Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Pain From Lumbosacral Radiculopathy
- Conditions
- europathic Pain From Lumbosacral RadiculopathyMedDRA version: 21.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004796-68-IT
- Lead Sponsor
- CONVERGENCE PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 302
The candidates must meet the following eligibility criteria at enrollment, or at the timepoint specified in the individual eligibility criterion listed:
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.
3. All women of childbearing potential and all men must practice effective contraception during the study and for 5 weeks for women and 14 weeks for men, after their last dose of study treatment.
4. Subjects may take up to 1 permitted medication for neuropathic pain
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 323
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at enrollment, or at the timepoint specified in the individual criterion listed:
1.Had a major protocol deviation regarding inclusion or exclusion criteria for the double-blind 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.
6. Has met withdrawal criteria for the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
7. Is pregnant or lactating (female subjects only).
8. Male subjects whose partner is pregnant.
9. Has a history of suicide attempt since participating in the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
10. Has a history of any liver disease, with the exception of known Gilbert's disease since participating in the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
11. Has a history of alcohol or substance abuse (as determined by the Investigator).
12. Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders.
13. Currently has a history of uncontrolled or poorly controlled hypertension.
14. Has a history or presence of significant cardiovascular, gastrointestinal, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
15. Has a history or presence of any clinically significant abnormality in vital signs, ECG, or laboratory tests or has any medical or psychiatric condition that, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety.
16. Has had an episode of major depression since participating in the preceding double-blind phase 2b study for PLSR (Study 1014802-203).
17. Is unable to comply with the permitted and prohibited medications
18. Is mentally or legally incapacitated
19. Is unable to comply with study requirements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.;Secondary Objective: Secondary objectives of the study are:<br>- To investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with neuropathic PLSR<br>-To evaluate the impact of treatment with BIIB074 on quality of life;Primary end point(s): The primary endpoints that relate to this objective are as follows:<br>1. AEs and SAEs<br>2. Vital signs<br>3. ECG parameters<br>4. Laboratory safety tests<br>5. Columbia-Suicide Severity Rating Scale (C-SSRS);Timepoint(s) of evaluation of this end point: 1.-5. From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU)
- Secondary Outcome Measures
Name Time Method