Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS

Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
20
Phase:
1
Treatment Type:
Drug: BHV-0223
Trial Type:
Single Group Assignment, open-label
Sponsor:
Biohaven Pharmaceutical Holding Company Ltd.
Primary Investigator:
Contact Information:
    Contact information unknown.

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
N/A
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
N/A
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
N/A
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

5/14/2018Trial added

Locations:

Holy Cross Neuroscience Research Institute, Fort Lauderdale, 33334
Neurosciences Institute, Neurology - Charlotte , Charlotte, 28207
Somnos/Neurology Associates Clinical Research, Lincoln, 68506
Wesley Neurology Clinic , Cordova, 38018
Texas Neurology, Dallas, 75214

Other Information:

Purpose: Phase 1, open-label study of BHV-0223 in ALS.
Eligibility: 18 Years and older, all genders, not accepting healthy volunteers
Details: This is a phase 1, open-label, single arm study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of BHV-0223 in subjects with ALS.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 5/14/2018
ClinicalTrials.gov ID: NCT03520517
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov