A Study to Test if Fremanezumab Reduces Headache in Patients With Posttraumatic Headache (PTH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03347188|
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Headache||Drug: Fremanezumab Drug: Placebo||Phase 2|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)|
|Actual Study Start Date :||November 17, 2017|
|Actual Primary Completion Date :||March 13, 2020|
|Actual Study Completion Date :||June 3, 2020|
675 mg of fremanezumab administered as 3 sc injections (225 mg/1.5 mL each ) at week 0, week 4, and week 8.
1 subcutaneous dose regimen
Other Name: TEV-48125
Placebo Comparator: Placebo
4.5 mL of placebo administered as 3 sc injections (1.5 mL each ) at week 0,week 4, and week 8.
1 subcutaneous dose regimen
- mean change from baseline (run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of the IMP [ Time Frame: Baseline-Week 12 ]
- proportion of patients reaching at least 50% reduction in the monthly average number of headache days of any severity [ Time Frame: Baseline-Week 12 ]
- mean change in the number of headache days of at least moderate severity [ Time Frame: during the first 4-week period, the 5- to 8-week period, and the 9- to 12-week period after the first dose ]
- mean change in disability score, as measured by the 6-item Headache Impact Test (HIT-6) [ Time Frame: Baseline, Week 12 after the first dose ]Six questions asked about the effect the headache has on normal daily life and ability to function. Each can be rated: Never (6 points), Rarely (8 points), Sometimes (10 points), Very often (11 points), Always (13 points). A higher total number represents a worse outcome.
- occurrence of adverse events [ Time Frame: 28 weeks ]
- Number (%) of patients who did not complete the study [ Time Frame: Day 56 ]
- Number (%) of patients who did not complete the study due to adverse events [ Time Frame: Day 56 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347188
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|