Trial record 5 of 59 for:    Open Studies | "Anorexia"

Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rhythm Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01642550
First received: July 13, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.


Condition Intervention Phase
Anorexia Nervosa
Drug: RM-131
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Rhythm Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Effect of RM-131 on body weight [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline in body weight.


Secondary Outcome Measures:
  • Effect of RM-131 on gastric emptying time [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline in gastric half-emptying time (t1/2).

  • Effect of RM-131 on appetite [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline in appetite.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RM-131 Drug: RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Placebo Comparator: Placebo Drug: RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months;
  • Age 18-45 years old;
  • Gastrointestinal tract symptoms;
  • Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH);
  • Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;
  • Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures, including daily SC injections and completion of a daily injection log.
  • Patient has a primary care physician or treatment team managing her care.

Exclusion Criteria:

  • Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening;
  • Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;
  • History of diabetes mellitus;
  • History of purging behaviors greater than once monthly within the last three months;
  • Active substance abuse;
  • Use of metoclopramide, erythromycin, 5HT3 anti-emetics, or opioid medications within 2 weeks prior to baseline. [Note: these drugs should also not be used post-baseline];
  • Hematocrit < 30.0 %, hemoglobin < 10.0 g/dl, potassium < 3.0 mmol/L, fasting glucose > 100 mg/dL, creatinine > 1.5 mg/dL, AST or ALT > 1.5 times the upper limit of normal, or abnormal plasma thyroid stimulating hormone (TSH) level;
  • Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression;
  • History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection;
  • Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease;
  • Active suicidal ideation;
  • Beck Depression Inventory-2 score of ≥ 29;
  • Current inpatient hospitalization;
  • Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal;
  • Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study;
  • Any other reason, which in the opinion of the Investigator, including severe renal, hepatic or cardiac disease, would confound proper interpretation of the study or expose a patient to unacceptable risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642550

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ildiko Gaal       IGAAL@PARTNERS.ORG   
Sponsors and Collaborators
Rhythm Pharmaceuticals, Inc.
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01642550     History of Changes
Other Study ID Numbers: RM-131-005
Study First Received: July 13, 2012
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhythm Pharmaceuticals, Inc.:
Anorexia nervosa
Anorexia
Eating disorders

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014