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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03274856
Other study ID # GLWL-PWS
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 20, 2018
Est. completion date June 12, 2019

Study information

Verified date March 2020
Source GLWL Research Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the treatment of patients with Prader-Willi Syndrome (PWS).


Description:

Participants will be assigned to one of two treatment sequences (GLWL-01/Placebo or Placebo/GLWL-01), with each sequence consisting of two treatment periods separated by a washout period


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date June 12, 2019
Est. primary completion date June 12, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- Confirmed diagnosis of PWS based on genetic confirmation using DNA method

- Body mass index (BMI) of 27 to 60 kg/m2

- No evidence of weight excursion beyond 10% of baseline weight

- Patients must provide assent and have a reliable caregiver (must have been caring for the patient for at least 6 months) who provides a separate written informed consent to participate. The caregiver is expected to be the primary caregiver throughout the study and must be in frequent contact with the patient (defined as at least 4 awake hours per day). The caregiver must be able to communicate with site personnel and in the investigator's opinion must have adequate literacy to complete questionnaires. If a caregiver cannot continue, 1 caregiver replacement is allowed

- Are on a stable diet and exercise regimen for >2 months prior

Exclusion Criteria:

- Current enrollment in or discontinuation within the last 30 days from a clinical trial involving any investigational drug or device

- Are currently living in a group home for more than 50% of the time

- A history or presence of other medical illness that indicates a medical problem that would preclude study participation

- Have an estimated glomerular filtration rate <60 mL/minute/1.73 m2. Have macroalbuminuria (defined as spot urine albumin to creatinine ratio of >300 µg/mg) or hematuria

- Are hypertensive (defined as sitting systolic blood pressure (BP) greater than or equal to (=)140 millimeters of mercury (mmHg) and diastolic BP =90 mmHg)

- Patients on weight loss medications within 30 days of dosing, or with a history of bariatric surgery

- Unable to refrain from or anticipates the use of:

1. Any drugs known to be significant inhibitors of Cytochrome P450, family 3, subfamily A (CYP)3A enzymes and/or P-glycoprotein (P-gp) including regular consumption of grapefruit or grapefruit juice for 14 days prior to the first dose. Acetaminophen (up to 2 grams per 24-hour period) may be permitted

2. Any drugs known to be significant inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzymes and/or P-gp, including St. John's Wort

3. Any medications that prolong the QT/QTc interval, unless the participant has been stable on the medication for at least 3 months and has a corrected QT interval (QTc) <450 msec

- Currently taking simvastatin >10 mg per day, atorvastatin >20 mg per day, or lovastatin >20 mg per day, or have a history of statin-induced myopathy/rhabdomyolysis

- Unsuitable for inclusion in the study in the opinion of the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GLWL-01
Oral administration of 3 capsules, twice a day
Placebo
Oral administration of 3 capsules, twice a day

Locations

Country Name City State
Canada Alberta Diabetes Institute, University of Alberta Edmonton Alberta
Canada Centre Hospitalier Universitaire Ste-Justine Montreal Quebec
Canada CRCHUM Montreal Quebec
United States University Hospitals, Cleveland Medical Center Cleveland Ohio
United States University of Florida Gainesville Florida
United States Vanderbilt University Nashville Tennessee
United States Rady Children's Hospital San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
GLWL Research Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-treatment Total Score on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) GLWL-01 compared with placebo on the post-treatment HQ-CT score. Total range of score of zero to 36, with higher score indicating a worse outcome. Up to approximately 4 weeks of double-blind treatment
Secondary Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs Evaluate the safety and tolerability of GLWL-01 Baseline up to approximately 18 weeks
Secondary Caregiver Global Impression of Change (CGIC) GLWL-01 compared with placebo in the CGIC. Score ranges from 1 to 7, with larger number indicating a worse outcome. Up to approximately 4 weeks of double-blind treatment
Secondary Area Under the Concentration Versus Time Curve From Time Zero to 12 Hours (AUC0-12) Pharmacokinetics (PK) after single and multiple oral dosing Day 14 and Day 42, pre-dose, and 0.5, 1, 2, 4, 6, and between 8 and 12 hours postdose
Secondary Maximum Observed Drug Concentration (Cmax) Pharmacokinetics after single and multiple oral dosing Day 14 and Day 42, pre-dose, and 0.5, 1, 2, 4, 6, and between 8 and 12 hours postdose
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