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Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

Primary Purpose

Prader-Willi Syndrome

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RGH-706

Placebo

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring Prader-Willi Syndrome, Obesity, Hyperphagia control

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Age Limits:

In United States (USA), minimum age will be 17 years old.
In European Union (EU) countries, minimum age will be 18 years old.

Inclusion Criteria:

Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening
Genetically confirmed diagnosis of PWS
HQ-CT total score ≥14 at screening
Body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs
Stable body weight
Negative pregnancy test for females of childbearing potential and nonlactating at screening.
Patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable)
Patients must have at least 1 consistent and reliable primary caregiver

Exclusion Criteria:

Severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months)
Risk of suicide according to the investigator's judgment
Uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration
Poorly controlled hypothyroidism or hyperthyroidism
Chronic or acute liver disease
History of bariatric surgery procedure
Severe obstructive sleep apnea.
History of malignancy within 5 years of screening
Systolic blood pressure (BP) ≥160 mmHg and/or diastolic BP ≥100 mmHg, pulse rate ≥100/min at screening.
Use of weight-lowering pharmacotherapy within 6 months prior to screening.
Known QT prolongation
Clinically relevant laboratory abnormalities
Any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study

Sites / Locations

Rady Children's Hospital-San DiegoRecruiting
Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
Maimonides Medical CenterRecruiting
NYU Langone Hospital-Long IslandRecruiting
Morgan Stanley Children's Hospital of NewYork-PresbyterianRecruiting
University Hospitals Cleveland Medical CenterRecruiting
University of Utah School of Medicine
General University HospitalRecruiting
Fakultní Nemocnice v MotoleRecruiting
Centre Hospitalier Universitaire d'AngersRecruiting
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude HuriezRecruiting
Centre Hospitalier Lyon-SudRecruiting
Hôpital LarreyRecruiting
Azienda Ospedaliero-Universitaria CareggiRecruiting
Istituto Giannina GasliniRecruiting
Azienda Ospedaliera Universitaria "Federico II"Recruiting
Fondazione Policlinico Universitario Agostino GemelliRecruiting
IRCCS Ospedale Pediatrico Bambino GesùRecruiting
Oasi Maria SSRecruiting
Hospital General Universitario Dr. BalmisRecruiting
Hospital General Universitario Gregorio Maranon-Instituto Provincial de Psiquiatria y Salud MentalRecruiting
Hospital Universitario 12 de OctubreRecruiting
Hospital Universitario Virgen de la VictoriaRecruiting
Hospital Regional Universitario de Málaga - Hospital GeneralRecruiting
Parc Taulí Sabadell Hospital UniversitariRecruiting
Hospital Universitario Virgen del RocíoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RGH-706

Placebo

Arm Description

Part A: Dose A once daily for 6 weeks Part B: Dose B, Dose C or Dose D once daily (depending on the randomized arm) for 13 weeks

Part A: Placebo once daily for 6 weeks Part B: Placebo once daily for 13 weeks

Outcomes

Primary Outcome Measures

Part A: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

The HQ-CT is a questionnaire designed to measure symptoms of food-related preoccupations, problems, and behaviors completed by the caregiver. The scale provides a composite value from 9 questions, each rated on a scale of 0 to 4 units (possible total score range: 0 to 36). Higher scores represent increased hyperphagia.

Part B: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

Secondary Outcome Measures

Part A and Part B: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

The HQ-CT is a questionnaire designed to measure symptoms of food-related preoccupations, problems, and behaviors completed by the caregiver. It consists of 9 items, with a 2-week recall period. The scale provides a composite value from 9 questions, each rated on a scale of 0 to 4 units (possible total score range: 0 to 36). Higher scores represent increased hyperphagia.

Part A and Part B: Change from baseline in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) domain scores (drive and severity, self-directed behavior)

Part A and Part B: Absolute change from baseline in body weight

Part A and Part B: Percentage change from baseline in body weight

Part A and Part B: Change from baseline in waist circumference

Part A and Part B: Change from baseline in body mass index (BMI)

Part A and Part B: Change from baseline in metabolic biomarkers measured from serum

Part A and Part B: Change from baseline in Clinical Global Impression-Severity (CGI-S)

The CGI-S rates overall symptom severity on a 4-point scale ranging from 1 (normal) to 7 (severely symptomatic), as assessed by the investigator.

Part A and Part B: Clinical Global Impression-Improvement (CGI-I)

The CGI-I is a single statement designed to assess the investigator's overall perception of change in the patient's condition across the course of the clinical trial. The CGI-I uses a 7-point response scale ranging from 1 (very much improved) to 7 (very much worse).

Part A and Part B: Change from baseline in Caregiver Global Impression-Severity (CaGI-S)

The CaGI-S rates severity of the patient's food-related behavior assessed by the caregiver following a 4-point scale ranging from 0 (none) to 3 (severe).

Part A and Part B: Caregiver Global Impression-Change (CaGI-C)

The CaGI-C is a single item designed to assess the primary caregiver's overall perception of change in the patient's hyperphagia symptoms. Responses are rated using a 7-point scale ranging from 1 (much better) to 7 (much worse).

Part A and Part B: Change from baseline in Zarit Burden Interview-22 (ZBI-22)

The ZBI-22 is a self-reported questionnaire in which primary caregivers rate the level of burden currently experienced while taking care of the patient rated on a 5-point scale ranging from 0 (never) to 4 (nearly always).

Part A and Part B: Safety - Incidence of treatment-emergent adverse events (TEAEs)

Part A and Part B: Safety - Incidence of clinically significant findings in laboratory values

Clinical laboratory evaluations (hematology, clinical chemistry, coagulation and lipids, thyroid function test, and urinalysis)

Part A and Part B: Safety - Incidence of clinically significant findings in vital signs

Vital signs measurements (body temperature, pulse rate, respiration rate, blood pressure [BP])

Part A and Part B: Safety - Incidence of clinically significant findings in 12-lead electrocardiograms (ECGs)

Part A and Part B: Safety - Incidence of clinically significant findings in Columbia-Suicide Severity Rating Scale (C-SSRS)

The C-SSRS is a clinician-rated instrument that captures the occurrence, severity, and frequency of suicidal ideation and/or behavior during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if suicidal ideation and/or behavior occurred.

Part A and Part B: Safety - Incidence of clinically significant findings in laboratory values physical examinations

Part B: Change from baseline in total body mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Part B: Change from baseline in lean body mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Part B: Change from baseline in total fat mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Part B: Change from baseline in visceral fat mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Part B: Change from baseline in subcutaneous fat mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Full Information

NCT ID

NCT05322096

First Posted

March 25, 2022

Last Updated

June 22, 2023

Sponsor

Gedeon Richter Plc.

1. Study Identification

Unique Protocol Identification Number

NCT05322096

Brief Title

Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

Official Title

A Randomized, Double-blind, Placebo-controlled, Multi-center, 2-part, Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 22, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gedeon Richter Plc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management. This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prader-Willi Syndrome

Keywords

Prader-Willi Syndrome, Obesity, Hyperphagia control

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RGH-706

Arm Type

Experimental

Arm Description

Part A: Dose A once daily for 6 weeks Part B: Dose B, Dose C or Dose D once daily (depending on the randomized arm) for 13 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Part A: Placebo once daily for 6 weeks Part B: Placebo once daily for 13 weeks

Intervention Type

Drug

Intervention Name(s)

RGH-706

Intervention Description

Capsules Oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules Oral administration

Primary Outcome Measure Information:

Title

Part A: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

Description

Time Frame

Part A: Baseline to Day 42

Title

Part B: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

Description

Time Frame

Part B: Baseline to Day 105

Secondary Outcome Measure Information:

Title

Part A and Part B: Change from baseline in the 9-item Hyperphagia Questionnaire for Clinical Trials (HQ-CT)

Description

Time Frame

Part A: Baseline to Days 28, 56, 98 and 133; Part B: Baseline to Days 42, 70 and 119

Title

Part A and Part B: Change from baseline in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) domain scores (drive and severity, self-directed behavior)

Description

Time Frame

Part A: Baseline to Days 28, 42, 56, 98 and 133; Part B: Baseline to Days 42, 70, 105 and 119

Title

Part A and Part B: Absolute change from baseline in body weight

Time Frame

Part A: Screening, Days 1, 14, 28, 42, 56, 98 and 133; Part B: Screening, Days 1, 14, 28, 42, 70, 105 and 119

Title

Part A and Part B: Percentage change from baseline in body weight

Time Frame

Part A: Screening, Days 1, 14, 28, 42, 56, 98 and 133; Part B: Screening, Days 1, 14, 28, 42, 70, 105 and 119

Title

Part A and Part B: Change from baseline in waist circumference

Time Frame

Part A: Screening, Days 1, 14, 28, 42, 56, 98 and 133; Part B: Screening, Days 1, 14, 28, 42, 70, 105 and 119

Title

Part A and Part B: Change from baseline in body mass index (BMI)

Time Frame

Part A: Screening, Days 1, 14, 28, 42, 56, 98 and 133; Part B: Screening, Days 1, 14, 28, 42, 70, 105 and 119

Title

Part A and Part B: Change from baseline in metabolic biomarkers measured from serum

Time Frame

Part A: Baseline to Day 42; Part B: Baseline to Days 42, 70 and 105

Title

Part A and Part B: Change from baseline in Clinical Global Impression-Severity (CGI-S)

Description

The CGI-S rates overall symptom severity on a 4-point scale ranging from 1 (normal) to 7 (severely symptomatic), as assessed by the investigator.

Time Frame

Part A: Baseline to Days 28, 42 and 56; Part B: Baseline to Days 42, 70, 105 and 119

Title

Part A and Part B: Clinical Global Impression-Improvement (CGI-I)

Description

Time Frame

Part A: Days 28 and 42; Part B: Baseline to Days 42, 70 and 105

Title

Part A and Part B: Change from baseline in Caregiver Global Impression-Severity (CaGI-S)

Description

The CaGI-S rates severity of the patient's food-related behavior assessed by the caregiver following a 4-point scale ranging from 0 (none) to 3 (severe).

Time Frame

Part A: Baseline to Days 2 and 42; Part B: Baseline to Days 42, 70 and 105

Title

Part A and Part B: Caregiver Global Impression-Change (CaGI-C)

Description

Time Frame

Part A: Days 28, 42, 56, 98 and 133; Part B: Days 42, 70, 105 and 119

Title

Part A and Part B: Change from baseline in Zarit Burden Interview-22 (ZBI-22)

Description

Time Frame

Part A: Baseline to Day 42; Part B: Baseline to Day 105

Title

Part A and Part B: Safety - Incidence of treatment-emergent adverse events (TEAEs)

Time Frame

Part A: Screening thru study end; Up to 24 weeks; Part B: Screening to end of study; Up to 17 weeks

Title

Part A and Part B: Safety - Incidence of clinically significant findings in laboratory values

Description

Clinical laboratory evaluations (hematology, clinical chemistry, coagulation and lipids, thyroid function test, and urinalysis)

Time Frame

Part A: Screening thru study end; Up to 24 weeks; Part B: Screening to end of study; Up to 17 weeks

Title

Part A and Part B: Safety - Incidence of clinically significant findings in vital signs

Description

Vital signs measurements (body temperature, pulse rate, respiration rate, blood pressure [BP])

Time Frame

Part A: Screening thru study end; Up to 24 weeks; Part B: Screening to end of study; Up to 17 weeks

Title

Part A and Part B: Safety - Incidence of clinically significant findings in 12-lead electrocardiograms (ECGs)

Time Frame

Part A: Screening thru study end; Up to 24 weeks; Part B: Screening to end of study; Up to 17 weeks

Title

Part A and Part B: Safety - Incidence of clinically significant findings in Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

Time Frame

Part A: Screening thru study end; Up to 24 weeks; Part B: Screening to end of study; Up to 17 weeks

Title

Part A and Part B: Safety - Incidence of clinically significant findings in laboratory values physical examinations

Time Frame

Part A: Screening thru study end; Up to 24 weeks; Part B: Screening to end of study; Up to 17 weeks

Title

Part B: Change from baseline in total body mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Time Frame

Part B: Baseline to Day 105

Title

Part B: Change from baseline in lean body mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Time Frame

Part B: Baseline to Day 105

Title

Part B: Change from baseline in total fat mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Time Frame

Part B: Baseline to Day 105

Title

Part B: Change from baseline in visceral fat mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Time Frame

Part B: Baseline to Day 105

Title

Part B: Change from baseline in subcutaneous fat mass measured by Lunar dual-energy X-ray absorptiometry (iDXA)

Time Frame

Part B: Baseline to Day 105

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Age Limits: In United States (USA), minimum age will be 17 years old. In European Union (EU) countries, minimum age will be 18 years old. Inclusion Criteria: Male or female patients aged ≥17 years in USA at screening or aged ≥18 years in EU at screening Genetically confirmed diagnosis of PWS HQ-CT total score ≥14 at screening Body weight ≥40 kg/88 lbs and ≤200 kg/450 lbs Stable body weight Negative pregnancy test for females of childbearing potential and nonlactating at screening. Patients must be able to provide or have a parent or guardian who is able to provide written informed consent and/or assent (as applicable) Patients must have at least 1 consistent and reliable primary caregiver Exclusion Criteria: Severe psychiatric disorders (eg, schizophrenia, bipolar disorder, or major depressive disorder), recent (within 6 months) Risk of suicide according to the investigator's judgment Uncontrollable diabetes mellitus or diabetes mellitus requiring insulin administration Poorly controlled hypothyroidism or hyperthyroidism Chronic or acute liver disease History of bariatric surgery procedure Uncontrolled obstructive sleep apnea. History of malignancy within 5 years of screening Systolic blood pressure (BP) ≥160 mmHg and/or diastolic BP ≥100 mmHg, pulse rate ≥100/min at screening. Use of weight-lowering pharmacotherapy within 6 months prior to screening. Known QT prolongation Clinically relevant laboratory abnormalities Any other condition that, in the investigator's opinion, might indicate that the patient is unsuitable for the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Medical Information Scientific Service

Phone

+36 1 505 7032

medinfo@richter.hu

Facility Information:

Facility Name

Rady Children's Hospital-San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lynne Bird, MD

Facility Name

Ann & Robert H. Lurie Children's Hospital of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Priya Khanna, MD

Facility Name

Maimonides Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deepan Singh, MD

Facility Name

NYU Langone Hospital-Long Island

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Mejia-Corletto, MD

Facility Name

Morgan Stanley Children's Hospital of NewYork-Presbyterian

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vidhu Thaker, MD

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Mitchell, MD,PhD

Facility Name

University of Utah School of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Individual Site Status

Suspended

Facility Name

General University Hospital

City

Prague

ZIP/Postal Code

12808

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Matoulek, MD,PhD

Facility Name

Fakultní Nemocnice v Motole

City

Prague

ZIP/Postal Code

15000

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stanislava Kolouskova, MD,PhD

Facility Name

Centre Hospitalier Universitaire d'Angers

City

Angers

ZIP/Postal Code

49933

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederic Illouz, MD

Facility Name

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Recruiting

Facility Name

Centre Hospitalier Lyon-Sud

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuel Disse, MD,PhD

Facility Name

Hôpital Larrey

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emilie Montastier, MD

Facility Name

Azienda Ospedaliero-Universitaria Careggi

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Vignozzi, MD,PhD

Facility Name

Istituto Giannina Gaslini

City

Genova

ZIP/Postal Code

16147

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppa Patti, MD

Facility Name

Azienda Ospedaliera Universitaria "Federico II"

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Silvia Savastano, MD,PhD

Facility Name

Fondazione Policlinico Universitario Agostino Gemelli

City

Roma

ZIP/Postal Code

168

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe Zampino, MD

Facility Name

IRCCS Ospedale Pediatrico Bambino Gesù

City

Roma

ZIP/Postal Code

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danilo Fintini, MD

Facility Name

Oasi Maria SS

City

Troina

ZIP/Postal Code

94018

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Letizia Ragusa, MD

Facility Name

Hospital General Universitario Dr. Balmis

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Hospital General Universitario Gregorio Maranon-Instituto Provincial de Psiquiatria y Salud Mental

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Covadonga Martinez Diaz-Caneja, MD

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Calatayud Gutierrez, MD

Facility Name

Hospital Universitario Virgen de la Victoria

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Tinahones Madueno, MD,PhD

Facility Name

Hospital Regional Universitario de Málaga - Hospital General

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Carlos Fernandez Garcia, MD

Facility Name

Parc Taulí Sabadell Hospital Universitari

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria-Assumpta Caixas Pedragos, MD,PhD

Facility Name

Hospital Universitario Virgen del Rocío

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Pablo Garcia Luna, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

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