BIIB074
DrugAdministered as specified in the treatment arm
Other names: CNV1014802
Completed
NCT Number: NCT02917187
A Phase 2a Study of BIIB074 in the Treatment of Erythromelalgia
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Research Site, Birmingham, Alabama, United States
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About this study
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
- A diagnosis of primary inherited EM with family history of EM made at least 3 months from initial diagnosis.
- Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment).
- Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.
Key Exclusion Criteria:
- Positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result.
- Received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to Day 1.
- Males whose partner is pregnant.
- Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment).
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Treatment and study plan
Placebo
DrugMatched placebo
Primary outcomes
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Weekly average severity of paroxysms
Time frame: Day 1 to Week 12
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.
Secondary outcomes
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Weekly maximum severity of paroxysms
Time frame: Day 1 to Week 12
The weekly maximum severity is the maximum paroxysm severity recorded by a participant in a given week.
-
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
Time frame: Day 1 to Week 12
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.
-
Patient Global Impression of Change (PGIC) score
Time frame: Day 1 to Week 12
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."
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Weekly average and weekly maximum number of pain-mitigating activities
Time frame: Day 1 to Week 12
Participant diary is used to record pain mitigating cooling activities that include but are not limited to use of cold water or fan.
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Weekly average and weekly maximum duration of pain-mitigating activities
Time frame: Day 1 to Week 12
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.
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Use of rescue medication
Time frame: Day 1 to Week 13
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Weekly average and weekly maximum of the daily sleep interference scale
Time frame: Day 1 to Week 12
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".
-
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
Time frame: Up to Week 13
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."
Sponsors and collaborators
Lead sponsor
Biogen
Industry
Registry information
Official study title
An Exploratory, Randomized, Double-Blind, Crossover Study to Compare the Efficacy and Safety of BIIB074 Versus Placebo in the Treatment of Primary Inherited Erythromelalgia
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Sep 28, 2016
- Registry last updated
- Jan 10, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.