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OpenTrials
Completed

NCT Number: NCT00961766

Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.

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Key information

Conditions

Sciatica Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.
  • Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.
  • Must rate their pain at >40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.

Key Exclusion Criteria:

  • History of malignancy or clinically significant (as determined by the Investigator) allergies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
  • History of signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.
  • History of severe allergic or anaphylactic drug-related reactions. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BG00010 (Neublastin)

Drug

Single dose, weight-based IV administration

Placebo

Drug

Single dose IV matched placebo

Primary outcomes

  1. Number of participants experiencing Adverse Events (AEs)

    Time frame: Up to 56 days post dosing

  2. Change in Likert numerical pain rating scale

    Time frame: Up to 56 days post dosing

  3. Change in Quantitative Sensory Test (QST)

    Time frame: Up to 28 days post dosing

    QST; Vibratory, Cool Thermal,

  4. Change in Intra Epidermal Nerve Fiber Density (IENFD)

    Time frame: Up to 28 days post dosing

  5. Maximum observed serum concentration (Cmax)

    Time frame: Up to 5 days post dosing

  6. Area under the serum concentration curve (AUC)

    Time frame: Up to 5 days post dosing

  7. Terminal half-life (t1/2)

    Time frame: Up to 5 days post dosing

  8. Total body clearance (CL)

    Time frame: Up to 5 days post dosing

  9. Steady state volume of distribution (Vss)

    Time frame: Up to 5 days post dosing

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 19, 2009
Registry last updated
Oct 28, 2014

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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