A Phase 2a Study of BIIB074 in the Treatment of Erythromelalgia

NCT02917187 | Completed Phase 2

• 1 other identifier: 1014802-205
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Primary Inherited Erythromelalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to Week 12

Secondary Outcomes (15)

• Weekly maximum severity of paroxysms

  Day 1 to Week 12

• Weekly average and maximum number of paroxysms

  Day 1 to Week 12

• Weekly average and weekly maximum duration of paroxysms

  Day 1 to Week 12

• Weekly average and weekly maximum of daily background pain

  Day 1 to Week 12

• Patient Global Impression of Change (PGIC) score

  Day 1 to Week 12

Study Arms (2)

Randomized Group 1

EXPERIMENTAL

After two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period

Drug: BIIB074; Drug: Placebo

Randomized Group 2

EXPERIMENTAL

After two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period

Drug: BIIB074; Drug: Placebo

Interventions

BIIB074 DRUG

Administered as specified in the treatment arm

Also known as: CNV1014802

Randomized Group 1; Randomized Group 2

Placebo DRUG

Matched placebo

Randomized Group 1; Randomized Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (5)

Research Site

Birmingham, Alabama, 35242, United States

Location

Research SIte

New London, Connecticut, 06320, United States

Location

Research Site

Philadelphia, Pennsylvania, 19152, United States

Location

Research Site

Plano, Texas, 75075, United States

Location

Research Site

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Interventions

vixotrigine

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: September 28, 2016
• Study Start: September 9, 2016
• Primary Completion: December 27, 2016
• Study Completion: January 5, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

US (5)