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Completed

NCT Number: NCT01873404

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Phoenix, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BG00010

Drug

As specified in the treatment arm

Other names: Neublastin

Placebo

Drug

As specified in the treatment arm

Primary outcomes

  1. Change from Baseline in the mean 24-hour average general pain intensity (AGPI) score

    Time frame: At the end of treatment period (Day 6-10)

Secondary outcomes

  1. Change from Baseline in the mean 24-hour average back pain intensity (ABPI) score

    Time frame: At the end of the treatment period (day 6-10)

  2. Change from Baseline in the mean 24-hour average leg pain intensity score (ALPI)

    Time frame: At the end of the treatment period (day 6-10)

  3. Change from Baseline in the individual mean 24-hour average general pain intensity (AGPI)

    Time frame: Up to week 5

  4. Change from Baseline in the individual mean 24-hour average back pain intensity (ABPI)

    Time frame: Up to week 5

  5. Change from Baseline in the individual mean 24-hour average leg pain intensity (ALPI)

    Time frame: Up to week 5

  6. Maximum observed serum concentration (Cmax) of BG00010

    Time frame: Up to Day 5

  7. Number of participants experiencing adverse events (AEs)

    Time frame: Up to week 9

  8. Number of participants experiencing serious adverse events (SAEs)

    Time frame: Up to week 9

  9. Change from Baseline in Incidence of neutralizing antibodies in serum

    Time frame: Up to week 9

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Acronym: SPRINT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2013
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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