Recruiting
Phase 1

CC100

Sponsor:

Chemigen, LLC

Code:

NCT03049046

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

CC100

Placebos

Study Details

Brief summary:

Approximately 21 subjects with amyotrophic lateral sclerosis (ALS) will be randomized (6 to 1) to receive by mouth seven morning doses of CC100 or placebo for 7 days. Subjects are required to stay in the Clinic for approximately 9 hours following the first and last dose. Subjects will also have a mid-week clinic visit and will be contacted by phone within 3 to 5 days after the last dose.

Funding Source - FDA OOPD

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT03049046

Start date

Apr 7, 2017

Status verified date

Aug, 2017

Completion date

Mar 30, 2018

Anticipated

Primary completion date

Jan 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have definite or probable ALS with a forced vital capacity of >60% predicted.
  • Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal.
  • Riluzole is allowed if dose has been stable for at least 30 days. Other allowed medications: lipid-lowering drugs, anti-hypertensives, anti-depressants, oral medications for type II diabetes, estrogen replacement therapy, thyroid replacement therapy, antihistamines, antacids, nonsteroidal anti-inflammatory drugs (except indomethacin), histamine H2-receptor antagonists, proton-pump inhibitors, calcium supplements, topical eye medications, and topical antibiotics.

Exclusion Criteria:

  • Greater than 250 pounds
  • Have serious or unstable illnesses as determine by the investigator.
  • Have current or a history of asthma or severe drug allergies or pollen allergy.
  • Have had serious infectious disease affecting the brain within the preceding 5 years; or have existing evidence of serious infection.
  • Have laboratory test values that are considered clinically significant as determined by the investigators.
  • Have ECG abnormalities that are clinically significant.
  • Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing.
  • Have a history of chronic alcohol or drug abuse within the past 2 years.

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CC100 250 mg

CC100 250 mg once daily by mouth for 7 days

active comparator: CC100 500 mg

CC100 500 mg once daily by mouth for 7 days

active comparator: CC100 1000 mg

CC100 1000 mg once daily by mouth for 7 days

placebo comparator: Placebo

Placebo once daily by mouth for 7 days

Interventions

CC100

synthetic caffeic acid phenethylester

Placebos

Diluent

Primary outcome measure

  • Safety and Tolerability: Adverse events, safety labs, vital signs, and ECGs [ Time Frame: From start of first dose to a minimum of 3 days after last dose ]

Central Contacts and Locations

Locations

Indiana University, IU Health Physicians Neurology

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sandra Guingrich, LPN, CCRC

317-963-7382sguingri@iu.edu

Principal Investigator:

Robert Pascuzzi, MD

More Information

Sponsor

Chemigen, LLC

Last update posted

Aug 3, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chemigen, LLC on 2017-08-03.