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Single-Ascending-Dose Safety/Tolerability of NP001 in Amyotrophic Lateral Sclerosis (ALS)

NCT01091142 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2010-10-06

No results posted yet for this study

Summary

Primary objectives: To assess the safety and tolerability of ascending doses of NP001 compared to placebo in subjects with ALS.

Secondary objective: To explore the effects of NP001 on biomarkers potentially relevant to ALS.

Conditions

Interventions

DRUG

NP001

Cohort 1: 0.3 mg/kg NP001(6:2 active:placebo) Cohort 2: 1.1 mg/kg NP001(6:2 active:placebo) Cohort 3: 2.1 mg/kg NP001(6:2 active:placebo) Cohort 4: 4.3 mg/kg NP001(6:2 active:placebo)

DRUG

Placebo

Cohort 1: placebo Cohort 2: placebo Cohort 3: placebo Cohort 4: placebo

Sponsors & Collaborators

  • Neuraltus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert G. Miller, MD · Forbes Norris ALS Treatment and Research, California Pacific Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091142 on ClinicalTrials.gov