The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints that relate to this objective are as follows:
* Adverse events and serious adverse events
* Vital signs
* Electrocardiogram parameters
* Laboratory safety tests
* Columbia-Suicide Severity Rating Scale
Secondary outcome
Secondary objectives and endpoints are as follows:
To investigate the maintenance of effect during long-term treatment with
BIIB074 in subjects with neuropathic PLSR.
For all efficacy assessments, Baseline will be the 1-week period prior to
randomization (at Day 15, Week 2) into Study 1014802-203.
* Efficacy endpoints in neuropathic pain:
* Change from Baseline to Week 52 in the weekly average of the daily
neuropathicpain* score on the 11-point Pain IntensityNumerical Rating Scale;
subjects will be asked every evening to rate their overall neuropathic pain for
the last 24-hour period.
*Neuropathic pain will be evaluated in the worse affected leg, as identified on
Day 1 of Study 1014802-203
* 50% neuropathic pain reduction response (yes/no) at Week 52, where a response
is defined as a *50% reduction in the weekly average of the daily neuropathic
pain score from Baseline to Week 52
* 30% neuropathic pain reduction response (yes/no) at Week 52, where a response
is defined as a *30% reduction in the weeklyaverage of the daily neuropathic
pain score from Baseline to Week 52
* Changes from Baseline in the weekly average of the daily neuropathic pain
score at each visit
* Efficacy endpoint in low back pain:
* Change from Baseline to Week 52 in the weekly average of the daily pain score
for low back pain; subjects will be asked everyevening to rate their overall
low back pain for the last 24-hour period
To evaluate the impact of treatment with BIIB074 on quality of life
* Patient Global Impression of Change responder (yes/no) at Week 52, where a
responder is defined as either *much improved* or *very
much improved*
* Change from Baseline to Week 52 on the Oswestry Disability Index
* Change from Baseline to Week 52 in the weekly average of the daily sleep
score; subjects will be asked every morning to rate on the 11-point
Sleep Numerical Rating Scale how leg pain interfered with their sleep quality
* Change from Baseline to Week 52 in the Brief Pain Inventory (BPI) *
Interference index
* Change from Baseline (Week 2) to Week 52 inthe BPI * Pain index
* Change from Baseline to Week 52 on theEuroQoL 5-Dimension 5-Level
Questionnairehealth index
* Change from Baseline to Week 52 in the Short Form 36 Questionnaire
Background summary
BIIB074 is a potent, state-dependent, sodium channel blocker with selectivity
for the voltage-gated sodium 1.7 subtype, and based on nonclinical and clinical
data, it is hypothesized to be an effective treatment for neuropathicpain, with
a potentially better tolerability profile and a wider
therapeutic index than currently available treatments. This study will evaluate
the long-term safety and tolerability, and the maintenance of effect of BIIB074
in subjects with PLSR who have completed Study 1014802-203; PLSR is an area of
high unmet medical need, with no treatments currently
indicated specifically for this type of neuropathic pain and with other pain
medications, including opiates, being used with limited efficacy and poor
tolerability.
Study objective
The primary objective of the study is to evaluate the long-term safety and
tolerability of BIIB074 in subjects with neuropathic PLSR.
Study design
Uncontrolled, open-label extension study
Intervention
Subjects will receive an initial dose regimen of 350 mg twice daily (BID) of
BIIB074, which may be reduced to 200 mg BID based on tolerability.
Study burden and risks
Based on clinical and nonclinical data, dose regimens of 200 and 350 mg BID are
expected to not pose an unacceptable safety risk to subjects with PLSR.
Maia Building, Babraham Research Campus N/A
Cambridge CB22 3AT
GB
Maia Building, Babraham Research Campus N/A
Cambridge CB22 3AT
GB
Listed location countries
Age
Inclusion criteria
1. Is able to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use confidential health information in accordance
with national and local subject privacy regulations.
2. Has completed Study 1014802-203 through the Week 14 (Day 99) visit. Subjects who
discontinued double-blind study treatment but continued to return for study visits through
Week 14 (Day 99) and document their pain scores are eligible unless there are safety
concerns.
Exclusion criteria
1. Had a major protocol deviation regarding inclusion or exclusion criteria for the doubleblind
Phase 2b study (Study 1014802-203).
2. Had a treatment-related AE or SAE that would pose an increased risk for continued
treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b
study (Study 1014802-203) due to an AE or SAE.
3. Did not return for study visits through Week 14 (Day 99) after discontinuing treatment in
the double-blind phase of the Phase 2b study.
4. Is unable to enroll in the 1014802-204 Study on the 1014802-203 Week 14 (Day 99)
visit.
5. Other unspecified reasons that, in the opinion of the Investigator or Convergence
Pharmaceuticals, make the subject unsuitable for enrollment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-004796-68-NL |
| CCMO | NL59147.091.16 |