BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy

Sciatica Clinical Trial

— SPRINT  

Official title:

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of BG00010 (Neublastin) in Subjects With Painful Lumbar Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873404
• Other study ID #: 103NS201
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2013
• Last updated: August 27, 2015
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week.

The secondary objectives of this study in this study population are as follows: To explore the duration of the effect of BG00010 in improving pain; To explore the dose response curve on pain reduction; To assess the safety and tolerability of BG00010; To assess the serum exposure to BG00010.

Description:

During the study, frequent assessment of allocation probability will be conducted to guide subsequent randomization of participants into dose groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Body weight =133 kg.

• Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within =6 months and =5 years of the time of randomization.

• Objective, documented evidence of painful lumbar radiculopathy involvement

• Lower back pain

• Leg pain

• Male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.

Key Exclusion Criteria:

• History of or positive test result at screening for human immunodeficiency virus, or for hepatitis C virus antibody, or current Hepatitis B infection.

• Clinically significant diseases or conditions as determined by the investigator.

• Major surgery within 30 days prior to the Screening Visit or that is scheduled to occur during the study.

• Previous participation in a study with neurotrophic factors (e.g., nerve growth factor).

• Participation in a study with another investigational drug or approved therapy for investigational use within 3 months prior to Day 1.

• Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Painful Lumbar Radiculopathy
• Radiculopathy
• Sciatica

Intervention

Drug:
• BG00010
As specified in the treatment arm
• Placebo
As specified in the treatment arm

Locations

Country	Name	City	State
United States	Research Site	Bloomington	Illinois
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Georgia
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Evansville	Indiana
United States	Research Site	Fresno	California
United States	Research Site	Ft. Lauderdale	Florida
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lomita	California
United States	Research Site	Long Beach	California
United States	Research Site	Orlando	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Pasadena	California
United States	Research Site	Phoenix	Arizona
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Sarasota	Florida
United States	Research Site	Savannah	Georgia
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Sunrise	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score		At the end of treatment period (Day 6-10)	No
Secondary	Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score		At the end of the treatment period (day 6-10)	No
Secondary	Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)		At the end of the treatment period (day 6-10)	No
Secondary	Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)		Up to week 5	No
Secondary	Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)		Up to week 5	No
Secondary	Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)		Up to week 5	No
Secondary	Maximum observed serum concentration (Cmax) of BG00010		Up to Day 5	No
Secondary	Number of participants experiencing adverse events (AEs)		Up to week 9	Yes
Secondary	Number of participants experiencing serious adverse events (SAEs)		Up to week 9	Yes
Secondary	Change from Baseline in Incidence of neutralizing antibodies in serum		Up to week 9	Yes