A Phase 2 interventional study of BIIB074 and Placebo in Primary Inherited Erythromelalgia, sponsored by Biogen. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Biogen · Phase 2, Interventional, and Treatment
The primary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on paroxysmal pain in participants with Primary Inherited Erythromelalgia (EM). The secondary objective of the study is to investigate the efficacy of repeat oral dosing of BIIB074 on varying additional aspects of pain in participants with EM; and to investigate the safety and tolerability of repeat oral dosing of BIIB074 in participants with EM.
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
After two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period
Drug: BIIB074 · Drug: Placebo
After two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period
Drug: BIIB074 · Drug: Placebo
Administered as specified in the treatment arm
Also known as: CNV1014802
Matched placebo
Weekly average severity of paroxysms
11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess EM paroxysmal pain. PI-NRS is an 11-point pain intensity numerical rating scale, where 0=no pain and 10=worst possible pain. Weekly average is defined as the total of severity scores during a week divided by the total number of paroxysms during that week.
Time frame: Day 1 to Week 12
Weekly maximum severity of paroxysms
The weekly maximum severity is the maximum paroxysm severity recorded by a participant in a given week.
Time frame: Day 1 to Week 12
Weekly average and maximum number of paroxysms
Time frame: Day 1 to Week 12
Weekly average and weekly maximum duration of paroxysms
Time frame: Day 1 to Week 12
Weekly average and weekly maximum of daily background pain
Each participant provides a daily background pain score via a diary that records background daily pain intensity using a numerical rating scale from 0-10 with higher scores indicating worse pain.
Time frame: Day 1 to Week 12
Patient Global Impression of Change (PGIC) score
PGIC is a 7-point self-report scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Time frame: Day 1 to Week 12
Weekly average and weekly maximum number of pain-mitigating activities
Participant diary is used to record pain mitigating cooling activities that include but are not limited to use of cold water or fan.
Time frame: Day 1 to Week 12
Weekly average and weekly maximum duration of pain-mitigating activities
Participant diary is used to record pain mitigating activities that include but are not limited to use of cooling, and breathing/relaxation and mental imagery techniques.
Time frame: Day 1 to Week 12
Use of rescue medication
Time frame: Day 1 to Week 13
Weekly average and weekly maximum of the daily sleep interference scale
Daily Sleep Interference Scale (DSIS) describes how much EM pain interfered with the participant's sleep with 0 indicating "pain did not interfere with sleep" and 10 indicating "pain completely interfered with sleep".
Time frame: Day 1 to Week 12
Weekly average and weekly maximum number of awakenings at night due to EM pain
Time frame: Day 1 to Week 12
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Week 13
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to Week 13
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to Week 13
Number of participants with clinically significant laboratory safety test abnormalities
Time frame: Up to Week 13
Columbia-Suicide Severity Rating Scale (C-SSRS) assessment
C-SSRS is a suicidal ideation rating used to evaluate suicidality. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
Time frame: Up to Week 13
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Erythromelalgia
Biogen