Adverse event, Log status, Concomitant Medications, Non-serious adverse event, Report, Randomisation, Serious Adverse Event, Intensity changes, Seriousness, Relevant concomitant/treatment medications, Relevant diagnostic results, investigational product, General narrative comments, Non clinical

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - End of Study

- 6/19/18 - 1 form, 6 itemgroups, 21 items, 1 language

Itemgroups: Date of Visit/Assessment, Status of Treatment Blind, Pregnancy, Withdrawal of Consent for PGx (DNA)/Sample Destruction, Study conclusion, Investigators signature

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Study Conclusion, Pregnancy Information and Investigator Comment Log

- 9/27/21 - 1 form, 5 itemgroups, 14 items, 1 language

Itemgroups: Administrative Data, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature

This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - Logs and Repeats

- 9/17/21 - 1 form, 2 itemgroups, 12 items, 1 language

Itemgroups: Administrative Data, Adverse Event | Concomitant Medication | Evaluation

This form documents if any measurements were repeated during the study, if concomitant medications were taken or if any adverse events or ECG abnormalities occurred. To be assessed at study conclusion. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784 - Telemetry and Summary Telemetry Abnormalities

- 9/17/21 - 1 form, 4 itemgroups, 81 items, 1 language

Itemgroups: Administrative Data, Dosing Date and Time, Telemetry, Summary Telemetry Abnormalities

This form contains a form to document the telemetry and the summary telemetry abnormalities. To be assessed at visits V1-V3. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

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