E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Trigeminal Nerve Disorder |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10044652 |
E.1.2 | Term | Trigeminal neuralgia |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to evaluate the efficacy of BIIB074 in treating pain experienced by subjects with TN.
The primary objective of the LTE phase of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with TN. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include the following: - To investigate the safety and tolerability of BIIB074 in subjects with TN. - To evaluate the population PK of BIIB074.
The secondary objective of the LTE is to investigate the maintenance of effect during Long-term treatment with BIIB074 in subjects with TN. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- A diagnosis of TN for at least 3 months based on IHS diagnostic criteria. - Participant must have failed at least 1 prior standard of care pharmacologic treatment for TN (defined as an inadequate response or intolerance to treatment), as determined by the Investigator based on medical history. NOTE: Other protocol defined Inclusion criteria may apply |
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E.4 | Principal exclusion criteria |
- History or positive test result at Screening for hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). - Positive history of human immunodeficiency virus (HIV) or a positive HIV test at Screening. - Participants with facial pain other than TN. - Personal or family (first-degree relative) history of seizures (except for simple febrile convulsions) or clinically significant head injury. NOTE: Other protocol defined Exclusion criteria may apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period.
A participant who meets all of the following criteria will be classified as a responder:
(1) Has a reduction of ≥30% in mean pain score compared with baseline (2) Has not discontinued randomized treatment before the end of Week 12 of the double-blind period (3) Has not taken prohibited pain medication before the end of Week 12 of the double-blind period
The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to week 52. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is the proportion of subjects classified as responders at Week 12 of the double-blind period.
The primary endpoint of LTE phase is the number of participants experiencing AEs and SAEs during the LTE from Baseline up to Week 52. |
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E.5.2 | Secondary end point(s) |
•To investigate the safety and tolerability of BIIB074 in subjects with TN The endpoint that relates to this objective is the incidence of adverse events (AEs) and serious adverse events (SAEs) during the double blind period. •To evaluate the population pharmacokinetics of BIIB074 The endpoints that relate to this objective include area under the concentration time curve and maximum observed concentration at steady state.
The secondary endpoints of LTE phase include the following: - Proportion of subjects with a response based on a ≥30% reduction in mean pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE compared with baseline (run-in) - Change from baseline in mean pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE - Change from baseline in mean worst pain score during 4-week periods beginning on Day 1 through Week 52 of the LTE - Proportion of subjects with a response based on a ≥50% reduction in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 52 of the LTE compared with baseline (run-in) - Change from baseline in mean number of paroxysms during 4-week periods beginning on Day 1 through Week 52 of the LTE - Proportion of subjects with a PGIC response of “much improved” or “very much improved” by visit during the LTE - Change from baseline in the PENN-FPS-R score by visit during the LTE - Change from baseline in the EQ-5D-5L score by visit during the LTE - Change from baseline in the WPAI: Neuropathic Pain (V2.0) score by visit during the LTE |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 12 and Week 52 for LTE phase endpoints |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 61 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Austria |
Belgium |
Bulgaria |
Canada |
Denmark |
Estonia |
Finland |
Germany |
Korea, Republic of |
Russian Federation |
Serbia |
Slovakia |
Switzerland |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |